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1. Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial

Author

Rugo, HS, Diéras, V, Gelmon, KA, Finn, RS, Slamon, DJ, Martin, M, Neven, P, Shparyk, Y, Mori, A, Lu, DR, Bhattacharyya, H, Bartlett, CHUANG, Iyer, S, Johnston, S, Ettl, J, and Harbeck, N

Subjects
Breast Cancer, Estrogen, Clinical Research, Aging, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Humans, Letrozole, Middle Aged, Piperazines, Placebos, Postmenopause, Pyridines, Quality of Life, palbociclib, letrozole, health-related quality of life, metastatic breast cancer, ER+/HER2-, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundPatient-reported outcomes are integral in benefit-risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body of evidence for patient-reported health-related quality of life (QOL) for patients with metastatic breast cancer (MBC) receiving first-line endocrine-based therapy (palbociclib plus letrozole and letrozole alone).Patients and methodsTreatment-naïve postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) MBC were randomized 2 : 1 to palbociclib plus letrozole (n = 444) or placebo plus letrozole (n = 222). Patient-reported outcomes were assessed at baseline, day 1 of cycles 2 and 3, and day 1 of every other cycle from cycle 5 using the Functional Assessment of Cancer Therapy (FACT)-Breast and EuroQOL 5 dimensions (EQ-5D) questionnaires.ResultsAs of 26 February 2016, the median duration of follow-up was 23 months. Baseline scores were comparable between the two treatment arms. No significant between-arm differences were observed in change from baseline in FACT-Breast Total, FACT-General Total, or EQ-5D scores. Significantly greater improvement in pain scores was observed in the palbociclib plus letrozole arm (-0.256 versus -0.098; P = 0.0183). In both arms, deterioration of FACT-Breast Total score was significantly delayed in patients without progression versus those with progression and patients with partial or complete response versus those without. No significant difference was observed in FACT-Breast and EQ-5D index scores in patients with and without neutropenia.ConclusionsOverall, women with MBC receiving first-line endocrine therapy have a good QOL. The addition of palbociclib to letrozole maintains health-related QOL and improves pain scores in treatment-naïve postmenopausal patients with ER+/HER2- MBC compared with letrozole alone. Significantly greater delay in deterioration of health-related QOL was observed in patients without progression versus those who progressed and in patients with an objective response versus non-responders. ClinicalTrials.gov: NCT01740427 (https://clinicaltrials.gov/ct2/show/NCT01740427).

Published
2018

2. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study

Author

Jimenez, M.M., Johnston, S., Boyle, F., Steger, G.G., Neven, P., Jiang, Z., Campone, M., Huober, J., Shimizu, C., Cicin, I., Wardley, A., Tolaney, S.M., Abuin, G.G., Zarba, J., Lim, E., Sant, P., Liao, N., Christiansen, B., Eigeliene, N., Martin-Babau, J., Ettl, J., Mavroudis, D., Chiu, J., Boer, K., Nagarkar, R., Paluch-Shimon, S., Moscetti, L., Sagara, Y., Kim, S.-B., Maciel, M.M., Tjan-Heijnen, V., Broom, R., Lacko, A., Schenker, M., Volkov, N., Sim Yap, Y., Coccia-Portugal, M., Ángel García Sáenz, J., Andersson, A., Chao, T.-Y., Gokmen, E., Harputluoglu, H., Berzoy, O., Patt, D., McArthur, H., Chew, H., Chalasani, P., Kaufman, P., Tedesco, K., Graff, S.L., Harbeck, N., Rastogi, P., Martin, M., Shao, Z.M., Fasching, P.A., Huang, C.S., Jaliffe, G.G., Tryakin, A., Goetz, M.P., Rugo, H.S., Senkus, E., Testa, L., Andersson, M., Tamura, K., Del Mastro, L., Kreipe, H., Hegg, R., Sohn, J., Guarneri, V., Cortés, J., Hamilton, E., André, V., Wei, R., Barriga, S., Sherwood, S., Forrester, T., Munoz, M., Shahir, A., San Antonio, B., Nabinger, S.C., Toi, M., Johnston, S.R.D., and O’Shaughnessy, J.

Published
2021
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3. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Bachelot, T., Bouzid, K., Campone, M., Desmoulins, I., Coudert, B., Bondarenko, I., Nowecki, Z., Glogowska, I., Ciruelos Gil, E., Errihani, H., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Paluch-Shimon, S., Wardley, A., Schneeweiss, A., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Puglisi, F., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Miles, D., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhász, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vásques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M.J., Illarramendi Mañas, J., Martinez De Dueñas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcón Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., McCarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Böess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferraù, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., López, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Müller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H.M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeño, M., Ruohola, J., Berdah, J.-F., Goncalves, A., Orfeuvre, H., Grischke, E.-M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D’Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., García Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M.H., Martínez Jañez, N., Mele Olive, M., McAdam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Grève, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kütner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Lück, H.-J., Zahm, D.-M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C.H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Viñas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kühn, T., Ober, A., Repp, R., Schröder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Pérez Martínez, M., van de Wouw, A.J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Antón Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florián Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Björneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodríguez, R., Ciruelos, E., Peretz-Yablonski, T., Merot, J.-L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., and Klingbiel, D.

Published
2021
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5. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bouzid, Kamel, Campone, Mario, Coudert, Bruno, Nowecki, Zbigniew, Errihani, Hassan, Dalenc, Florence, Ferreira, Ana, Mano, Max, Ricci, Francesco, Kalofonos, Haralabos, Andreetta, Claudia, Montemurro, Filippo, Barrett, Sophie, Zhang, Qingyuan, Mavroudis, Dimitris, Matus, Juan, Beato, Carlos, Hu, Xichun, Gaafar, Rabab, Abdel Azeem, Hamdy, Perrin, Christophe, Ettl, Johannes, Lang, Istvan, Verma, Sunil, Li, Huiping, Brain, Etienne, Hoffmann, Oliver, Cariello, Anna, Tondini, Carlo, Altwegeiri, Taher, Loman, Niklas, Lux, Michael, Frassoldati, Antonio, Aziz, Zeba, Salas, Fernando, Streb, Joanna, Wronski, Andrzej, Menjón Beltrán, Salomón, Cicin, Irfan, Schmid, Peter, Laing, Robert, Tong, Zhongsheng, Boer, Katalin, Juhasz, Balazs, Gianni, Luca, Curigliano, Giuseppe, Juarez, Alejandro, Susnjar, Snezana, Matos, Erika, Uslu, Ruchan, Wildiers, Hans, Cruz, Marcelo, Bourgeois, Hugues, von Schumann, Raquel, Stemmer, Salomón, Vásquez, Flavia Morales, Dominguez, Adriana, Wojtukiewicz, Marek, Trifunovic, Jasna, Illarramendi, Jose Juan, Garcia, Laura, Peron, Yann Izarzugaza, Echarri, Maria Jose, Voitko, Natliia, Wheatley, Duncan, Waters, Simon, De Boer, Richard, Jerusalem, Guy, Cocquyt, Véronique, Barrios, Carlos, Panasci, Lawrence, Mattson, Johanna, Tanner, Minna, Gozy, Michel, Vasilopoulos, Georgios, Revesz, Janos, Latini, Luciano, Gridelli, Cesare, Lazaro, Jesus, Gonzalez, Antonio, Barnadas Molins, Agusti, Martinez, Eduardo, Alarcón, Jesús, Arance, Ana, Klint, Leif, Kovalyov, Oleksiy, Baird, Richard, Yeo, Belinda, McCarthy, Nicole, Greil, Richard, Wang, Shusen, Artignan, Xavier, Augereau, Paule, Juhasz-Boess, Ingolf, Ngan, Roger, Goldberg, Hadassah, Di Costanzo, Francesco, Ferraù, Francesco, Aleknavicius, Eduardas, Rashid, Kamran, Costa, Luís, Angel Garcia, Jose, de la Cruz, Luis Ruiz, López López, Rafael, Del Val, Olga, Ozyilkan, Ozgur, Azribi, Fathi, Verrill, Mark, Turner, Nicholas, Beith, Jane, Petzer, Andreas, Andrade, Jurandyr, Bernstein, Vanessa, Rayson, Daniel, Saad Eldin, Ibtessam, Achille, Mihaëla, Mueller, Volkmar, Gennari, Alessandra, Cascinu, Stefano, Ghosn, Marwan, El-Saghir, Nagi, Van den Bosch, Joan, Oosterkamp, Rianne, Kukulska, Monika, Pelaez, Ignacio, Hernandez, Carolina, del Mar Gordon, Maria, Dalmau, Elsa, Alonso, Jose Luis, Aksoy, Sercan, Coskun, Hasan Senol, Shparyk, Yaroslav, Varughese, Mohini, Panwar, Udaiveer, Barraclough, Lisa, Levitt, Nicola, Hicks, Jonathan, Rigg, Anna, Allen, Mark, Castillo, Cecila, Fein, Luis Enrique, Stuart-Harris, Robin, Singer, Christian, Stoeger, Herbert, Smiljanic, Sasha, Feng, Jifeng, Cedeño, Miguel, Berdah, Jean Francois, Orfeuvre, Hubert, Goncalves, Anthony, Grischke, Eva-Maria, Simon, Eike, Wagner, Steffen, Efremidou, Anna, Papazisis, Konstantinos, Evron, Ella, Inbar, Moshe, Baruch, Noa Ben, Geffen, David, Karminsky, Natalya, Ruggeri, Enzo Maria, Luigi, Cavanna, Grasso, Donatella, Juozaityte, Elona, Rafael Rodriguez Cid, Jeronimo, Roerdink, Henk, Siddiqi, Neelum, Passos Coelho, José Luís, Garre, Elisa Garcia, Garcia, Andres, Martínez Jañez, Noelia, Lopez Ceballos, Maria Helena, Mele, Mireia, García, María, Arcediano, Alberto, McAdam, Karen, Perren, Timothy, Taylor, Wendy, Humphreys, Alison, Vera, Raul, Kaen, Luis Alberto, Steger, Günther, Andel, Johannes, de Grève, Jacques, Huizing, Manon, Hegg, Roberto, Joy, Anil, Sehdev, Sandeep, Kütner, Riina, Ruohola, Johanna, Dohollou, Nadine, Grosjean, Jessica, Laplaige, Philippe, Largillier, Rémy, Martin, Philippe, Pottier, Virginie, Alexandre, Jerome, Christensen, Bernd, Zahm, Dirk-Michael, Khandan, Fariba, Lueck, Hans-Joachim, Fountzilas, Georgios, Fried, Georgeta, Giacobino, Alice, Bonetti, Andrea, Guerra, Yanin Chavarri, Van Warmerdam, Laurens, Van der Velden, Annette, Vrijaldenhoven, Suzan, de Jongh, Felix, Cavero, Milagros, Andres Conejero, Raquel, Murias, Adolfo, Saura, Salvador, Oltra, Amparo, Redondo, Andres, Ribelles, Nuria, Bachmeier, Kilian, Joffe, Johnathan, Chakraborti, Prabir, Beresford, Mark, Butt, Mohammad, Poole, Christopher, Yordi, Gassan, Woodward, Natasha, Amorim, Gilberto, Califaretti, Nadia, Fox, Susan, Robidoux, Andre, Li, NanLi, Li, Nenxiao, Jiang, Jun, Soria, Tannia, Padrik, Peeter, Saarni, Outi, Genet, Dominique, Catala, Stéphanie, Barletta, Hugues, Teixeira, Luis, Facchini, Thomas, Hesse, Tobias, Kühn, Thorsten, Ober, Angelika, Repp, Roland, Schroeder, Willibald, Pectasides, Dimitrios, Bodoky, Gyorgy, Kahan, Zsuzsanna, Jiveliouk, Irina, Rosengarten, Ora, Alabiso, Oscar, Perez, Mario, Van de Wouw, Yes, Smok-Kalwat, Jolanta, Damasceno, Margarida, Sousa, Gabriela, Abulkhair, Omalkhair, Antón Torres, Antonio, Martinez, Maria Purificación, Garcia Mata, Jesús, Jesús Florián Jerico, Marta Santisteban, Llombart, Antonio, Sanchez, Rosa, Torrego, Juan Carlos, Garate, Clara Olier, Rodriguez, Cesar, Llorente, Rosa, de Prado, Diego Soto, Cortés, Javier, Llorca, Cristina, Galán, Antonio, Viñas Villaro, Gemma, Narbe, Ulrik, Bjömeklett, Helena Granstam, Westwell, Sarah, Newby, Jackie, Jafri, Mariam, Rodríguez, Robinson, Alonso, Isabel, Bachelot, T., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Bondarenko, I., Paluch-Shimon, S., Wardley, A., Merot, J.-L., du Toit, Y., Easton, V., Lindegger, N., and Miles, D.

Published
2019
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6. Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial

Author

Ettl, J., Quek, R.G.W., Lee, K.-H., Rugo, H.S., Hurvitz, S., Gonçalves, A., Fehrenbacher, L., Yerushalmi, R., Mina, L.A., Martin, M., Roché, H., Im, Y.-H., Markova, D., Bhattacharyya, H., Hannah, A.L., Eiermann, W., Blum, J.L., and Litton, J.K.

Published
2018
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8. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial

Author

Johannes Ettl, Rinat Yerushalmi, Joanne L. Blum, Henri Roché, Sami Diab, A. Goncalves, Natasha Woodward, Sara A. Hurvitz, Lida A. Mina, Yunjoo Im, Tiziana Usari, Wolfgang Eiermann, Miguel Martin, Ruben G.W. Quek, Hope S. Rugo, Kiheon Lee, Akos Czibere, Silvana Lanzalone, Jennifer K. Litton, and Annabel Goodwin

Subjects
0301 basic medicine, medicine.medical_specialty, medicine.medical_treatment, Gastroenterology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Randomized controlled trial, law, Internal medicine, medicine, Adverse effect, Chemotherapy, business.industry, Hazard ratio, Cancer, Hematology, medicine.disease, Confidence interval, ddc, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, PARP inhibitor, business
Abstract

Background In EMBRACA, talazoparib prolonged progression-free survival versus chemotherapy (hazard ratio [HR] 0.542 [95% confidence interval (CI) 0.413-0.711]; P Patients and methods This randomized phase III trial enrolled patients with gBRCA1/2-mutated HER2-negative ABC. Patients received talazoparib or physician's choice of chemotherapy. OS was analyzed using stratified HR and log-rank test and prespecified rank-preserving structural failure time model to account for subsequent treatments. Results A total of 431 patients were entered in a randomized study (287 talazoparib/144 chemotherapy) with 412 patients treated (286 talazoparib/126 chemotherapy). By 30 September 2019, 216 deaths (75.3%) occurred for talazoparib and 108 (75.0%) chemotherapy; median follow-up was 44.9 and 36.8 months, respectively. HR for OS with talazoparib versus chemotherapy was 0.848 (95% CI 0.670-1.073; P = 0.17); median (95% CI) 19.3 months (16.6-22.5 months) versus 19.5 months (17.4-22.4 months). Kaplan–Meier survival percentages (95% CI) for talazoparib versus chemotherapy: month 12, 71% (66% to 76%)/74% (66% to 81%); month 24, 42% (36% to 47%)/38% (30% to 47%); month 36, 27% (22% to 33%)/21% (14% to 29%). Most patients received subsequent treatments: for talazoparib and chemotherapy, 46.3%/41.7% received platinum and 4.5%/32.6% received a poly(ADP-ribose) polymerase (PARP) inhibitor, respectively. Adjusting for subsequent PARP and/or platinum use, HR for OS was 0.756 (95% bootstrap CI 0.503-1.029). Grade 3-4 adverse events occurred in 69.6% (talazoparib) and 64.3% (chemotherapy) patients, consistent with previous reports. Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P Conclusions In gBRCA1/2-mutated HER2-negative ABC, talazoparib did not significantly improve OS over chemotherapy; subsequent treatments may have impacted analysis. Safety was consistent with previous observations. PRO continued to favor talazoparib.

Published
2020
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9. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study

Author

Harbeck, N., primary, Rastogi, P., additional, Martin, M., additional, Tolaney, S.M., additional, Shao, Z.M., additional, Fasching, P.A., additional, Huang, C.S., additional, Jaliffe, G.G., additional, Tryakin, A., additional, Goetz, M.P., additional, Rugo, H.S., additional, Senkus, E., additional, Testa, L., additional, Andersson, M., additional, Tamura, K., additional, Del Mastro, L., additional, Steger, G.G., additional, Kreipe, H., additional, Hegg, R., additional, Sohn, J., additional, Guarneri, V., additional, Cortés, J., additional, Hamilton, E., additional, André, V., additional, Wei, R., additional, Barriga, S., additional, Sherwood, S., additional, Forrester, T., additional, Munoz, M., additional, Shahir, A., additional, San Antonio, B., additional, Nabinger, S.C., additional, Toi, M., additional, Johnston, S.R.D., additional, O’Shaughnessy, J., additional, Jimenez, M.M., additional, Johnston, S., additional, Boyle, F., additional, Neven, P., additional, Jiang, Z., additional, Campone, M., additional, Huober, J., additional, Shimizu, C., additional, Cicin, I., additional, Wardley, A., additional, Abuin, G.G., additional, Zarba, J., additional, Lim, E., additional, Sant, P., additional, Liao, N., additional, Christiansen, B., additional, Eigeliene, N., additional, Martin-Babau, J., additional, Ettl, J., additional, Mavroudis, D., additional, Chiu, J., additional, Boer, K., additional, Nagarkar, R., additional, Paluch-Shimon, S., additional, Moscetti, L., additional, Sagara, Y., additional, Kim, S.-B., additional, Maciel, M.M., additional, Tjan-Heijnen, V., additional, Broom, R., additional, Lacko, A., additional, Schenker, M., additional, Volkov, N., additional, Sim Yap, Y., additional, Coccia-Portugal, M., additional, Ángel García Sáenz, J., additional, Andersson, A., additional, Chao, T.-Y., additional, Gokmen, E., additional, Harputluoglu, H., additional, Berzoy, O., additional, Patt, D., additional, McArthur, H., additional, Chew, H., additional, Chalasani, P., additional, Kaufman, P., additional, Tedesco, K., additional, and Graff, S.L., additional

Published
2021
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10. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Miles, D., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Campone, M., additional, Bondarenko, I., additional, Nowecki, Z., additional, Errihani, H., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, Trask, P., additional, du Toit, Y., additional, Pena-Murillo, C., additional, Revelant, V., additional, Klingbiel, D., additional, Bachelot, T., additional, Bouzid, K., additional, Desmoulins, I., additional, Coudert, B., additional, Glogowska, I., additional, Ciruelos Gil, E., additional, Dalenc, F., additional, Ricci, F., additional, Dieras, V., additional, Kaufman, B., additional, Ferreira, A., additional, Mano, M., additional, Kalofonos, H., additional, Andreetta, C., additional, Montemurro, F., additional, Barrett, S., additional, Zhang, Q., additional, Mavroudis, D., additional, Matus, J., additional, Villarreal Garza, C., additional, Beato, C., additional, Ismael, G., additional, Hu, X., additional, Abdel Azeem, H., additional, Gaafar, R., additional, Perrin, C., additional, Kerbrat, P., additional, Ettl, J., additional, Paepke, S., additional, Hitre, E., additional, Lang, I., additional, Trudeau, M., additional, Verma, S., additional, Li, H., additional, Hoffmann, O., additional, Aktas, B., additional, Cariello, A., additional, Cruciani, G., additional, Tienghi, A., additional, Tondini, C., additional, Al-Twegieri, T., additional, Loman, N., additional, Laing, R., additional, Miles, D., additional, Brain, E., additional, Fasching, P., additional, Lux, M., additional, Frassoldati, A., additional, Aziz, Z., additional, Salas, J., additional, Streb, J., additional, Krzemieniecki, K., additional, Wronski, A., additional, Garcia Garcia, J., additional, Menjon Beltran, S., additional, Cicin, I., additional, Schmid, P., additional, Gallagher, C., additional, Turner, N., additional, Tong, Z., additional, Boer, K., additional, Juhász, B., additional, Horvath, Z., additional, Bianchini, G., additional, Gianni, L., additional, Curigliano, G., additional, Juarez Ramiro, A., additional, Susnjar, S., additional, Matos, E., additional, Sevillano, E., additional, Garcia Estevez, L., additional, Gokmen, E., additional, Uslu, R., additional, Wildiers, H., additional, Schutz, F., additional, Cruz, M., additional, Bourgeois, H., additional, von Schumann, R., additional, Stemmer, S., additional, Dominguez, A., additional, Morales-Vásques, F., additional, Wojtukiewicz, M., additional, Trifunovic, J., additional, Echarri Gonzalez, M.J., additional, Illarramendi Mañas, J., additional, Martinez De Dueñas, E., additional, Voitko, N., additional, Hicks, J., additional, Waters, S., additional, Barrett-Lee, P., additional, Wheatley, D., additional, De Boer, R., additional, Cocquyt, V., additional, Jerusalem, G., additional, Barrios, C., additional, Panasci, L., additional, Mattson, J., additional, Tanner, M., additional, Gozy, M., additional, Vasilopoulos, G., additional, Papandreou, C., additional, Revesz, J., additional, Battelli, N., additional, Benedetti, G., additional, Latini, L., additional, Gridelli, C., additional, Lazaro Leon, J., additional, Alarcón Company, J., additional, Arance Fernandez, A., additional, Barnadas Molins, A., additional, Calvo Plaza, I., additional, Bratos, R., additional, Gonzalez Martin, A., additional, Izarzugaza Peron, Y., additional, Klint, L., additional, Kovalev, A., additional, McCarthy, N., additional, Yeo, B., additional, Kee, D., additional, Thomson, J., additional, White, S., additional, Greil, R., additional, Wang, S., additional, Artignan, X., additional, Juhasz-Böess, I., additional, Rody, A., additional, Ngan, R., additional, Dourleshter, F., additional, Goldberg, H., additional, Doni, L., additional, Di Costanzo, F., additional, Ferraù, F., additional, Drobniene, M., additional, Aleknavicius, E., additional, Rashid, K., additional, Costa, L., additional, de la Cruz Merino, L., additional, Garcia Saenz, J., additional, López, R., additional, Del Val Munoz, O., additional, Ozyilkan, O., additional, Azribi, F., additional, Jaafar, H., additional, Baird, R., additional, Verrill, M., additional, Beith, J., additional, Petzer, A., additional, Moreira de Andrade, J., additional, Bernstein, V., additional, Macpherson, N., additional, Rayson, D., additional, Saad Eldin, I., additional, Achille, M., additional, Augereau, P., additional, Müller, V., additional, Rasco, A., additional, Evron, E., additional, Katz, D., additional, Berardi, R., additional, Cascinu, S., additional, De Censi, A., additional, Gennari, A., additional, El-Saghir, N., additional, Ghosn, M., additional, Oosterkamp, H.M., additional, Van den Bosch, J., additional, Kukulska, M., additional, Kalinka, E., additional, Alonso, J., additional, Dalmau Portulas, E., additional, Del Mar Gordon Santiago, M., additional, Pelaez Fernandez, I., additional, Aksoy, S., additional, Altundag, K., additional, Senol Coskun, H., additional, Bozcuk, H., additional, Shparyk, Y., additional, Barraclough, L., additional, Levitt, N., additional, Panwar, U., additional, Kelly, S., additional, Rigg, A., additional, Varughese, M., additional, Castillo, C., additional, Fein, L., additional, Malik, L., additional, Stuart-Harris, R., additional, Singer, C., additional, Stoeger, H., additional, Samonigg, H., additional, Feng, J., additional, Cedeño, M., additional, Ruohola, J., additional, Berdah, J.-F., additional, Goncalves, A., additional, Orfeuvre, H., additional, Grischke, E.-M., additional, Simon, E., additional, Wagner, S., additional, Koumakis, G., additional, Papazisis, K., additional, Ben Baruch, N., additional, Fried, G., additional, Geffen, D., additional, Karminsky, N., additional, Peretz, T., additional, Cavanna, L., additional, Pedrazzioli, P., additional, Grasso, D., additional, Ruggeri, E., additional, D’Auria, G., additional, Moscetti, L., additional, Juozaityte, E., additional, Rodriguez Cid, J., additional, Roerdink, H., additional, Siddiqi, N., additional, Passos Coelho, J., additional, Arcediano Del Amo, A., additional, Garcia Garre, E., additional, García Gonzalez, M., additional, Garcia-Palomo Perez, A., additional, Herenandez Perez, C., additional, Lopez Alvarez, P., additional, Lopez De Ceballos, M.H., additional, Martínez Jañez, N., additional, Mele Olive, M., additional, McAdam, K., additional, Perren, T., additional, Dunn, G., additional, Humphreys, A., additional, Taylor, W., additional, Vera, R., additional, Kaen, L., additional, Andel, J., additional, Steger, G., additional, De Grève, J., additional, Huizing, M., additional, Hegg, R., additional, Joy, A., additional, Kuruvilla, P., additional, Sehdev, S., additional, Smiljanic, S., additional, Kütner, R., additional, Alexandre, J., additional, Grosjean, J., additional, Laplaige, P., additional, Largillier, R., additional, Maes, P., additional, Martin, P., additional, Pottier, V., additional, Christensen, B., additional, Khandan, F., additional, Lück, H.-J., additional, Zahm, D.-M., additional, Fountzilas, G., additional, Karavasilis, V., additional, Safra, T., additional, Inbar, M., additional, Ryvo, L., additional, Bonetti, A., additional, Seles, E., additional, Giacobino, A., additional, Chavarri Guerra, Y., additional, de Jongh, F., additional, van der Velden, A., additional, van Warmerdam, L., additional, Vrijaldenhoven, S., additional, Smorenburg, C.H., additional, Cavero, M., additional, Andres Conejero, R., additional, Oltra Ferrando, A., additional, Redondo Sanchez, A., additional, Ribelles Entrena, N., additional, Saura Grau, S., additional, Viñas Vilaro, G., additional, Bachmeier, K., additional, Beresford, M., additional, Butt, M., additional, Joffe, J., additional, Poole, C., additional, Woodings, P., additional, Chakraborti, P., additional, Yordi, G., additional, Woodward, N., additional, Nobre, A., additional, Luiz Amorim, G., additional, Califaretti, N., additional, Fox, S., additional, Robidoux, A., additional, Li, E., additional, Li, N., additional, Jiang, J., additional, Soria, T., additional, Padrik, P., additional, Lahdenpera, O., additional, Barletta, H., additional, Dohollou, N., additional, Genet, D., additional, Prulhiere, K., additional, Coeffic, D., additional, Facchini, T., additional, Vieillot, S., additional, Catala, S., additional, Teixeira, L., additional, Hesse, T., additional, Kühn, T., additional, Ober, A., additional, Repp, R., additional, Schröder, W., additional, Pectasides, D., additional, Bodoky, G., additional, Kahan, Z., additional, Jiveliouk, I., additional, Rosengarten, O., additional, Rossi, V., additional, Alabiso, O., additional, Pérez Martínez, M., additional, van de Wouw, A.J., additional, Smok-Kalwat, J., additional, Damasecno, M., additional, Augusto, I., additional, Sousa, G., additional, Saadein, A., additional, Abdelhafiez, N., additional, Abulkhair, O., additional, Antón Torres, A., additional, Corbellas Aparicio, M., additional, Llorente Domenech, R., additional, Florián Jerico, J., additional, Garcia Mata, J., additional, Gil Raga, M., additional, Galan Brotons, A., additional, Llombart Cussac, A., additional, Llorca Ferrandiz, C., additional, Martinez Del Prado, P., additional, Olier Garate, C., additional, Rodriguez Sanchez, C., additional, Sanchez Gomez, R., additional, Santisteban Eslava, M., additional, Soberino, J., additional, Vidal Losada Garcia, M., additional, Soto de Prado, D., additional, Torrego Garcia, J., additional, Vicente Rubio, E., additional, Garcia, M., additional, Murias Rosales, A., additional, Granstam Björneklett, H., additional, Narbe, U., additional, Jafri, M., additional, Rea, D., additional, Newby, J., additional, Jones, A., additional, Westwell, S., additional, Ring, A., additional, Alonso, I., additional, and Rodríguez, R., additional

Published
2021
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11. 203P Randomized study of single-agent metronomic versus weekly oral vinorelbine (VNR) as first-line chemotherapy in patients with HR+/HER2- advanced breast cancer

Author

Cazzaniga, M.E., primary, Martinez Jañez, N., additional, Kukielka-Budny, B.D., additional, Ulanska, M., additional, Bourgeois, H., additional, Muñoz Mateu, M., additional, Morales Murillo, S., additional, Bayo, J., additional, Cortesi, L., additional, Pinter, T., additional, Palacova, M., additional, Cherciu, N., additional, Petru, E., additional, Ettl, J., additional, De Almeida, C., additional, Raymond, R., additional, Villanova, G.R., additional, Thanh Minh, C. Ta, additional, Rodrigues, A.C.F., additional, and Freyer, G., additional

Published
2021
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12. 273P Talazoparib (TALA) for patients with germline BRCA1/2 mutated (gBRCA1/2mut) advanced breast cancer (ABC): Characteristics of patients who experienced hematologic toxicity in the phase III EMBRACA trial

Author

Hurvitz, S.A., primary, Rugo, H.S., additional, Ettl, J., additional, Martin, M., additional, Roche, H., additional, Lee, K-H., additional, Goodwin, A., additional, Usari, T., additional, Lanzalone, S., additional, Guenzel, C.A., additional, Blum, J., additional, and Litton, J.K., additional

Published
2021
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13. 272P Outcomes of patients (pts) who had received prior platinum (PP) therapy in the phase III EMBRACA trial of talazoparib (TALA) vs physician’s choice of chemotherapy (PCT) in patients with germline BRCA1/2 mutated (gBRCA1/2mut) advanced breast cancer (ABC)

Author

Martin, M., primary, Rugo, H.S., additional, Hurvitz, S.A., additional, Ettl, J., additional, Roche, H., additional, Lee, K-H., additional, Goodwin, A., additional, Usari, T., additional, Lanzalone, S., additional, Guenzel, C.A., additional, Blum, J., additional, and Litton, J.K., additional

Published
2021
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14. Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial

Author

H. Bhattacharyya, Kyung-Hun Lee, Henri Roché, Alison L. Hannah, Hope S. Rugo, Ruben G.W. Quek, Denka Markova, Johannes Ettl, Joanne L. Blum, A. Goncalves, Lida A. Mina, Wolfgang Eiermann, Miguel Martin, Yunjoo Im, Rinat Yerushalmi, Louis Fehrenbacher, Sara A. Hurvitz, and Jennifer K. Litton

Subjects
Adult, 0301 basic medicine, medicine.medical_specialty, Time Factors, Breast Neoplasms, Poly(ADP-ribose) Polymerase Inhibitors, Vinorelbine, law.invention, Young Adult, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Breast cancer, Quality of life, Randomized controlled trial, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Patient Reported Outcome Measures, Germ-Line Mutation, Aged, Aged, 80 and over, BRCA2 Protein, BRCA1 Protein, Proportional hazards model, business.industry, Cancer, Hematology, Middle Aged, medicine.disease, Chemotherapy regimen, humanities, 030104 developmental biology, Oncology, chemistry, 030220 oncology & carcinogenesis, Quality of Life, Phthalazines, Female, business, Eribulin, medicine.drug
Abstract

In the EMBRACA phase III trial, talazoparib (1 mg daily, orally) demonstrated a statistically significant improvement in PFS versus physician's choice of chemotherapy (PCT; capecitabine, eribulin, gemcitabine, or vinorelbine) in patients with HER2-negative advanced breast cancer carrying a germline BRCA1/2 mutation; we evaluated patient-reported outcomes (PROs).Patients were randomized 2 : 1 to receive talazoparib or PCT. PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks), and at the end of treatment, using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) and its breast cancer module, QLQ-BR23. Prespecified exploratory analyses included a longitudinal mixed-effect model comparing treatment arms and a time to definitive clinically meaningful deterioration (TTD) analysis carried out in the global health status/quality of life (GHS/QoL), and all functional and symptom scales from the EORTC QLQ-C30 and -BR23 questionnaires. Between-arm TTD comparisons were made using a stratified log-rank test and a Cox proportional hazards model.Baseline scores were similar between arms. Statistically significant estimated overall improvement from baseline in GHS/QoL was seen for talazoparib compared with statistically significant deterioration for PCT {3.0 [95% confidence interval (CI) 1.2, 4.8] versus -5.4 [95% CI -8.8, -2.0]; between arms, P 0.0001}. A statistically significant greater delay was observed in TTD in GHS/QoL, favoring talazoparib over PCT [hazard ratio, 0.38 (95% CI 0.26, 0.55; median, 24.3 versus 6.3 months, respectively; P 0.0001)]. A statistically significant overall change and a statistically significant delay in TTD, all favoring talazoparib, were also observed in multiple functions and symptoms.Patients who received talazoparib had significant overall improvements and significant delay in TTD in multiple cancer-related and breast cancer-specific symptoms, functions, and GHS/QoL.NCT01945775.

Published
2018
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15. 357TiP SGNLVA-002: Single arm, open-label, phase Ib/II study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

Author

Cortés, J., primary, Diab, S., additional, Basho, R.K., additional, Oliveira, M., additional, Pluard, T., additional, Alemany, C., additional, Brown-Glaberman, U., additional, Meisel, J., additional, Boni, V., additional, Sinha, R., additional, Estevez, L. García, additional, Ettl, J., additional, Kuemmel, S., additional, Sanchez, L.M. Manso, additional, Moon, Y.W., additional, Vazquez, R. Villanueva, additional, Wuerstlein, R., additional, Wang, Y., additional, Wang, Z., additional, and Han, H., additional

Published
2020
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16. 272P Outcomes of patients (pts) who had received prior platinum (PP) therapy in the phase III EMBRACA trial of talazoparib (TALA) vs physician’s choice of chemotherapy (PCT) in patients with germline BRCA1/2 mutated (gBRCA1/2mut) advanced breast cancer (ABC)

Author

Joanne L. Blum, S Hurvitz, Silvana Lanzalone, Annabel Goodwin, Jennifer K. Litton, H. Roche, Tiziana Usari, HS Rugo, K-H Lee, Johannes Ettl, M. Martin, and Carolin Guenzel

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, business.industry, Advanced breast, medicine.medical_treatment, Cancer, Hematology, medicine.disease, Germline, chemistry.chemical_compound, chemistry, Internal medicine, Medicine, Talazoparib, In patient, business
Published
2021
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17. 273P Talazoparib (TALA) for patients with germline BRCA1/2 mutated (gBRCA1/2mut) advanced breast cancer (ABC): Characteristics of patients who experienced hematologic toxicity in the phase III EMBRACA trial

Author

Silvana Lanzalone, Johannes Ettl, Carolin Guenzel, M. Martin, Joanne L. Blum, Sara A. Hurvitz, Hope S. Rugo, K-H Lee, H. Roche, Tiziana Usari, Jennifer K. Litton, and Annabel Goodwin

Subjects
Oncology, medicine.medical_specialty, business.industry, Advanced breast, Cancer, Hematology, Hematologic toxicity, medicine.disease, Germline, chemistry.chemical_compound, chemistry, Internal medicine, medicine, Talazoparib, business
Published
2021
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18. 203P Randomized study of single-agent metronomic versus weekly oral vinorelbine (VNR) as first-line chemotherapy in patients with HR+/HER2- advanced breast cancer

Author

M. Muñoz Mateu, Laura Cortesi, M. Ulanska, J. Bayo, N. Martínez Jañez, E. Petru, T. Pinter, A.C.F. Rodrigues, G.R. Villanova, J. Ettl, Marina Elena Cazzaniga, C de Almeida, S. Morales Murillo, G. Freyer, R. Raymond, N. Cherciu, B.D. Kukielka-Budny, C. Ta Thanh Minh, M. Palacova, and H. Bourgeois

Subjects
Oncology, medicine.medical_specialty, business.industry, Advanced breast, Cancer, Hematology, Vinorelbine, medicine.disease, law.invention, Randomized controlled trial, law, Internal medicine, medicine, Single agent, In patient, First line chemotherapy, business, medicine.drug
Published
2021
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19. 357TiP SGNLVA-002: Single arm, open-label, phase Ib/II study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

Author

Jane L. Meisel, Yinghui Wang, L. Manso Sánchez, Valentina Boni, Rachel Wuerstlein, Carlos Alemany, Johannes Ettl, Sami Diab, HS Han, Zejing Wang, Ursa Brown-Glaberman, L. Garcia Estevez, R. Villanueva Vazquez, S. Kuemmel, Mafalda Oliveira, J. Cortés, Reva Basho, Timothy J. Pluard, Y.W. Moon, and Rajni Sinha

Subjects
First line treatment, Oncology, medicine.medical_specialty, business.industry, Internal medicine, medicine, Phase (waves), Hematology, Pembrolizumab, Open label, business, Triple-negative breast cancer
Published
2020
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20. Patient Reported Outcomes (PRO) in patients (pts) with HER2- advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) receiving talazoparib (TALA) vs physician’s choice chemotherapy (PCT) in the EMBRACA trial: A focus on subgroups with/ without visceral disease

Author

H. Bhattacharyya, A. Gonçalves, R.G.W. Quek, Johannes Ettl, Hope S. Rugo, and Sara A. Hurvitz

Subjects
0301 basic medicine, medicine.medical_specialty, Post hoc, business.industry, Advanced breast, Stock options, Hematology, 03 medical and health sciences, Brca1 2 mutation, 030104 developmental biology, 0302 clinical medicine, Visceral disease, Oncology, 030220 oncology & carcinogenesis, Family medicine, Honorarium, Health care, Medicine, In patient, business
Abstract

Background As part of the key subgroup analyses of EMBRACA, a randomized 2:1 open-label phase 3 study (NCT01945775), improvements in PFS with TALA vs PCT were observed in both subgroups: HER2- gBRCAm ABC pts with/without visceral disease at baseline; these post hoc analyses evaluated PRO. Methods PRO was assessed on baseline, at start of each 3-week cycle, and at end of treatment, using the EORTC QLQ-C30 and breast cancer module, QLQ-BR23. Higher scores indicate better functioning/global health status (GHS)/QoL or worse symptom severity. PRO analyses performed separately in pts with/without visceral disease, for GHS/QoL, functional and symptom scales include: Overall mean change from baseline (per longitudinal repeated measures mixed-effects model) and time to definitive clinically meaningful deterioration (TTD) (per survival analysis methods). Between-arm comparisons of TTD were made using stratified log-rank test and Cox proportional hazards model. Results Baseline scores were similar between arms. A statistically significant estimated overall change from baseline in GHS/QoL favored TALA vs PCT for both subgroups with {8.8 [95%CI: (4.1, 13.5)] P Conclusions In HER2- gBRCAm ABC, TALA (vs PCT) resulted in significantly better change from baseline and delayed TTD in GHS/QoL and pain in both pts subgroups with/without visceral disease. Clinical trial identification NCT01945775. Editorial acknowledgement Editorial/writing support was provided by Chantel Cadwell, PhD, and Dena McWain at Ashfield Healthcare Communications, Middletown, CT. Legal entity responsible for the study Pfizer Inc. Funding Pfizer Inc. Disclosure J. Ettl: Honoraria (self), Advisory / Consultancy: Lily; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Eisai; Research grant / Funding (self), Travel / Accommodation / Expenses: Celgene; Honoraria (self): TEVA; Honoraria (self): AstraZeneca. R.G.W. Quek: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. H. Bhattacharyya: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. H.S. Rugo: Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Pfizer Inc.; Research grant / Funding (institution): Plexxikon; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Puma; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Pfizer Inc.; Research grant / Funding (institution): Plexxikon; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Puma. S.A. Hurvitz: Research grant / Funding (institution): Ambryx; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): BI Pharma; Research grant / Funding (institution): Biomarin; Research grant / Funding (institution): Cascadian; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Dignitana; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): Macrogenics; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Merrimack; Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: OBI Pharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Pieris; Research grant / Funding (institution): PUMA; Research grant / Funding (institution): Roche, Seattle Genetics. A. Goncalves: Travel / Accommodation / Expenses: Pfizer Inc.; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Boehringer Ingelheim.

Published
2019
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21. Next-generation DNA sequencing (NGS) results for tumours from phase II ABRAZO study of talazoparib after platinum or cytotoxic non-platinum regimens in patients (pts) with advanced breast cancer (ABC) and germline BRCA1/2 (gBRCA) mutations

Author

Audrey Mailliez, Judith Balmaña, Mark E. Robson, U. Conte, Lida A. Mina, Nicholas C. Turner, A.D. Laird, Paul Bycott, Sara A. Hurvitz, Jijumon Chelliserry, Andrew M Wardley, Hope S. Rugo, Peter A. Fasching, E-M. Grischke, Melinda L. Telli, Johannes Ettl, G.M. Frampton, and Lee A. Albacker

Subjects
education.field_of_study, business.industry, Advanced breast, Population, Stock options, Hematology, Tp53 mutation, Tumor tissue, Management, Oncology, Medicine, Non platinum, In patient, education, business, Likely pathogenic
Abstract

Background Loss-of-function mutations in genes encoding components of the homologous recombination (HR) machinery are associated with tumor sensitivity to poly (ADP-ribose) polymerase (PARP) inhibitors. In ABRAZO, the PARP inhibitor talazoparib demonstrated encouraging efficacy in gBRCA-mutated ABC, both in pts whose cancer responded to prior platinum therapy (cohort 1) and in pts who had received ≥3 prior nonplatinum chemotherapy regimens for ABC (cohort 2). Methods Baseline tumor tissue (primary or metastatic sites) from enrolled pts was sequenced using the FoundationOne CDx NGS panel. 60/84 pts (71%) in the intent-to-treat population had available tumor tissue, which could be sequenced. Mutations summarized below were known or likely pathogenic single-nucleotide variants, insertions, deletions, or rearrangements. Additional exploratory computational analyses pertinent to HR deficiency were performed, including genomic loss of heterozygosity (gLOH) and somatic-germline-zygosity assessments. Results Tumor mutations in BRCA1 and BRCA2 were detected in 29 (48%) and 28 (47%) of 60 evaluable pts (no pts exhibited mutations in both BRCA1 and BRCA2). These mutations were most commonly single-nucleotide variants (BRCA1: 12 [20%] and BRCA2: 10 [17%]) or deletions (BRCA1: 11 [18%] and BRCA2: 12 [20%]). Mutations in other genes implicated in HR were comparatively rare, with mutations in CHEK2 (2 pts), ARID1A, ATR, BARD1, BRD4, BRIP1, FANCC, and STAG2 (each in single pts) detected. In addition to BRCA1/2, genes where mutations were detected in ≥ 10% of evaluable pts included TP53 (45%) and PIK3CA (12%). TP53 mutations were more commonly observed in BRCA1-mutated than in BRCA2-mutated tumors (22/29 [76%] compared with 4/28 [14%]). Associations of genetic/genomic events with progression-free survival will be presented. Conclusions NGS of tumors from the ABRAZO study of talazoparib in patients with gBRCA-mutated ABC revealed a complex mutational landscape. Exploratory correlative analyses are ongoing and will be reported. Clinical trial identification NCT02034916. Legal entity responsible for the study Pfizer Inc. Funding Pfizer Inc. Disclosure N.C. Turner: Advisory / Consultancy, Research grant / Funding (institution): Pfizer Inc.; Advisory / Consultancy, Research grant / Funding (institution): BioMarin. A..D. Laird: Full / Part-time employment: Pfizer Inc. M.L. Telli: Advisory / Consultancy, Research grant / Funding (institution): Pfizer Inc.; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Tesaro; Advisory / Consultancy, Research grant / Funding (institution): PharmaMar; Advisory / Consultancy, Research grant / Funding (institution): Vertex; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Biothera; Research grant / Funding (institution): Calithera Biosciences; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OncoSec; Research grant / Funding (institution): Sanofi. H.S. Rugo: Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GSK; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Plexxikon; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Puma; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): MacroGenics; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Plexxikon; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Puma. A. Mailliez: Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Advisory / Consultancy, Research grant / Funding (institution): PharmaMar; Advisory / Consultancy: Vertex; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Biothera; Research grant / Funding (institution): Calithera Biosciences; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): OncoSec; Research grant / Funding (institution): Pfizer Inc. J. Ettl: Honoraria (institution), Advisory / Consultancy: Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (institution), Advisory / Consultancy: Roche; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Eisai; Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self): TEVA; Honoraria (self): AstraZeneca. J. Balmana: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZenca; Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: BMS; Research grant / Funding (institution), Travel / Accommodation / Expenses: PharMar. P.A. Fasching: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Puma; Honoraria (self), Advisory / Consultancy: Daiichi Sankyo; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Teva; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (institution), Speaker Bureau / Expert testimony: Myelo; Research grant / Funding (institution): BioNTech. S.A. Hurvitz: Research grant / Funding (institution): Ambryx; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): BI Pharma; Research grant / Funding (institution): Biomarin; Research grant / Funding (institution): Cascadian; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Dignitana; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): GSK; Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Research grant / Funding (institution): Macrogenics; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Merrimack; Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: OBI Pharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Pieris; Research grant / Funding (institution): PUMA; Research grant / Funding (institution): Roche. L.A. Albacker: Full / Part-time employment: Foundation Medicine Inc. G.M. Frampton: Full / Part-time employment: Foundation Medicine Inc. J. Chelliserry: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. P. Bycott: Research grant / Funding (self), Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. U. Conte: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. A.M. Wardley: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche. M.E. Robson: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: McKesson; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): BioMarin; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Myriad Genetics; Research grant / Funding (institution): Tesaro. All other authors have declared no conflicts of interest.

Published
2019
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22. Feasibility of quantitative sensory testing (QST) in clinical routine as a tool to evaluate chemotherapy-induced peripheral neuropathy (CIPN) amongst breast cancer patients treated with taxanes

Author

T. Tölle, D. Utpadel-Fischler, I. Ioannou, M. Kiechle, and Johannes Ettl

Subjects
Oncology, medicine.medical_specialty, Breast cancer, Chemotherapy-induced peripheral neuropathy, business.industry, Internal medicine, Quantitative sensory testing, Medicine, Hematology, business, medicine.disease, Clinical routine
Published
2019
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23. Palbociclib rechallenge in hormone receptor (HR)[+]/HER2[-] advanced breast cancer (ABC). PALMIRA trial

Author

Llombart Cussac, A., primary, Medioni, J., additional, Colleoni, M.A., additional, Ettl, J., additional, Schmid, P., additional, Macpherson, I., additional, Gligorov, J., additional, Albanell, J., additional, Bellet Ezquerra, M., additional, Fernández, A., additional, Ruiz Borrego, M., additional, Gavilá-Gregori, J., additional, Wheatley, D., additional, Zamora, P., additional, Martínez, E., additional, Sampayo, M., additional, Riva, F., additional, Malfettone, A., additional, Pérez-García, J.M., additional, and Cortés, J., additional

Published
2019
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24. Next-generation DNA sequencing (NGS) results for tumours from phase II ABRAZO study of talazoparib after platinum or cytotoxic non-platinum regimens in patients (pts) with advanced breast cancer (ABC) and germline BRCA1/2 (gBRCA) mutations

Author

Turner, N.C., primary, Laird, A.D., additional, Telli, M.L., additional, Rugo, H.S., additional, Mailliez, A., additional, Ettl, J., additional, Grischke, E.-M., additional, Mina, L.A., additional, Balmaña, J., additional, Fasching, P.A., additional, Hurvitz, S.A., additional, Albacker, L.A., additional, Frampton, G.M., additional, Chelliserry, J., additional, Bycott, P., additional, Conte, U., additional, Wardley, A.M., additional, and Robson, M.E., additional

Published
2019
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28. RESCUE: Reaching for evidence-based chemotherapy use in endocrine sensitive breast cancer - A prospective non-interventional study on risk assessment by the endopredict test and long-term patient outcome in early luminal breast cancer

Author

Ettl, J., primary, Blohmer, J.-U., additional, Denkert, C., additional, Beier, L., additional, Klein, E., additional, Neuser, P., additional, Keller, M., additional, Untch, M., additional, Wittenberg, M., additional, and Kiechle, M., additional

Published
2019
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30. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bachelot, T., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Bondarenko, I., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, du Toit, Y., additional, Easton, V., additional, Lindegger, N., additional, Miles, D., additional, Bouzid, Kamel, additional, Campone, Mario, additional, Coudert, Bruno, additional, Nowecki, Zbigniew, additional, Errihani, Hassan, additional, Dalenc, Florence, additional, Ferreira, Ana, additional, Mano, Max, additional, Ricci, Francesco, additional, Kalofonos, Haralabos, additional, Andreetta, Claudia, additional, Montemurro, Filippo, additional, Barrett, Sophie, additional, Zhang, Qingyuan, additional, Mavroudis, Dimitris, additional, Matus, Juan, additional, Beato, Carlos, additional, Hu, Xichun, additional, Gaafar, Rabab, additional, Abdel Azeem, Hamdy, additional, Perrin, Christophe, additional, Ettl, Johannes, additional, Lang, Istvan, additional, Verma, Sunil, additional, Li, Huiping, additional, Brain, Etienne, additional, Hoffmann, Oliver, additional, Cariello, Anna, additional, Tondini, Carlo, additional, Altwegeiri, Taher, additional, Loman, Niklas, additional, Lux, Michael, additional, Frassoldati, Antonio, additional, Aziz, Zeba, additional, Salas, Fernando, additional, Streb, Joanna, additional, Wronski, Andrzej, additional, Menjón Beltrán, Salomón, additional, Cicin, Irfan, additional, Schmid, Peter, additional, Laing, Robert, additional, Tong, Zhongsheng, additional, Boer, Katalin, additional, Juhasz, Balazs, additional, Gianni, Luca, additional, Curigliano, Giuseppe, additional, Juarez, Alejandro, additional, Susnjar, Snezana, additional, Matos, Erika, additional, Uslu, Ruchan, additional, Wildiers, Hans, additional, Cruz, Marcelo, additional, Bourgeois, Hugues, additional, von Schumann, Raquel, additional, Stemmer, Salomón, additional, Vásquez, Flavia Morales, additional, Dominguez, Adriana, additional, Wojtukiewicz, Marek, additional, Trifunovic, Jasna, additional, Illarramendi, Jose Juan, additional, Garcia, Laura, additional, Peron, Yann Izarzugaza, additional, Echarri, Maria Jose, additional, Voitko, Natliia, additional, Wheatley, Duncan, additional, Waters, Simon, additional, De Boer, Richard, additional, Jerusalem, Guy, additional, Cocquyt, Véronique, additional, Barrios, Carlos, additional, Panasci, Lawrence, additional, Mattson, Johanna, additional, Tanner, Minna, additional, Gozy, Michel, additional, Vasilopoulos, Georgios, additional, Revesz, Janos, additional, Latini, Luciano, additional, Gridelli, Cesare, additional, Lazaro, Jesus, additional, Gonzalez, Antonio, additional, Barnadas Molins, Agusti, additional, Martinez, Eduardo, additional, Alarcón, Jesús, additional, Arance, Ana, additional, Klint, Leif, additional, Kovalyov, Oleksiy, additional, Baird, Richard, additional, Yeo, Belinda, additional, McCarthy, Nicole, additional, Greil, Richard, additional, Wang, Shusen, additional, Artignan, Xavier, additional, Augereau, Paule, additional, Juhasz-Boess, Ingolf, additional, Ngan, Roger, additional, Goldberg, Hadassah, additional, Di Costanzo, Francesco, additional, Ferraù, Francesco, additional, Aleknavicius, Eduardas, additional, Rashid, Kamran, additional, Costa, Luís, additional, Angel Garcia, Jose, additional, de la Cruz, Luis Ruiz, additional, López López, Rafael, additional, Del Val, Olga, additional, Ozyilkan, Ozgur, additional, Azribi, Fathi, additional, Verrill, Mark, additional, Turner, Nicholas, additional, Beith, Jane, additional, Petzer, Andreas, additional, Andrade, Jurandyr, additional, Bernstein, Vanessa, additional, Rayson, Daniel, additional, Saad Eldin, Ibtessam, additional, Achille, Mihaëla, additional, Mueller, Volkmar, additional, Gennari, Alessandra, additional, Cascinu, Stefano, additional, Ghosn, Marwan, additional, El-Saghir, Nagi, additional, Van den Bosch, Joan, additional, Oosterkamp, Rianne, additional, Kukulska, Monika, additional, Pelaez, Ignacio, additional, Hernandez, Carolina, additional, del Mar Gordon, Maria, additional, Dalmau, Elsa, additional, Alonso, Jose Luis, additional, Aksoy, Sercan, additional, Coskun, Hasan Senol, additional, Shparyk, Yaroslav, additional, Varughese, Mohini, additional, Panwar, Udaiveer, additional, Barraclough, Lisa, additional, Levitt, Nicola, additional, Hicks, Jonathan, additional, Rigg, Anna, additional, Allen, Mark, additional, Castillo, Cecila, additional, Fein, Luis Enrique, additional, Stuart-Harris, Robin, additional, Singer, Christian, additional, Stoeger, Herbert, additional, Smiljanic, Sasha, additional, Feng, Jifeng, additional, Cedeño, Miguel, additional, Berdah, Jean Francois, additional, Orfeuvre, Hubert, additional, Goncalves, Anthony, additional, Grischke, Eva-Maria, additional, Simon, Eike, additional, Wagner, Steffen, additional, Efremidou, Anna, additional, Papazisis, Konstantinos, additional, Evron, Ella, additional, Inbar, Moshe, additional, Baruch, Noa Ben, additional, Geffen, David, additional, Karminsky, Natalya, additional, Ruggeri, Enzo Maria, additional, Luigi, Cavanna, additional, Grasso, Donatella, additional, Juozaityte, Elona, additional, Rafael Rodriguez Cid, Jeronimo, additional, Roerdink, Henk, additional, Siddiqi, Neelum, additional, Passos Coelho, José Luís, additional, Garre, Elisa Garcia, additional, Garcia, Andres, additional, Martínez Jañez, Noelia, additional, Lopez Ceballos, Maria Helena, additional, Mele, Mireia, additional, García, María, additional, Arcediano, Alberto, additional, McAdam, Karen, additional, Perren, Timothy, additional, Taylor, Wendy, additional, Humphreys, Alison, additional, Vera, Raul, additional, Kaen, Luis Alberto, additional, Steger, Günther, additional, Andel, Johannes, additional, de Grève, Jacques, additional, Huizing, Manon, additional, Hegg, Roberto, additional, Joy, Anil, additional, Sehdev, Sandeep, additional, Kütner, Riina, additional, Ruohola, Johanna, additional, Dohollou, Nadine, additional, Grosjean, Jessica, additional, Laplaige, Philippe, additional, Largillier, Rémy, additional, Martin, Philippe, additional, Pottier, Virginie, additional, Alexandre, Jerome, additional, Christensen, Bernd, additional, Zahm, Dirk-Michael, additional, Khandan, Fariba, additional, Lueck, Hans-Joachim, additional, Fountzilas, Georgios, additional, Fried, Georgeta, additional, Giacobino, Alice, additional, Bonetti, Andrea, additional, Guerra, Yanin Chavarri, additional, Van Warmerdam, Laurens, additional, Van der Velden, Annette, additional, Vrijaldenhoven, Suzan, additional, de Jongh, Felix, additional, Cavero, Milagros, additional, Andres Conejero, Raquel, additional, Murias, Adolfo, additional, Saura, Salvador, additional, Oltra, Amparo, additional, Redondo, Andres, additional, Ribelles, Nuria, additional, Bachmeier, Kilian, additional, Joffe, Johnathan, additional, Chakraborti, Prabir, additional, Beresford, Mark, additional, Butt, Mohammad, additional, Poole, Christopher, additional, Yordi, Gassan, additional, Woodward, Natasha, additional, Amorim, Gilberto, additional, Califaretti, Nadia, additional, Fox, Susan, additional, Robidoux, Andre, additional, Li, NanLi, additional, Li, Nenxiao, additional, Jiang, Jun, additional, Soria, Tannia, additional, Padrik, Peeter, additional, Saarni, Outi, additional, Genet, Dominique, additional, Catala, Stéphanie, additional, Barletta, Hugues, additional, Teixeira, Luis, additional, Facchini, Thomas, additional, Hesse, Tobias, additional, Kühn, Thorsten, additional, Ober, Angelika, additional, Repp, Roland, additional, Schroeder, Willibald, additional, Pectasides, Dimitrios, additional, Bodoky, Gyorgy, additional, Kahan, Zsuzsanna, additional, Jiveliouk, Irina, additional, Rosengarten, Ora, additional, Alabiso, Oscar, additional, Perez, Mario, additional, Van de Wouw, Yes, additional, Smok-Kalwat, Jolanta, additional, Damasceno, Margarida, additional, Sousa, Gabriela, additional, Abulkhair, Omalkhair, additional, Antón Torres, Antonio, additional, Martinez, Maria Purificación, additional, Garcia Mata, Jesús, additional, Jesús Florián Jerico, Marta Santisteban, additional, Llombart, Antonio, additional, Sanchez, Rosa, additional, Torrego, Juan Carlos, additional, Garate, Clara Olier, additional, Rodriguez, Cesar, additional, Llorente, Rosa, additional, de Prado, Diego Soto, additional, Cortés, Javier, additional, Llorca, Cristina, additional, Galán, Antonio, additional, Viñas Villaro, Gemma, additional, Narbe, Ulrik, additional, Bjömeklett, Helena Granstam, additional, Westwell, Sarah, additional, Newby, Jackie, additional, Jafri, Mariam, additional, Rodríguez, Robinson, additional, and Alonso, Isabel, additional

Published
2019
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31. Palbociclib rechallenge in hormone receptor (HR)[+]/HER2[-] advanced breast cancer (ABC). PALMIRA trial

Author

Eduardo Martínez, M. Bellet Ezquerra, Iain R. Macpherson, F. Riva, Jose Perez-Garcia, J. Gavilá-Gregori, Duncan Wheatley, Joan Albanell, M.A. Colleoni, M. Ruiz Borrego, J. Medioni, A. Fernández, Johannes Ettl, Peter Schmid, Joseph Gligorov, Miguel Sampayo, Andrea Malfettone, A. Llombart Cussac, Pilar Zamora, and J. Cortes

Subjects
medicine.medical_specialty, business.industry, Advanced breast, Endocrine therapy, Stock options, Hematology, Palbociclib, Clinical trial, Regimen, Oncology, Bone lesion, Family medicine, Medicine, Progression-free survival, business
Abstract

Background The combination of a CDK4/6 inhibitor (CDK4/6i) with letrozole (LET) or fulvestrant (FUL) is the most active first–line (1L) treatment for patients (pts) with HR[+]/HER2[-] ABC. Although endocrine sensitivity persists beyond progression, preliminary findings suggest more adaptive resistance mechanisms to endocrine therapy (ET) than to CDK4/6i. At present, there are no data about prolonging CDK4/6 blockade beyond progression on a CDK4/6i. The aim of this study is to determine whether palbociclib rechallenge combined with second–line ET upon progression to a prior palbociclib–based therapy will improve progression–free survival (PFS) over ET alone in HR[+]/HER2[-] ABC pts. Trial design This is an international, open–label, randomized phase II trial. A total of 198 pts will be randomized (2:1) to palbociclib plus ET (LET or FUL) or ET alone, until progressive disease (PD) or unacceptable toxicity. Pts will be stratified by 1L ET and presence of visceral metastasis. Main selection criteria include: (1) Pre– and post–menopausal women with HR[+]/HER2[-] ABC; (2) Evidence of PD on a 1L combination of palbociclib plus LET or FUL after obtaining clinical benefit (secondary resistance); (3) Pts relapsing on or within the first year of a palbociclib–based adjuvant regimen; (4) Measurable and biopsable disease or non–measurable disease with bone lesion. The primary objective is to assess PFS of palbociclib plus ET versus ET alone. The 1st co-primary endpoint is the PFS in the combination arm only. If this objective is achieved, we will compare PFS between the two arms (2nd co-primary endpoint). With 128 events, the 1st and 2nd analyses have an 80% power to detect a 1.4–month (hazard ratio [HR]=0.74) or 2.74–month (HR = 0.6) increase over 4–month median PFS for ET arm, respectively. The nominal alpha level is 5% for two-sided log-rank tests. Secondary objectives evaluate: Safety–related outcomes, objective response rate, 6–month clinical benefit rate, overall survival, quality of life, and time to first chemotherapy. Exploratory objectives include: Correlation between the intrinsic molecular subtypes and efficacy/safety findings, and identification of new predictive markers. Clinical trial identification NCT03809988. First Posted: January 18, 2019. Legal entity responsible for the study Medica Scientia Innovation Research (MedSIR). Funding Pfizer S.L.U. Disclosure A. Llombart Cussac: Honoraria (institution), Advisory / Consultancy: Roche, GlaxoSmithKline, Novartis, Celgene, Eisai, AstraZeneca; Research grant / Funding (institution): GlaxoSmithKline, Sanofi, Puma Biotechnology; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). P. Schmid: Advisory / Consultancy: Pfizer, AstraZeneca, Novartis, Merck, Boehringer Ingelheim, Bayer, Eisai, Celgene, Puma; Research grant / Funding (institution): AstraZeneca, Genentech, Roche, Oncogenex, Novartis, Astellas; Spouse / Financial dependant, Spouse is consulting for Genentech/Roche: Genentech/Roche. I. Macpherson: Honoraria (self): Celldex, Daiichi Sankyo, Eisai, Genomic Health, Novartis, Pfizer, Roche; Travel / Accommodation / Expenses: Eisai, Roche. J. Gligorov: Advisory / Consultancy: Daichi, EISAI, Genomic Health, Ipsen, Macrogenics, MSD, Novartis, Onxeo, Pfizer, Roche Genentech; Travel / Accommodation / Expenses: EISAI, Genomic Health, MSD, Novartis, Pfizer, Roche Genentech; Non-remunerated activity/ies: Daichi, EISAI, Genomic Health, Immunomedics, Novartis, Pfizer, Roche Genentech. M. Sampayo: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). F. Riva: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). A. Malfettone: Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). J.M. Perez-Garcia: Advisory / Consultancy: Roche, Lilly; Full / Part-time employment: Medica Scientia Innovation Research (MedSIR). J. Cortes: Advisory / Consultancy: Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex; Honoraria (institution): Roche, Novartis, Celgene, Eisai, Pfizer, Samsung; Research grant / Funding (institution): Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck SharpD Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors: Medica Scientia Innovation Research (MedSIR). All other authors have declared no conflicts of interest.

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2019
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32. RESCUE: Reaching for evidence-based chemotherapy use in endocrine sensitive breast cancer - A prospective non-interventional study on risk assessment by the endopredict test and long-term patient outcome in early luminal breast cancer

Author

Marion Kiechle, P. Neuser, J-U Blohmer, Carsten Denkert, L Beier, M. Wittenberg, Evelyn Klein, M. Keller, Michael Untch, and Johannes Ettl

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, Evidence-based practice, business.industry, medicine.medical_treatment, Hematology, medicine.disease, Chemotherapy regimen, Breast cancer, Internal medicine, Non interventional, Medicine, Endocrine system, business, Risk assessment
Published
2019
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33. Impact of objective response (OR) on patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 (gBRCA) mutation in the phase III EMBRACA trial

Author

R.G.W. Quek, H. Bhattacharyya, PA Fasching, Hope S. Rugo, Johannes Ettl, and Sara A. Hurvitz

Subjects
Oncology, medicine.medical_specialty, business.industry, Advanced breast, Brca1 protein, Cancer, Hematology, medicine.disease, Germline, Breast cancer, Internal medicine, Mutation (genetic algorithm), medicine, In patient, business, Objective response
Published
2019
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34. Hospitalization and supportive care medication (SCM) utilisation in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) in EMBRACA

Author

Sara A. Hurvitz, Hope S. Rugo, Iulia Cristina Tudor, R.G.W. Quek, A. Gonçalves, and Johannes Ettl

Subjects
Oncology, Brachial Plexus Neuritis, medicine.medical_specialty, business.industry, Advanced breast, Cancer, Hematology, medicine.disease, Germline, Brca1 2 mutation, Breast cancer, Internal medicine, Mutation (genetic algorithm), Medicine, In patient, business
Published
2019
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36. EMBRACA: Efficacy and safety in comparing talazoparib (TALA) with physician's choice of therapy (PCT) in patients (pts) with advanced breast cancer (aBC) and a germline BRCA mutation (gBRCAm); BRCA1/BRCA2 subgroup analysis

Author

Gonçalves, A., primary, Eiermann, W., additional, Rugo, H.S., additional, Ettl, J., additional, Hurvitz, S.A., additional, Yerushalmi, R., additional, Martín, M., additional, Al-Adhami, M., additional, Tudor, I.C., additional, Blum, J.L., additional, Hannah, A.L., additional, and Litton, J.K., additional

Published
2018
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37. EMBRACA: Comparison of efficacy and safety of talazoparib (TALA) and physician's choice of therapy (PCT) in patients (pts) with advanced breast cancer (aBC), a germline BRCA1/2 mutation (gBRCAm), and prior platinum treatment

Author

Martín, M., primary, Eiermann, W., additional, Rugo, H.S., additional, Ettl, J., additional, Hurvitz, S.A., additional, Gonçalves, A., additional, Yerushalmi, R., additional, Markova, D., additional, Tudor, I.C., additional, Blum, J.L., additional, Hannah, A.L., additional, and Litton, J.K., additional

Published
2018
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38. EMBRACA: Comparison of efficacy and safety of talazoparib (TALA) and physician's choice of therapy (PCT) in patients (pts) with advanced breast cancer (aBC), a germline BRCA1/2 mutation (gBRCAm), and prior platinum treatment

Author

Wolfgang Eiermann, Iulia Cristina Tudor, A. Gonçalves, Denka Markova, Sara A. Hurvitz, Alison L. Hannah, Hope S. Rugo, Johannes Ettl, M. Martin, Joanne L. Blum, Jennifer K. Litton, and Rinat Yerushalmi

Subjects
Oncology, medicine.medical_specialty, business.industry, Advanced breast, Cancer, Hematology, medicine.disease, Germline, 03 medical and health sciences, Brca1 2 mutation, chemistry.chemical_compound, 0302 clinical medicine, chemistry, Internal medicine, Medicine, Talazoparib, In patient, 030212 general & internal medicine, business, 030217 neurology & neurosurgery
Published
2018
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39. EMBRACA: Efficacy and safety in comparing talazoparib (TALA) with physician's choice of therapy (PCT) in patients (pts) with advanced breast cancer (aBC) and a germline BRCA mutation (gBRCAm); BRCA1/BRCA2 subgroup analysis

Author

Hope S. Rugo, Wolfgang Eiermann, Iulia Cristina Tudor, Joanne L. Blum, Jennifer K. Litton, Johannes Ettl, M. Al-Adhami, M. Martin, A. Gonçalves, Rinat Yerushalmi, Alison L. Hannah, and Sara A. Hurvitz

Subjects
Oncology, medicine.medical_specialty, business.industry, Advanced breast, BRCA mutation, Cancer, Subgroup analysis, Hematology, medicine.disease, 030226 pharmacology & pharmacy, Brca1 brca2, Germline, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, chemistry, 030220 oncology & carcinogenesis, Internal medicine, medicine, Talazoparib, In patient, business
Published
2018
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40. Patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer and a germline BRCA1/2 mutation (gBRCAm) receiving talazoparib (TALA) vs physician’s choice chemotherapy treatment (PCT): A focus on the EMBRACA triple negative (TNBC) subpopulation

Author

Sara A. Hurvitz, Johannes Ettl, H. Bhattacharyya, Hope S. Rugo, R.G.W. Quek, Alison L. Hannah, and Jennifer K. Litton

Subjects
Oncology, Chemotherapy, medicine.medical_specialty, business.industry, Advanced breast, medicine.medical_treatment, Cancer, Hematology, medicine.disease, Germline, 03 medical and health sciences, chemistry.chemical_compound, Brca1 2 mutation, 0302 clinical medicine, chemistry, Internal medicine, medicine, Talazoparib, In patient, 030212 general & internal medicine, business, Triple negative, 030217 neurology & neurosurgery
Published
2018
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41. Impact of prior treatment on palbociclib plus letrozole (P+L) efficacy and safety in patients (pts) with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2–) first-line advanced breast cancer (ABC): A PALOMA-2 subgroup analysis

Author

Finn, R.S., primary, Gelmon, K.A., additional, Ettl, J., additional, Asselah, J., additional, Castrellon, A., additional, Ruiz Simón, A., additional, Joy, A.A., additional, Lu, D., additional, Gauthier, E.R., additional, Mori, A., additional, Rugo, H.S., additional, and Diéras, V., additional

Published
2017
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42. PALOMA-2: Neutropenia (NP) patterns in patients (Pts) with estrogen receptor−positive (ER+)/human epidermal growth factor receptor 2−negative (HER2–) first-line advanced breast cancer (ABC) receiving palbociclib + letrozole (P+L)

Author

Diéras, V., primary, Harbeck, N., additional, Joy, A.A., additional, Gelmon, K.A., additional, Ettl, J., additional, Verma, S., additional, Lu, D., additional, Gauthier, E.R., additional, Schnell, P., additional, Mori, A., additional, Rugo, H.S., additional, and Finn, R.S., additional

Published
2017
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45. 314P - Next-generation DNA sequencing (NGS) results for tumours from phase II ABRAZO study of talazoparib after platinum or cytotoxic non-platinum regimens in patients (pts) with advanced breast cancer (ABC) and germline BRCA1/2 (gBRCA) mutations

Author

Turner, N.C., Laird, A.D., Telli, M.L., Rugo, H.S., Mailliez, A., Ettl, J., Grischke, E.-M., Mina, L.A., Balmaña, J., Fasching, P.A., Hurvitz, S.A., Albacker, L.A., Frampton, G.M., Chelliserry, J., Bycott, P., Conte, U., Wardley, A.M., and Robson, M.E.

Published
2019
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50. PALOMA-2: Neutropenia (NP) patterns in patients (Pts) with estrogen receptor−positive (ER+)/human epidermal growth factor receptor 2−negative (HER2–) first-line advanced breast cancer (ABC) receiving palbociclib + letrozole (P+L)

Author

Patrick Schnell, S. Verma, Véronique Diéras, Richard S. Finn, Anil A. Joy, D. Lu, Nadia Harbeck, Hope S. Rugo, Karen A. Gelmon, Johannes Ettl, A. Mori, and Eric Gauthier

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, business.industry, Advanced breast, Letrozole, Estrogen receptor, Cancer, Hematology, Palbociclib, Neutropenia, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Breast cancer, 030220 oncology & carcinogenesis, Internal medicine, medicine, business, Human Epidermal Growth Factor Receptor 2, medicine.drug
Published
2017
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