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1. Early prediction of endocrine responsiveness in ER+/HER2-negative metastatic breast cancer (MBC): pilot study with 18F-fluoroestradiol (18F-FES) CT/PET

Author

Malagutti, Bianca, Dib, Bassam, Branni, Carmen, D’Amico, Mauro, Provinciali, Nicoletta, Corradengo, Davide, Fiz, Francesco, Iacozzi, Massimiliano, Rocca, Andrea, Gennari, A., Brain, E., De Censi, A., Nanni, O., Wuerstlein, R., Frassoldati, A., Cortes, J., Rossi, V., Palleschi, M., Alberini, J.L., Matteucci, F., Piccardo, A., Sacchetti, G., Ilhan, H., D’Avanzo, F., Ruffilli, B., Nardin, S., Monti, M., Puntoni, M., Fontana, V., Boni, L., and Harbeck, N.

Published
2024
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2. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with early breast cancer

Author

Park, K.H., Loibl, S., Sohn, J., Park, Y.H., Jiang, Z., Tadjoedin, H., Nag, S., Saji, S., Md. Yusof, M., Villegas, E.M.B., Lim, E.H., Lu, Y.-S., Ithimakin, S., Tseng, L.-M., Dejthevaporn, T., Chen, T.W.-W., Lee, S.C., Galvez, C., Malwinder, S., Kogawa, T., Bajpai, J., Brahma, B., Wang, S., Curigliano, G., Yoshino, T., Kim, S.-B., Pentheroudakis, G., Im, S.-A., Andre, F., Ahn, J.B., and Harbeck, N.

Published
2024
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5. Prognostic value of HER2DX in early-stage HER2-positive breast cancer: a comprehensive analysis of 757 patients in the Sweden Cancerome Analysis Network—Breast dataset (SCAN-B)

Author

Villacampa, G., Pascual, T., Brasó-Maristany, F., Paré, L., Martínez-Sáez, O., Cortés, J., Ciruelos, E., Martin, M., Conte, P., Carey, L.A., Fernandez, A., Harbeck, N., Marín-Aguilera, M., Vivancos, A., Curigliano, G., Villagrasa, P., Parker, J.S., Perou, C.M., Prat, A., and Tolaney, S.M.

Published
2024
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6. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up

Author

Loibl, S., André, F., Bachelot, T., Barrios, C.H., Bergh, J., Burstein, H.J., Cardoso, M.J., Carey, L.A., Dawood, S., Del Mastro, L., Denkert, C., Fallenberg, E.M., Francis, P.A., Gamal-Eldin, H., Gelmon, K., Geyer, C.E., Gnant, M., Guarneri, V., Gupta, S., Kim, S.B., Krug, D., Martin, M., Meattini, I., Morrow, M., Janni, W., Paluch-Shimon, S., Partridge, A., Poortmans, P., Pusztai, L., Regan, M.M., Sparano, J., Spanic, T., Swain, S., Tjulandin, S., Toi, M., Trapani, D., Tutt, A., Xu, B., Curigliano, G., and Harbeck, N.

Published
2024
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7. Understanding breast cancer complexity to improve patient outcomes: The St Gallen International Consensus Conference for the Primary Therapy of Individuals with Early Breast Cancer 2023

Author

Aebi, S., Al-Foheidi, M., André, F., Anikusko, M., Badwe, R., Barrio, A.V., Barrios, C., Bergh, J., Bonnefoi, H., Bretel Morales, D., Brucker, S., Burstein, H.J., Caldas, C., Cameron, D., Cardoso, F., Cardoso, M.J., Carey, L., Chia, S., Coles, C., Cortes, J., Curigliano, G., de Boniface, J., Delaloge, S., DeMichele, A., Denkert, C., Fastner, G., Fitzal, F., Francis, P., Gamal, H., Gentilini, O., Gnant, M., Gradishar, W., Gulluoglu, B., Harbeck, N., Heil, J., Huang, C.-S.H., Huober, J., Jiang, Z., Kaidar-Person, O., Kok, M., Lee, E.-S., Loi, S., Loibl, S., Martin, M., Meattini, I., Morrow, M., Partridge, A., Penault-Llorca, F., Piccart, M., Pierce, L., Poortmans, P., Regan, M., Reis-Filho, J., Rubio, I., Rugo, H., Rutgers, E., Saura, C., Senkus, E., Shao, Z., Singer, C., Spanic, T., Thuerlimann, B., Toi, M., Tolaney, S., Turner, N., Tutt, A., Vrancken Peeters, M.-J., Watanabe, T., Weber, W., Wildiers, H., Xu, B., Regan, M.M., Weber, W.P., and Thürlimann, B.

Published
2023
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8. Significantly longer time to deterioration of quality of life due to CANKADO PRO-React eHealth support in HR+ HER2− metastatic breast cancer patients receiving palbociclib and endocrine therapy: primary outcome analysis of the multicenter randomized AGO-B WSG PreCycle trial

Author

Kieback, Dirk Günter, van Mackelenbergh, Marion Tina, Hielscher, Carsten, Ugur, Mustafa Celalettin, Uleer, Christoph, Zahn, Mark-Oliver, Meyer, Ralf, Kraudelt, Susanne, Stefek, Andrea, Pink, Daniel, Just, Marianne, Kolberg, Hans-Christian, Fehm, Tanja, Malter, Wolfram, Warm, Mathias, Forstbauer, Helmut, Behringer, Dirk, Wortmann, Anke, Rom, Joachim, Lehnert, Antje, Ackermann, Sven, Guth, Dagmar, Simon, Eike, Dünnebacke, Jan, Hönig, Arnd, Ehscheidt, Peter, Gnauert, Karsten, Kühn, Thorsten, von Abel, Ekkehard, Hartkopf, Andreas, Karck, Ulrich, Negwer, Martina, Wacker, Jürgen, Welslau, Manfred, Sagasser, Jaqueline, Heinrichm, Bernhard, Brucker, Cosima, Stauder, Heribert, Gröll, Isolde, Felberbaum, Ricardo, Popovic, Milos, Baerens, Dirk-Toralf, Söling, Ulrike, Zaiss, Matthias, Rauh, Jaqueline, Fietz, Thomas, Schröder, Jan, Voß, Hermann, Mohm, Johannes, Neef, Ute, Rieger, Lorenz, Distelrath, Andrea, Nusch, Arnd, Schmidt, Burkhard, Lüdtke-Heckenkamp, Kerstin, Berghorn, Michael, Busch, Steffi, Schock, Caroline, Metz, Michael, Lorenz, Andreas, Uhlig, Jens, Otremba, Burkhard, Harbeck, N., Fasching, P.A., Wuerstlein, R., Degenhardt, T., Lüftner, D., Kates, R.E., Schumacher, J., Räth, P., Hoffmann, O., Lorenz, R., Decker, T., Reinisch, M., Göhler, T., Staib, P., Gluz, O., Schinköthe, T., and Schmidt, M.

Published
2023
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9. Nab-paclitaxel weekly versus dose-dense solvent-based paclitaxel followed by dose-dense epirubicin plus cyclophosphamide in high-risk HR+/HER2− early breast cancer: results from the neoadjuvant part of the WSG-ADAPT-HR+/HER2− trial

Author

Gluz, O., Kuemmel, S., Nitz, U., Braun, M., Lüdtke-Heckenkamp, K., von Schumann, R., Darsow, M., Forstbauer, H., Potenberg, J., Uleer, C., Grischke, E.M., Aktas, B., Schumacher, C., zu Eulenburg, C., Kates, R., Jóźwiak, K., Graeser, M., Wuerstlein, R., Baehner, R., Christgen, M., Kreipe, H.H., and Harbeck, N.

Published
2023
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10. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer

Author

Im, S.-A., Gennari, A., Park, Y.H., Kim, J.H., Jiang, Z.-F., Gupta, S., Fadjari, T.H., Tamura, K., Mastura, M.Y., Abesamis-Tiambeng, M.L.T., Lim, E.H., Lin, C.-H., Sookprasert, A., Parinyanitikul, N., Tseng, L.-M., Lee, S.-C., Caguioa, P., Singh, M., Naito, Y., Hukom, R.A., Smruti, B.K., Wang, S.-S., Kim, S.B., Lee, K.-H., Ahn, H.K., Peters, S., Kim, T.W., Yoshino, T., Pentheroudakis, G., Curigliano, G., and Harbeck, N.

Published
2023
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11. Influence of HER2 expression on prognosis in metastatic triple-negative breast cancer—results from an international, multicenter analysis coordinated by the AGMT Study Group

Author

Balic, Marija, Heibl, Sonja, Zabernigg, August Felix, Egle, Daniel, Sandholzer, Margit, Roitner, Florian, Andel, Johannes, Pichler, Petra, Hager, Christopher, Knauer, Michael, Hubalek, Michael, Bighin, Claudia, De Laurentiis, Michelino, De Placido, Sabino, Puglisi, Fabio, Boni, Luca, de Gregorio, Amelie, Degenhardt, Tom, Formisano, Luigi, Beelen, Karin, Robinson, Timothy, Fitzpatrick, Amanda, Dieras, Veronique, Muller, Volkmar, Gennari, Alessandra, Linn, Sabine, Braga, Sofia, Cortes, Javier, Palmieri, Carlo, Gampenrieder, S.P., Dezentjé, V., Lambertini, M., de Nonneville, A., Marhold, M., Le Du, F., Cortés Salgado, A., Alpuim Costa, D., Vaz Batista, M., Chic Ruché, N., Tinchon, C., Petzer, A., Blondeaux, E., Del Mastro, L., Targato, G., Bertucci, F., Gonçalves, A., Viret, F., Bartsch, R., Mannsbart, C., Deleuze, A., Robert, L., Saavedra Serrano, C., Gion Cortés, M., Sampaio-Alves, M., Vitorino, M., Pecen, L., Singer, C., Harbeck, N., Rinnerthaler, G., and Greil, R.

Published
2023
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12. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up

Author

Rugo, HS, Finn, RS, Diéras, V, Ettl, J, Lipatov, O, Joy, AA, Harbeck, N, Castrellon, A, Iyer, S, Lu, DR, Mori, A, Gauthier, ER, Bartlett, C Huang, Gelmon, KA, and Slamon, DJ

Subjects
Clinical Research, Estrogen, Breast Cancer, Cancer, Clinical Trials and Supportive Activities, Aging, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Humans, Letrozole, Piperazines, Postmenopause, Pyridines, Quality of Life, Receptor, ErbB-2, Receptors, Estrogen, Treatment Outcome, Breast cancer, ER, HER2-, Cyclin-dependent kinase inhibitor, Palbociclib, Receptor, erbB-2, ER+, HER2−, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeIn the initial PALOMA-2 (NCT01740427) analysis with median follow-up of 23 months, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) in women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) [hazard ratio (HR) 0.58; P

Published
2019

14. 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

15. Ten-year results of intense dose-dense chemotherapy show superior survival compared with a conventional schedule in high-risk primary breast cancer: final results of AGO phase III iddEPC trial

Author

Möbus, V, Jackisch, C, Lück, HJ, du Bois, A, Thomssen, C, Kuhn, W, Nitz, U, Schneeweiss, A, Huober, J, Harbeck, N, von Minckwitz, G, Runnebaum, IB, Hinke, A, Konecny, GE, Untch, M, Kurbacher, C, and Group, AGO Breast Study

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Cyclophosphamide, Disease-Free Survival, Dose-Response Relationship, Drug, Epirubicin, Female, Humans, Lymphatic Metastasis, Middle Aged, Paclitaxel, Risk Factors, Survival Rate, high-risk early breast cancer, dose-dense, intense dose-dense, AGO Breast Study Group, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundPrimary breast cancer (BC) patients with extensive axillary lymph-node involvement have a limited prognosis. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) trial compared intense dose-dense (idd) adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk BC patients. Here we report the final, 10-year follow-up analysis.Patients and methodsEnrolment took place between December 1998 and April 2003. A total of 1284 patients with 4 or more involved axillary lymph nodes were randomly assigned to receive 3 courses each of idd sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC → P) q3w. Event-free survival (EFS) was the primary end point.ResultsA total of 658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC → P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43% to 52%) in the standard group and 56% (95% CI 52% to 60%) in the iddEPC group [hazard ratio (HR) 0.74, 95% CI 0.63-0.87; log-rank P = 0.00014, one-sided]. This benefit was independent of menopausal, hormone receptor or HER2 status. Ten-year overall survival (OS) was 59% (95% CI 55% to 63%) for patients in the standard group and 69% (95% CI 65% to 73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P = 0.0007, two-sided). Nine versus two cases of secondary myeloid leukemia/myelodysplastic syndrome were observed in the iddEPC and the EC → P arm, respectively.ConclusionThe previously reported OS benefit of iddEPC in comparison to conventionally dosed EC → P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up.

Published
2018

16. Prognostic relevance of the HER2 status of circulating tumor cells in metastatic breast cancer patients screened for participation in the DETECT study program

Author

Müller, V., Banys-Paluchowski, M., Friedl, T.W.P., Fasching, P.A., Schneeweiss, A., Hartkopf, A., Wallwiener, D., Rack, B., Meier-Stiegen, F., Huober, J., Rübner, M., Hoffmann, O., Müller, L., Janni, W., Wimberger, P., Jäger, B., Pantel, K., Riethdorf, S., Harbeck, N., and Fehm, T.

Published
2021
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17. Early prediction of endocrine responsiveness in ER+/HER2-negative metastatic breast cancer (MBC): pilot study with 18F-fluoroestradiol (18F-FES) CT/PET

Author

Gennari, A., primary, Brain, E., additional, De Censi, A., additional, Nanni, O., additional, Wuerstlein, R., additional, Frassoldati, A., additional, Cortes, J., additional, Rossi, V., additional, Palleschi, M., additional, Alberini, J.L., additional, Matteucci, F., additional, Piccardo, A., additional, Sacchetti, G., additional, Ilhan, H., additional, D’Avanzo, F., additional, Ruffilli, B., additional, Nardin, S., additional, Monti, M., additional, Puntoni, M., additional, Fontana, V., additional, Boni, L., additional, Harbeck, N., additional, Malagutti, Bianca, additional, Dib, Bassam, additional, Branni, Carmen, additional, D’Amico, Mauro, additional, Provinciali, Nicoletta, additional, Corradengo, Davide, additional, Fiz, Francesco, additional, Iacozzi, Massimiliano, additional, and Rocca, Andrea, additional

Published
2024
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18. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Zhang, Q., Xu, B., Shao, Z., Wang, X., Geng, C., Yan, X., Tong, Z., Shen, K., Yin, Y., Sun, T., Yang, J., Feng, J., Yan, M., Wang, Y., Liu, Q., Zhang, S., De Laurentiis, M., Santoro, A., Guarneri, V., Colleoni, M., Natoli, C., Cortesi, L., Placido, S., Gianni, L., Ferrau, F., Livi, L., Zambelli, A., Del Mastro, L., Tonini, G., Montemurro, F., Bianchi, G., Pedersini, R., Prete, S., Allegrini, G., Naso, G., Vici, P., Loirat, D., Mailliez, A., Priou, F., Tredan, O., Dalenc, F., Perrin, C., Gligorov, J., Timar David, M., Dohollou, N., Teixeira, L., Brocard, F., Arnaud, A., Delaloge, S., Spano, J.-P., Mansi, L., Andrade, L., Damian, F., Pedrini, J., Aleixo, S., Hegg, R., Junior, R., Reinisch, M., Schmidt, M., Wenzel, C., Grischke, E.-M., Schneeweiss, A., Just, M., Harbeck, N., Schumacher, C., Peters, U., Fischer, D., Forstbauer, H., Liersch, R., Warner, E., Bouganim, N., Doyle, C., Price Hiller, J., Vandenberg, T., Pavic, M., Robinson, A., Roldan Urgoiti, G., Califaretti, N., Alacacioglu, A., Gumus, M., Yalcin, B., Cicin, I., Kose, F., Uygun, K., Kaplan, M., Cubukcu, E., Wardley, A., Harries, M., Miles, D., Doval, D., Gupta, S., Mohapatra, P., Chatterjee, S., Ghadyalpatil, N., Singhal, M., Nag, S., Agarwal, A., Wolf, I., Gal Yam, E., Yerushalmi, R., Peretz, T., Fried, G., Ben Baruch, N., Katz, D., Hamilton, E., Kayali, F., Brufsky, A., Telli, M., Wright, G., Oyola, R., Rakowski, T., Graff, S., Tjulandin, S., Semiglazov, V., Aparicio, A., Ruiz Borrego, M., Merino, L., Guerra Martinez, J., Lopez, E., Yamashita, T., Ohtani, S., Inoue, K., Ito, Y., Niikura, N., Nakayama, T., Sagara, Y., Yanagita, Y., Kamada, Y., Kaneko, K., Kaen, D., Nervo, A., Eniu, A., Schenker, M., Priester, P., Melichar, B., Zimovjanova, M., Sormova, P., Sufliarsky, J., Kakalejcik, M., Belbaraka, R., Errihani, H., Le Than, D., Pham, D., Aravantinos, G., Papadimitriou, C., Koumakis, G., Papandreou, C., Podolski, P., Tabane, K., André, F., Cameron, D., Barrios, C., Patel, S., Patre, M., Morales, L., Patel, S.L., Kaul, M., Barata, T., and O’Shaughnessy, J.

Published
2021
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21. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)

Author

Cardoso, F., Paluch-Shimon, S., Senkus, E., Curigliano, G., Aapro, M.S., André, F., Barrios, C.H., Bergh, J., Bhattacharyya, G.S., Biganzoli, L., Boyle, F., Cardoso, M.-J., Carey, L.A., Cortés, J., El Saghir, N.S., Elzayat, M., Eniu, A., Fallowfield, L., Francis, P.A., Gelmon, K., Gligorov, J., Haidinger, R., Harbeck, N., Hu, X., Kaufman, B., Kaur, R., Kiely, B.E., Kim, S.-B., Lin, N.U., Mertz, S.A., Neciosup, S., Offersen, B.V., Ohno, S., Pagani, O., Prat, A., Penault-Llorca, F., Rugo, H.S., Sledge, G.W., Thomssen, C., Vorobiof, D.A., Wiseman, T., Xu, B., Norton, L., Costa, A., and Winer, E.P.

Published
2020
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23. Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients

Author

Hack, C.C., Häberle, L., Brucker, S.Y., Janni, W., Volz, B., Loehberg, C.R., Hartkopf, A.D., Walter, C.-B., Baake, G., Fridman, A., Malter, W., Wuerstlein, R., Harbeck, N., Hoffmann, O., Kuemmel, S., Martin, B., Thomssen, C., Graf, H., Wolf, C., Lux, M.P., Bayer, C.M., Rauh, C., Almstedt, K., Gass, P., Heindl, F., Brodkorb, T., Willer, L., Lindner, C., Kolberg, H.-C., Krabisch, P., Weigel, M., Steinfeld-Birg, D., Kohls, A., Brucker, C., Schulz, V., Fischer, G., Pelzer, V., Rack, B., Beckmann, M.W., Fehm, T., Rody, A., Maass, N., Hein, A., Fasching, P.A., and Nabieva, N.

Published
2020
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24. BP50 THERAPY SUPPORT WITH A STANDARDIZED NURSING CONSULTATION FOR PATIENTS UNDER ORALTUMOR THERAPY IN GYNECOLOGICAL ONCOLOGY (BREAST CANCER AND OVARIAN CANCER)

Author

Winkler, Sophie, primary, Hirschberg, L., additional, Henze, F., additional, Milani, V., additional, Schinkoethe, T., additional, Haidinger, R., additional, Paradies, K., additional, Mahner, S., additional, Trillsch, F., additional, Harbeck, N., additional, and Wuerstlein, R., additional

Published
2023
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25. First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial

Author

Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, and Beck R

Subjects
metastatic triple-negative breast cancer, circulating tumor cells, nab-paclitaxel, chemotherapy, prognosis., Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Minetta C Liu,1 Wolfgang Janni,2 Vassilis Georgoulias,3 Denise A Yardley,4 Nadia Harbeck,5 Xin Wei,6 Desmond McGovern,7 Robert Beck7 1Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA; 2Department of Obstetrics and Gynecology, University Clinic Ulm, Ulm, Germany; 3Department of Medical Oncology, School of Medicine, University of Crete, Crete, Greece; 4Department of Medical Oncology, Breast Cancer Research Program, Sarah Cannon Research Institute, Nashville, TN, USA; 5Department of Breast Center, Oncological Therapy and Clinical Trials Unit, University of Munich (LMU), Munich, Germany; 6Department of Translational/Clinical Development, Celgene Corporation, Summit, NJ, USA; 7Department of Clinical Research, Celgene Corporation, Summit, NJ, USACorrespondence: Minetta C LiuDepartment of Laboratory Medicine and Pathology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USATel +1 507 293 0526Email Liu.Minetta@mayo.eduPurpose: Circulating tumor cells (CTCs) are prognostic biomarkers in metastatic breast cancer, but their role in predicting treatment outcomes in metastatic triple-negative breast cancer (mTNBC) is less clear. The tnAcity trial demonstrated a significant progression-free survival (PFS) benefit with nab-paclitaxel (nab-P)/carboplatin (C) over nab-P/gemcitabine (G) or G/C in patients with mTNBC. We assessed the correlation between CTC dynamics and clinical benefit in all patients and by treatment arm.Methods: CTC enumeration, performed using CELLSEARCH technology (Menarini Silicon Biosystems, Huntingdon Valley, PA, USA), was a prespecified exploratory endpoint in the tnAcity trial. Patients with TNBC were categorized based on pre- and post-treatment CTC levels: Group 1 (+ + +; elevated CTCs at baseline and postbaseline), Group 2 (+ ± ±; CTCs elevated at baseline and cleared postbaseline [cycle 3 and/or cycle 5]), or Group 3 (−; no CTCs detected at baseline). The baseline cutoff was ≥1 CTC/7.5 mL for the main analysis; cutoffs of ≥2 and ≥5 CTCs were used for supporting analyses.Results: The main analysis included 126 patients (Group 1, n = 24; Group 2, n = 54; and Group 3, n = 48). The median PFS was longer in Group 2 vs Group 1 (8.5 vs 4.7 months; HR, 0.30 [95% CI, 0.17–0.54]). These results were supported by the ≥2- and ≥5-CTC cutoff analyses. The median overall survival rates were 17.8, 16.0, and 9.8 months in Groups 2, 3, and 1, respectively. The overall response rates were 79.6%, 43.8%, and 29.2%, respectively. A numerically higher percentage of patients had CTC clearance during nab-P/C treatment vs nab-P/G or G/C.Conclusion: Efficacy outcomes trended positively with chemotherapy-induced elimination of CTCs, suggesting that CTC clearance may predict the chemosensitivity of mTNBC tumors.Trial registration: EudraCT Number: 2013-000113-20; ClinicalTrials.gov number: NCT01881230.Keywords: metastatic triple-negative breast cancer, circulating tumor cells, nab-paclitaxel, chemotherapy, prognosis

Published
2019

26. Thyronamine regulation of TAAR1 expression in breast cancer cells and investigation of its influence on viability and migration

Author

Tremmel E, Hofmann S, Kuhn C, Heidegger H, Heublein S, Hermelink K, Wuerstlein R, Harbeck N, Mayr D, Mahner S, Ditsch N, Jeschke U, and Vattai A

Subjects
breast cancer, TAAR1, 3-Iodothyronamine, tetrac, MCF7, T47D, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Eileen Tremmel,1 Simone Hofmann,1 Christina Kuhn,1 Helene Heidegger,1 Sabine Heublein,2 Kerstin Hermelink,1 Rachel Wuerstlein,1 Nadia Harbeck,1 Doris Mayr,3 Sven Mahner,1 Nina Ditsch,1 Udo Jeschke,1 Aurelia Vattai1 1Breast Center, Department of Gynecology and Obstetrics and CCC Munich, University of Munich (LMU), 81377 Munich, Germany; 2Department of Gynecology and Obstetrics, University of Heidelberg, 69120 Heidelberg, Germany; 3Department of Pathology, Ludwig-Maximilians University of Munich, 81337 Munich, Germany Objectives: A correlation exists between breast cancer and thyroid disorders, which are common in elderly women. Thyroid hormones are degraded into trace amines, which can bind to the G-protein-coupled receptor trace amine-associated receptor 1 (TAAR1) and thereby activate it. The transformation of thyroid hormones into trace amines is carried out by the ornithine decarboxylase. Previously, we showed that TAAR1 overexpression (IRS ≥6) was associated with a significantly longer OS in primary breast cancer patients during a long-term follow-up of up to 14 years. Aim of the present study was to analyze the regulation of TAAR1 in breast cancer cell lines and the influence of triiodothyronine (T3), thyronamines, and tetraiodothyroacetic acid (Tetrac) on the expression of TAAR1 in breast cancer cells. Methods: The effect of T3, thyronamines, and Tetrac on the expression of TAAR1 in breast cancer cell lines MCF-7 and T47D was analyzed via PCR and Western blot. A MTT assay was performed to test the metabolic cell viability. A scratch assay was performed to analyze cell migration. Results: Stimulation of MCF-7 cells with 10 nM 3-iodothyronamine (T1AM) significantly increased TAAR1 protein expression (P=0.008). In T47D cells, TAAR1 expression was significantly upregulated after the addition of 10 µg/mL estradiol to 10 nM T1AM (P=0.008). A significant (P=0.028) reduction in MCF-7 cell viability through the incubation with T1AM could be detected. Cell migration of MCF cells was significantly reduced through incubation with 10 nM T1AM. Conclusion: A significant upregulation of TAAR1 induced by stimulation with T1AM may be a sign for an increased decarboxylation of thyroid hormones in breast cancer cells. In addition, there seems to be an influence of estradiol for the T1AM-induced upregulation of TAAR1 in T47D cells. TAAR1-related cell transduction mechanisms seem to be an interesting target for endocrine treatment options of breast cancer patients. Keywords: breast cancer, TAAR1, 3-iodothyronamine, Tetrac, MCF7, T47D

Published
2019

27. Influence of side-effects on early therapy persistence with letrozole in post-menopausal patients with early breast cancer: Results of the prospective EvAluate-TM study

Author

Nabieva, N., Fehm, T., Häberle, L., de Waal, J., Rezai, M., Baier, B., Baake, G., Kolberg, H.-C., Guggenberger, M., Warm, M., Harbeck, N., Wuerstlein, R., Deuker, J.-U., Dall, P., Richter, B., Wachsmann, G., Brucker, C., Siebers, J.W., Popovic, M., Kuhn, T., Wolf, C., Vollert, H.-W., Breitbach, G.-P., Janni, W., Landthaler, R., Kohls, A., Rezek, D., Noesselt, T., Fischer, G., Henschen, S., Praetz, T., Heyl, V., Kühn, T., Krauss, T., Thomssen, C., Hohn, A., Tesch, H., Mundhenke, C., Hein, A., Hack, C.C., Schmidt, K., Belleville, E., Brucker, S.Y., Kümmel, S., Beckmann, M.W., Wallwiener, D., Hadji, P., and Fasching, P.A.

Published
2018
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29. Influence of patient and tumor characteristics on early therapy persistence with letrozole in postmenopausal women with early breast cancer: results of the prospective Evaluate-TM study with 3941 patients

Author

Nabieva, N., Kellner, S., Fehm, T., Häberle, L., de Waal, J., Rezai, M., Baier, B., Baake, G., Kolberg, H.-C., Guggenberger, M., Warm, M., Harbeck, N., Wuerstlein, R., Deuker, J.-U., Dall, P., Richter, B., Wachsmann, G., Brucker, C., Siebers, J.W., Fersis, N., Kuhn, T., Wolf, C., Vollert, H.-W., Breitbach, G.-P., Janni, W., Landthaler, R., Kohls, A., Rezek, D., Noesselt, T., Fischer, G., Henschen, S., Praetz, T., Heyl, V., Kühn, T., Krauss, T., Thomssen, C., Hohn, A., Tesch, H., Mundhenke, C., Hein, A., Rauh, C., Bayer, C.M., Jacob, A., Schmidt, K., Belleville, E., Brucker, S.Y., Kümmel, S., Beckmann, M.W., Wallwiener, D., Hadji, P., and Fasching, P.A.

Published
2018
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31. Time trends (2006–2015) of quality indicators in EUSOMA-certified breast centres

Author

Badbanchi, F., Catalano, G., Cretella, E., Daniaux, M., Emons, A., van Eygen, K., Ettl, J., Gatzemeier, W., Kern, P., Schneeweiss, A., Stoeblen, F., Van As, A., Wuerstlein, R., Zanini, V., van Dam, P.A., Tomatis, M., Marotti, L., Heil, J., Mansel, R.E., Rosselli del Turco, M., van Dam, P.J., Casella, D., Bassani, L.G., Danei, M., Denk, A., Egle, D., Emons, G., Friedrichs, K., Harbeck, N., Kiechle, M., Kimmig, R., Koehler, U., Kuemmel, S., Maass, N., Mayr, C., Prové, A., Rageth, C., Regolo, L., Lorenz-Salehi, F., Sarlos, D., Singer, C., Sohn, C., Staelens, G., Tinterri, C., Audisio, R., and Ponti, A.

Published
2017
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32. De-escalation strategies in HER2-positive early breast cancer (EBC): final analysis of the WSG-ADAPT HER2+/HR− phase II trial: efficacy, safety, and predictive markers for 12 weeks of neoadjuvant dual blockade with trastuzumab and pertuzumab ± weekly paclitaxel

Author

Nitz, U.A., Gluz, O., Christgen, M., Grischke, E. -M., Augustin, D., Kuemmel, S., Braun, M., Potenberg, J., Kohls, A., Krauss, K., Stefek, A., Schumacher, C., Forstbauer, H., Reimer, T., Fischer, H., Liedtke, C., Wuerstlein, R., Schumacher, J., Kates, R., Kreipe, H., and Harbeck, N.

Published
2017
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33. Risk reduction and screening of cancer in hereditary breast-ovarian cancer syndromes: ESMO Clinical Practice Guideline

Author

Sessa, C., Balmaña, J., Bober, S. L., Cardoso, Maria-Joao, Colombo, N., Curigliano, G., Domchek, S. M., Evans, D. G., Fischerova, D., Harbeck, N., Kuhl, C., Lemley, B., Levy-Lahad, E., Lambertini, M., Ledermann, J. A., Loibl, S., Phillips, K.-A., Paluch-Shimon, S., Repositório da Universidade de Lisboa, Sessa, C, Balmana, J, Bober, S, Cardoso, M, Colombo, N, Curigliano, G, Domchek, S, Evans, D, Fischerova, D, Harbeck, N, Kuhl, C, Lemley, B, Levy-Lahad, E, Lambertini, M, Ledermann, J, Loibl, S, Phillips, K, and Paluch-Shimon, S

Subjects
hereditary breast and ovarian cancer syndrome, Oncology, ESMO Clinical Practice Guideline, Hereditary breast and ovarian cancer syndromes, BRCA, Risk reduction, Hematology
Abstract

© 2022 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved

Published
2023

35. 192MO DESTINY-Breast04 subgroup analyses of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with human epidermal growth factor 2 (HER2)-low, estrogen-receptor (ER) expression immunohistochemistry (IHC) 0-10% metastatic breast cancer (mBC)

Author

Cameron, D.A.A., primary, Jacot, W., additional, Yamashita, T., additional, Losada, M.J. Vidal, additional, Schmid, P., additional, Lee, K.S., additional, De Laurentiis, M., additional, Zagouri, F., additional, Ueno, N.T., additional, Prat, A., additional, Harbeck, N., additional, Yerushalmi, R., additional, Lu, Y-S., additional, Gombos, A., additional, Orbegoso, C.M.A., additional, Cheng, F-C., additional, Yung, L., additional, Rajagopalan, R., additional, Tsurutani, J., additional, and Modi, S., additional

Published
2023
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36. 93MO Long-term patient-reported outcomes from monarchE: Abemaciclib plus endocrine therapy for adjuvant HR+, HER2-, node-positive, high-risk, early breast cancer (EBC)

Author

Harbeck, N., primary, Guarneri, V., additional, Seo, J.H., additional, Jurado, J. Cruz, additional, Abreu, M.H., additional, Takahashi, M., additional, Barrios, C.H., additional, McIntyre, K., additional, Wei, R.J., additional, San Antonio, B., additional, Liepa, A.M., additional, Jimenez, M. Martin, additional, Johnston, S.R.D., additional, and Tolaney, S.M., additional

Published
2023
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37. LBA1 Final analysis of the placebo-controlled randomised phase III IMpassion031 trial evaluating neoadjuvant atezolizumab (atezo) plus chemotherapy (CT) followed by open-label adjuvant atezo in patients (pts) with early-stage triple-negative breast cancer (eTNBC)

Author

Barrios, C., primary, Harbeck, N., additional, Zhang, H.A., additional, Saji, S., additional, Jung, K.H., additional, Hegg, R., additional, Koehler, A., additional, Sohn, J., additional, Iwata, H., additional, Telli, M.L., additional, Boileau, J-F., additional, Punie, K., additional, Dieterich, M., additional, Assaf, Z.J.F., additional, Xu, T., additional, Liste Hermoso, M., additional, Shearer-Kang, E., additional, Molinero, L., additional, Chui, S.Y., additional, and Mittendorf, E.A., additional

Published
2023
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38. Significantly longer time to deterioration of quality of life due to CANKADO PRO-React eHealth support in HR+ HER2- metastatic breast cancer patients receiving palbociclib and endocrine therapy: Primary outcome analysis of the multicenter randomized AGO-B WSG PreCycle trial

Author

Harbeck, N., primary, Fasching, P.A., additional, Würstlein, R., additional, Degenhardt, T., additional, Lüftner, D., additional, Kates, R.E., additional, Schumacher, J., additional, Räth, P., additional, Hoffmann, O., additional, Lorenz, R., additional, Decker, T., additional, Reinisch, M., additional, Göhler, T., additional, Staib, P., additional, Gluz, O., additional, Schinköthe, T., additional, and Schmidt, M., additional

Published
2023
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39. 190MO Association of 18-Gene expression profile (GEP) with clinical outcomes in patients with metastatic triple-negative breast cancer (mTNBC) treated with pembrolizumab (Pembro) or chemotherapy (Chemo) in KEYNOTE-119

Author

Cortés, J., primary, Lipatov, O., additional, Im, S-A., additional, Gonçalves, A., additional, Lee, K.S., additional, Schmid, P., additional, Tamura, K., additional, Testa, L., additional, Ohtani, S., additional, Harbeck, N., additional, Loi, S., additional, Salgado, R.F., additional, Lunceford, J., additional, Karantza, V., additional, Mejia, J.A., additional, Cristescu, R., additional, Nebozhyn, M., additional, Jelinic, P., additional, Huang, L., additional, and Winer, E.P., additional

Published
2023
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40. 195P Impact of an interactive eHealth system for patient reported outcomes on safety in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated by palbociclib and endocrine therapy

Author

Harbeck, N., primary, Kates, R.E., additional, Schinköthe, T., additional, Schumacher, J., additional, Degenhardt, T., additional, Würstlein, R., additional, Lüftner, D.I., additional, Hoffmann, O., additional, Raeth, P., additional, Lorenz, R., additional, Decker, T., additional, Reinisch, M., additional, Göhler, T., additional, Staib, P., additional, Gluz, O., additional, Fasching, P.A., additional, and Schmidt, M., additional

Published
2023
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41. 18P A translational project of the WSG-ADAPT-TN trial demonstrates immunomodulatory and anti-viral defense gene networks predicting pathological complete response (pCR) and survival after de-escalated neoadjuvant chemotherapy (NACT) in early triple-negative breast cancer (eTNBC)

Author

Graeser, M., primary, Harbeck, N., additional, Gluz, O., additional, Nitz, U.A., additional, Christgen, M., additional, Kuemmel, S., additional, Grischke, E-M., additional, Forstbauer, H., additional, Braun, M., additional, Warm, M., additional, Hackmann, J.C., additional, Uleer, C., additional, Aktas, B., additional, Würstlein, R., additional, Pelz, E., additional, Eulenburg, C. Zu, additional, Kreipe, H., additional, Trau, M., additional, Stirzaker, C., additional, and Korbie, D., additional

Published
2023
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43. 102P HER2DX risk-score in early-stage HER2-positive (HER2+) breast cancer: A correlative analysis of 757 patients from the Sweden Cancerome Analysis Network - Breast (SCAN-B) dataset

Author

Pascual, T., primary, Villacampa, G., additional, Brasó-Maristany, F., additional, Brunet, L. Pare, additional, Saez, O. Martinez, additional, Cortés, J., additional, Ciruelos, E.M., additional, Jimenez, M. Martin, additional, Conte, P.F., additional, Carey, L.A., additional, Fernandez-Martinez, A., additional, Harbeck, N., additional, Marín-Aguilera, M., additional, Vivancos, A., additional, Curigliano, G., additional, Gonzalez, P. Villagrasa, additional, Parker, J., additional, Tolaney, S.M., additional, Perou, C.M., additional, and Prat, A., additional

Published
2023
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46. P018 TROPION-Breast03: Datopotamab deruxtecan (Dato-DXd) ± durvalumab vs investigator’s choice of therapy (ICT) for triple-negative breast cancer (TNBC) with residual disease following neoadjuvant therapy

Author

Bardia, A., primary, Pusztai, L., additional, Albain, K., additional, Kalinsky, K., additional, Hershman, D., additional, Barlow, W., additional, Tokunaga, E., additional, Ciruelos, E.M., additional, Loirat, D., additional, Isaacs, C., additional, Testa, L., additional, Dry, H., additional, Kozarski, R., additional, Maxwell, M., additional, Harbeck, N., additional, and Sharma, P., additional

Published
2023
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47. P125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study

Author

Kümmel, S., primary, Schmid, P., additional, Harbeck, N., additional, Takahashi, M., additional, Untch, M., additional, Boileau, J.-F., additional, Cortes, J., additional, McArthur, H., additional, Dent, R., additional, O’Shaughnessy, J., additional, Pusztai, L., additional, Foukakis, T., additional, Park, Y.H., additional, Hui, R., additional, Cardoso, F., additional, Denkert, C., additional, Zhu, Y., additional, Pan, W., additional, Karantza, V., additional, and Fasching, P., additional

Published
2023
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49. P017 Abemaciclib + endocrine therapy (ET) for HR+, HER2-, node-positive, high-risk EBC: results from a pre-planned monarchE overall survival (OS) interim analysis (IA), including 4-year efficacy outcomes

Author

Johnston, S., primary, Toi, M., additional, O’Shaughnessy, J., additional, Rastogi, P., additional, Campone, M., additional, Neven, P., additional, Huang, C.S., additional, Huober, J., additional, Jaliffe, G. Garnica, additional, Cicin, I., additional, Tolaney, S., additional, Goetz, M.P., additional, Rugo, H., additional, Senkus, E., additional, Testa, L., additional, Del Mastro, L., additional, Shimizu, C., additional, Wei, R., additional, Shahir, A., additional, Munoz, M., additional, Antonio, B. San, additional, Andre, V., additional, Harbeck, N., additional, and Martín, M., additional

Published
2023
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50. P111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11)

Author

Harbeck, N., primary, Boileau, J.-F., additional, Modi, S., additional, Kelly, C., additional, Ohno, S., additional, Wu, J., additional, Konpa, A., additional, Herbolsheimer, P., additional, Safdar, S., additional, Zhang, Y., additional, and Pusztai, L., additional

Published
2023
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