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Nadia Harbeck, MD, PhD

Articles by Nadia Harbeck, MD, PhD

30 Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and Combined With Abemaciclib, for Patients with ER+, HER2– Advanced Breast Cancer, Pretreated With Endocrine Therapy: Results of the Phase 3 EMBER-3 Trial

ByAarti Chawla,Komal Jhaveri,Patrick Neven, MD, PhD,Monica Lis Casalnuovo,Sung-Bae Kim,Eriko Tokunaga,Philippe Aftimos,Cristina Saura,Joyce A. O’Shaughnessy,Nadia Harbeck, MD, PhD,Lisa A. Carey, MD,Guiseppe Curigliano,Antonio Llombart-Cussac,Elgene Lim, MBBS, FRACP, PhD,María de la Luz García Tinoco,Joohyuk Sohn,Andre Mattar,Qingyuan Zhang,Chiun-Sheng Huang,Chih-Chiang Hung,Jorge Luis Martinez Rodriguez,Manuel Ruiz Borrego

46 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for High-Risk, Early-Stage Triple-Negative Breast Cancer: Overall Survival and Subgroup Results From the Phase 3 KEYNOTE-522 Study

ByHeather McArthur, MD, MPH,Peter A. Fasching,Rebecca Dent, MD,Javier Cortés, MD,Lajos Pusztai, MD, DPhil,Sherko Kuemmel,Carsten Denkert,Yeon Hee Park,Rina Hui,Nadia Harbeck, MD, PhD,Masato Takahashi,Seock-Ah Im,Michael Untch, MD, PhD,Marie-Ange Mouret-Reynier,Theodoros Foukakis,Marta Ferreira,Fatima Cardoso,Yu Ding,Cecilia Pinheiro,Jaime Mejia,Joyce A. O’Shaughnessy,Peter Schmid, MD

106 Extended Adjuvant Neratinib in HER2+/HR+ Early Breast Cancer in Clinical Routine: Interim Analysis of the Multinational, Prospective, Noninterventional Study ELEANOR (N=300)

ByReshma L. Mahtani, DO ,Diana Lüftner,Denise Wrobel,Dagmar Guth,Matthias Zaiss,Jürgen Terhaag,Mark-Oliver Zahn,Lidia Pervola-Griff,Andrea Distelrath,Rachel Würstlein,Jörg Thomalla,Klaus Apel,Natalija Deuerling,Timo Schinköthe,Corinne Vannier,Rupert Bartsch,Christian Jackisch,Volkmar Müller,Marcus Schmidt,Marija Balic,Gabriel Rinnerthaler,Urs Breitenstein,Khalil Zaman,Michael Schwitter,Nadia Harbeck, MD, PhD
11 Phase 3 Study of Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy, Followed by Adjuvant Pembrolizumab or Placebo Plus Endocrine Therapy for Early-Stage High-Risk ER+/HER2– Breast Cancer: KEYNOTE-756

11 Phase 3 Study of Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy, Followed by Adjuvant Pembrolizumab or Placebo Plus Endocrine Therapy for Early-Stage High-Risk ER+/HER2– Breast Cancer: KEYNOTE-756

ByFatima Cardoso,Joyce O’Shaughnessy, MD,Heather McArthur, MD, MPH,Peter Schmid, MD,Javier Cortés, MD,Nadia Harbeck, MD, PhD,Melinda L. Telli, MD,David W. Cescon,Peter A. Fasching,Zhimin Shao,Delphine Loirat,Yeon Hee Park,Manuel Gonzalez Fernandez,Gábor Rubovszky,Seock-Ah Im,Rina Hui,Toshimi Takano,Fabrice André,Hiroyuki Yasojima,Zhenzhen Liu,Yu Ding,Liyi Jia,Vassiliki Karantza,Konstantinos Tryfonidis,Aditya Bardia, MD, MPH
31 Adjuvant Abemaciclib Plus Endocrine Therapy for HR+, HER2–, High-Risk Early Breast Cancer: Results From a Preplanned MonarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes

31 Adjuvant Abemaciclib Plus Endocrine Therapy for HR+, HER2–, High-Risk Early Breast Cancer: Results From a Preplanned MonarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes

ByHope S. Rugo, MD,Nadia Harbeck, MD, PhD,Priya Rastogi, MD,Joyce O’Shaughnessy, MD,Frances Boyle,Javier Cortés, MD,Matthew P. Goetz, MD,Erika P. Hamilton, MD,Chiun-Sheng Huang,Elżbieta Senkus,Alexey Tryakin,Patrick Neven, MD, PhD,Jens Huober, MD,Ran Wei,Valérie André,Maria Munoz,Belen San Antonio,Ashwin Shahir,Miguel Martin, MD, PhD,Stephen Johnston
32 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for Early-Stage Triple- Negative Breast Cancer: Updated Event-Free Survival Results From the Phase 3 KEYNOTE-522 Study

32 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for Early-Stage Triple- Negative Breast Cancer: Updated Event-Free Survival Results From the Phase 3 KEYNOTE-522 Study

ByPeter Schmid, MD,Javier Cortes,Rebecca Dent, MD,Lajos Pusztai, MD, DPhil,Heather McArthur, MD, MPH,Sherko Kümmel,Carsten Denkert,Yeon Hee Park,Rina Hui,Nadia Harbeck, MD, PhD,Masato Takahashi,Theodoros Foukakis,Marie-Ange Mouret-Reynier,Marta Ferreira,Seock-Ah Im,Fatima Cardoso,Yu Ding,Wilbur Pan,Konstantinos Tryfonidis,Joyce O’Shaughnessy, MD

Anthracycline and Trastuzumab in Breast Cancer Treatment

ByMichael Untch, MD, PhD,I. Himsl, MD,Steffen Kahlert, MD,H. J. Lueck, MD,H. Eidtmann, MD,Andreas Du Bois, MD, PhD,H. G. Meerpohl, MD,Christoph Thomssen, MD, PhD,Nadia Harbeck, MD, PhD,C. Jackisch, MD,R. Kreienberg, MD,G. Emons, MD,Diethelm Wallwiener, MD,W. Wiese, MD,G. Schaller, MD,W. Kuhn, MD,M. Muscholl, MD,M. Pauschinger, MD,B. Langer, MD

This study was designed to evaluate the cardiac safety of the combined treatment of HER2-positive metastaticbreast cancer patients with trastuzumab (Herceptin) plus epirubicin and cyclophosphamide (EC) incomparison with EC alone in HER2-negative metastatic breast cancer patients. Patients included those withmetastatic breast cancer without any prior anti-HER2 treatment, anthracycline therapy, or any other chemotherapyfor metastatic disease. This was a nonrandomized, prospective, dose-escalating, multicenter, openlabel,phase II study in Germany. A control group of 23 patients received EC 90/600 mg/m2 3-weekly for sixcycles (EC90 alone). A total of 26 HER2-positive patients were treated with trastuzumab, or H (2 mg/kg weeklyafter an initial loading dose of 4 mg/kg), and EC 60/600 mg/m2 3-weekly for six cycles (EC60+H); another 25HER2-positive patients received H and EC 90/600 mg/m2 3-weekly for six cycles. Asymptomatic reductions inleft ventricular ejection fraction (LVEF) of more than 10% points were detected in 12 patients (48%) treatedwith EC60 + H and in 14 patients (56%) treated with EC90 + H vs 6 patients (26%) in the EC90 alone cohort.LVEF decreases to < 50% occurred in one patient in the EC60+H cohort and in two patients in the EC90+Hcohort during the H monotherapy. No cardiac event occurred in the cohort with EC90 alone. The overallresponse rates for EC60+H and EC90+H were >60%, vs 26% for EC90 alone. The interim results of this studysuggest the cardiac safety of the combination of H with EC may be greater than that of H with AC (doxorubicin[Adriamycin]/cyclophosphamide); however, studies in larger numbers of patients are warranted. The combinationregimen revealed promising efficacy.

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