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1. Capivasertib and fulvestrant for patients with hormone receptor-positive advanced breast cancer: characterization, time course, and management of frequent adverse events from the phase III CAPItello-291 study

Author

Rugo, H.S., Oliveira, M., Howell, S.J., Dalenc, F., Cortes, J., Gomez, H.L., Hu, X., Jhaveri, K.L., Krivorotko, P., Loibl, S., Morales Murillo, S., Nowecki, Z., Okera, M., Park, Y.H., Sohn, J., Toi, M., Iwata, H., Yousef, S., Zhukova, L., Logan, J., Twomey, K., Khatun, M., D’Cruz, C.M., and Turner, N.C.

Published
2024
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2. 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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3. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results

Author

Pivot, X., Bondarenko, I., Nowecki, Z., Dvorkin, M., Trishkina, E., Ahn, J.-H., Im, S.-A., Sarosiek, T., Chatterjee, S., Wojtukiewicz, M.Z., Shparyk, Y., Moiseyenko, V., Bello, M., III, Semiglazov, V., Lee, Y., and Lim, J.

Published
2018
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4. VP3-2023: Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2- early breast cancer (EBC)

Author

Fasching, P.A., primary, Slamon, D., additional, Nowecki, Z., additional, Kukielka-Budny, B.D., additional, Stroyakovskiy, D., additional, Yardley, D., additional, Huang, C., additional, Chan, A., additional, Chia, S., additional, Martin, M., additional, Rugo, H.S., additional, Loi, S., additional, Hurvitz, S.A., additional, Untch, M., additional, Afenjar, K., additional, Fresco, R., additional, Danyliv, A., additional, Ferrusi, I., additional, Li, Z., additional, and Hortobagyi, G.N., additional

Published
2023
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5. 211MO Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase II, randomised, open-label acelERA BC study

Author

Martin Jimenez, M., primary, Lim, E., additional, Chavez Mac Gregor, M., additional, Bardia, A., additional, Wu, J., additional, Zhang, Q., additional, Nowecki, Z., additional, Cruz, F., additional, Safin, R., additional, Kim, S-B., additional, Schem, C., additional, Montero, A., additional, Khan, S., additional, Bandyopadhyay, R., additional, Shivhare, M., additional, Patre, M., additional, Martinalbo, J., additional, Roncoroni, L., additional, Pérez-Moreno, P.D., additional, and Sohn, J., additional

Published
2022
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8. 166MO Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from BEGONIA, a phase Ib/II study

Author

Schmid, P., primary, Jung, K.H., additional, Wysocki, P.J., additional, Jassem, J., additional, Ma, C.X., additional, Fernandes, R., additional, Huisden, R., additional, Stewart, R., additional, Vukovic, P., additional, Tablante Nunes, A., additional, and Nowecki, Z., additional

Published
2022
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9. 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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10. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt A, Garber J, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber R, de Azambuja E, Fielding A, Balmana J, Domchek S, Gelmon K, Hollingsworth S, Korde L, Linderholm B, Bandos H, Senkus E, Suga J, Shao Z, Pippas A, Nowecki Z, Huzarski T, Ganz P, Lucas P, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger G, Costantino J, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani S, Yothers G, Campbell C, Geyer C, OlympiA Clinical Trial Steering, and OlympiA Clinical Trial Steering Committee and Investigators

Abstract

BACKGROUND Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021

12. Final results from PERUSE, a global study of pertuzumab (P), trastuzumab (H) and investigator’s chosen taxane as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC)

Author

Schneeweiss, A, additional, Miles, D, additional, Ciruelos, E, 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, du Toit, Y, additional, Klingbiel, D, additional, Revelant, V, additional, and Bachelot, T, additional

Published
2021
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13. 46P Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) plus chemotherapy in HER2-positive early breast cancer (EBC): Safety results from the adjuvant phase of the randomised, open-label, multicentre phase III (neo)adjuvant FeDeriCa study

Author

Im, S-A., primary, Tan, A.R., additional, Mattar, A., additional, Colomer, R., additional, Stroyakovskii, D., additional, Nowecki, Z., additional, De Laurentiis, M., additional, Pierga, J-Y., additional, Jung, K.H., additional, Schem, C., additional, Aguila, C., additional, Badovinac Crnjevic, T., additional, Heeson, S., additional, Shivhare, M., additional, Alexandrou, A., additional, Restuccia, E., additional, and Jackisch, C., additional

Published
2021
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15. LBA12 PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer

Author

Mayer, E.L., primary, Gnant, M.I., additional, DeMichele, A., additional, Martin, M., additional, Burstein, H., additional, Prat, A., additional, Rubovszky, G., additional, Miller, K.D., additional, Pfeiler, G., additional, Winer, E.P., additional, Zdenkowski, N., additional, Anderson, D., additional, Nowecki, Z., additional, Loibl, S., additional, Fohler, H., additional, Metzger, O., additional, Fumagalli, D., additional, Puyana Theall, K., additional, Fesl, C., additional, and Dueck, A., additional

Published
2020
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16. 288P Final results from PERUSE, a global study of pertuzumab (P), trastuzumab (H) and investigator’s chosen taxane as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC)

Author

Miles, D.W., primary, Ciruelos, E.M., 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.M., additional, Merot, J.L., additional, du Toit, Y., additional, Klingbiel, D., additional, Revelant, V., additional, and Bachelot, T., additional

Published
2020
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17. 283MO Ipatasertib (IPAT) + paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered hormone receptor-positive (HR+) HER2-negative advanced breast cancer (aBC): Primary results from Cohort B of the IPATunity130 randomised phase III trial

Author

Turner, N., primary, Dent, R., additional, O'Shaughnessy, J., additional, Kim, S-B., additional, Isakoff, S., additional, Barrios, C.H., additional, Saji, S., additional, Bondarenko, I., additional, Nowecki, Z., additional, Lian, Q., additional, Reilly, S-J., additional, Hinton, H., additional, Wongchenko, M., additional, Mani, A., additional, and Oliveira, M., additional

Published
2020
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21. a single-centre experience

Author

Kunkiel, M., Maczkiewicz, M., Jagiełło-Gruszfeld, A., and Nowecki, Z.

Subjects
sarcoma of the chest wall, Breast cancer, angiosarcoma, treatment, soft tissue sarcoma, neoplasms, digestive system diseases
Abstract

Angiosarcomas of the breast are rare parenchymal malignancies of the chest wall. Surgery is the main treatment modality with chemotherapy and radiotherapy used in case of recurrence. With generally unfavourable prognosis and lack of clear treatment guidelines due to its rarity and scarcity of available data, angiosarcoma of the breast is a challenging clinical situation for both oncologist and patient. We present here the results of a series of 11 consecutive primary angiosarcoma cases treated at our institute between 2000 and 2015.

Published
2018
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28. One-year safety, immunogenicity, and survival results from a phase III study comparing SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment

Author

Pivot, X., primary, Bondarenko, I.M., additional, Nowecki, Z., additional, Dvorkin, M., additional, Trishkina, E., additional, Ahn, J.H., additional, Vinnyk, Y., additional, Im, S-A., additional, Sarosiek, T., additional, Chatterjee, S., additional, Wojtukiewicz, M., additional, Moiseyenko, V., additional, Shparyk, Y., additional, Bello III, M., additional, Semiglazov, V., additional, Younju, L., additional, and Lim, J., additional

Published
2017
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34. 153PD - One-year safety, immunogenicity, and survival results from a phase III study comparing SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment

Author

Pivot, X., Bondarenko, I.M., Nowecki, Z., Dvorkin, M., Trishkina, E., Ahn, J.H., Vinnyk, Y., Im, S-A., Sarosiek, T., Chatterjee, S., Wojtukiewicz, M., Moiseyenko, V., Shparyk, Y., Bello III, M., Semiglazov, V., Younju, L., and Lim, J.

Published
2017
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36. Ribociclib plus Endocrine Therapy in Early Breast Cancer.

Author

Slamon, D., Lipatov, O., Nowecki, Z., McAndrew, N., Kukielka-Budny, B., Stroyakovskiy, D., Yardley, D. A., Huang, C.-S., Fasching, P. A., Crown, J., Bardia, A., Chia, S., Im, S.-A., Ruiz-Borrego, M., Loi, S., Xu, B., Hurvitz, S., Barrios, C., Untch, M., and Moroose, R.

Abstract

BACKGROUND Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear. METHODS In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy. RESULTS As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P=0.003). Secondary end points -- distant disease-free survival and recurrence-free survival -- also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals. CONCLUSIONS Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.) [ABSTRACT FROM AUTHOR]

Published
2024
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37. The outcomes of patients with metastatic/inoperable gastrointestinal stromal tumors (GIST) treated with imatinib : an interim multicenter analysis of Polish Clinical GIST Registry

Author

Ruka, W., Piotr Rutkowski, Nowecki, Z., Osuch, C., Starosławska, E., Rozmiarek, A., Krawczyk, M., Nyckowski, P., Błasińska-Morawiec, M., Jagiełło-Gruszfeld, A., Góźdź, S., Nasierowska-Guttmejer, A., Grzesiakowska, U., Utracka-Hutka, B., and Michej, W.

Subjects
imatinib, wyniki leczenia, clinical outcome, nowotwory podścieliskowe przewodu pokarmowego, gastrointestinal stromal tumor
Published
2005

42. Long-term follow-up of patients with minimal sentinel node tumor burden (< 0.1mm) according to Rotterdam criteria: A study of the EORTC Melanoma Group

Author

van Akkooi, A. C., primary, Rutkowski, P., additional, van der Ploeg, I. M., additional, Voit, C. A., additional, Hoekstra, H. J., additional, Nieweg, O. E., additional, Schäfer-Hesterberg, G., additional, Nowecki, Z. I., additional, de Wilt, J. H., additional, and Eggermont, A. M., additional

Published
2009
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49. The criteria of aggressiveness and other prognostic factors for predicting relapses of primary tumors and imatinib (IM) treatment outcomes in advanced KIT immunopositive gastrointestinal stromal tumors (GIST): A report of the Polish Clinical GIST Registry (PCGR)

Author

Rutkowski, P., primary, Nowecki, Z. I., additional, Michej, W., additional, Debiec-Rychter, M., additional, Limon, J., additional, Siedlecki, J. A., additional, Kakol, M., additional, Gluszek, S., additional, Osuch, C., additional, and Ruka, W., additional

Published
2006
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50. The value of multi-marker reverse transcriptase-polymerase chain reaction (MM RT-PCR) assay in lymphatic drainage (LY) and peripheral blood (BL) for molecular staging of melanoma patients (pts) after lymph node dissection (LND)

Author

Ruka, W., primary, Nowecki, Z. I., additional, Rutkowski, P., additional, Kulik, J., additional, Lorenc, E., additional, Nasierowska-Guttmejer, A., additional, Zurawski, Z., additional, Zdzienicki, M., additional, and Siedlecki, J. A., additional

Published
2006
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