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Breast cancer, metastatic

3996 - Everolimus (EVE) + letrozole (LET) in patients (pts) with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC): progression-free survival (PFS) subgroup analyses in BOLERO-4


10 Sep 2017


Breast cancer, metastatic


Cytotoxic Therapy;  Breast Cancer


Thomas Bachelot


Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365


T. Bachelot1, M. Royce2, C. Villanueva3, F. Melo Cruz4, R. Hegg5, C. Falkson6, J. Jeong7, V. Srimuninnimit8, C.H. Arce9, A. Ridolfi10, C. Lin9, W. Gradishar11, M. Ozguroglu12, F. Cardoso13, S. Azevedo14

Author affiliations

  • 1 Breast Cancer Unit And The Clinical Trial Unit, Centre Léon Bérard, 69008 - Lyon/FR
  • 2 Department Of Internal Medicine, University of New Mexico Comprehensive Cancer Center, 87131 - Albuquerque/US
  • 3 Service D'oncologie Médicale, CHU Besançon, 25030 - Besançon/FR
  • 4 Oncology, Instituto Brasileiro de Controle do Cancer, 3474-4222 - Mooca/BR
  • 5 Centro De Referência Da Saúde Da Mulher, Hospital Pérola Byington/Faculdade de Medicina da Universidade de São Paulo, 01317 - Sao Paulo/BR
  • 6 Hematology/oncology, University of Alabama Comprehensive Cancer Center, 35294-3280 - Birmingham/US
  • 7 Department Of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 135-720 - Seoul/KR
  • 8 Division Of Oncology, Siriraj Hospital, Mahidol University, 10700 - Bangkok/TH
  • 9 Global Medical Affairs, Oncology, Novartis Pharmaceuticals Corporation, 07936 - East Hanover/US
  • 10 Oncology, Novartis Pharma S.A.S., 92500 - Rueil-Malmaison/FR
  • 11 Hematology/oncology, Northwestern University Feinberg School of Medicine, 60611 - Chicago/US
  • 12 Department Of Internal Medicine, Istanbul University Hospital, 34098 - Istanbul/TR
  • 13 Breast Unit, Champalimaud Foundation Cancer Center, 1400-038 - Lisboa/PT
  • 14 Oncology, Hospital de Clínicas de Porto Alegre, 90035903 - Porto Alegre/BR


Abstract 3996


The BOLERO-4 study demonstrated clinical benefit and an acceptable safety profile with first-line (1L) EVE + LET in postmenopausal pts with ER+, HER2− ABC. Pre-specified subgroup analyses evaluated PFS in pt subgroups: age (


BOLERO-4 is an open-label, Phase II, multicenter, international, single-arm trial. Postmenopausal pts with ER+, HER2− ABC, with no prior therapy for advanced disease, received EVE 10 mg/day + LET 2.5 mg/day until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was locally assessed 1L PFS on the overall full analysis set (FAS). Here we report 1L PFS data that was assessed based on the aforementioned pt subgroups. BOLERO-4 is registered with ClinicalTrials.gov (NCT01698918).


At the data cut-off (Dec 17, 2016), 202 pts with ABC were enrolled for 1L treatment with EVE + LET. Median PFS, and 18- and 24-month Kaplan−Meier-estimated PFS rates were similar to the FAS irrespective of pt age, presence/absence of visceral metastases, or presence/absence of bone-only lesions at baseline (Table). The distribution and frequency of all-grade adverse events (regardless of causality) among pts aged


Treatment benefit with EVE + LET in the 1L setting was maintained across pt subgroups and was consistent with that observed in the FAS of the BOLERO-4 study. EVE + LET, therefore, is an effective 1L treatment for ER+, HER2− ABC, irrespective of pt age, visceral metastases, or bone-only lesions. These data support the potentially important role of EVE in the ABC treatment landscape.

Clinical trial identification

Protocol version 04

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation


Novartis Pharmaceuticals Corporation


T. Bachelot: Research funding from Roche, Novartis. Consultant for and travel expenses from AstraZeneca, Roche, Novartis, Pfizer. M. Royce: Research funding and honoraria from Novartis. C. Villanueva: Advisory board member for Novartis Pharmaceuticals Corporation. F. Melo Cruz: Research funding from Novartis, Janssen, Roche, Celgene. Travel, accommodation, expenses from Janssen. C. Falkson: Research funding from Novartis, Oncothyreon, Genentech, EMD Serono. Consultant for and honoraria from Biotheranostics. J. Jeong: Research funding from Dong-A, Boryung, LG Life Sciences, Antigen. Honoraria from Roche, Alvogen, Novartis, Pfizer, Covidien. C.H. Arce: BD and Novartis employee. Stocks with BD. A. Ridolfi: Novartis Pharma S.A.S. employee. C. Lin: Novartis employee and stocks. F. Cardoso: Research funding for clinical trials by institution. Consultant for Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, GSK, MacroGenics, Merck, Merus BV, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Teva. All other authors have declared no conflicts of interest.

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