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Poster display session

4834 - EarLEE-1: A phase 3 study of ribociclib + endocrine therapy (ET) for adjuvant treatment of patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–), high-risk, early breast cancer (EBC)


11 Sep 2017


Poster display session


Miguel Martin Jimenez


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


M. Martin Jimenez1, T. Bachelot2, C. Barrios3, K. Blackwell4, S. Chia5, M. De Laurentiis6, S. Hurvitz7, W. Janni8, B. Kaufman9, S. Loi10, P. Schmid11, D. Slamon12, K. Hazell13, S. Mondal13, M. Shilkrut13, C. Germa14, G. Hortobagyi15

Author affiliations

  • 1 Medical Oncology Service, Hospital General Universitario Gregorio Marañón, 28007 - Madrid/ES
  • 2 Département D'oncologie Médicale Adulte, Centre Léon Bérard, 69008 - Lyon/FR
  • 3 Medical Oncology, Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre/BR
  • 4 Multidisciplinary Breast Program, Duke University Medical Center, 27710 - Durham/US
  • 5 Medical Oncology, BC Cancer Agency - Vancouver Cancer Center, Vancouver/CA
  • 6 Oncology, IRCCS Fondazione G. Pascale, Naples/IT
  • 7 Translational Research In Oncology, University of California, Los Angeles/US
  • 8 Department Of Gynecology And Obstetrics, Ulm Medical University, 89081 - Ulm/DE
  • 9 Breast Medical Oncolog, Sheba Medical Center at Tel HaShomer, Ramat Gan/IL
  • 10 Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 11 Breast Center, Barts Cancer Institute, London/GB
  • 12 Breast Oncology Program, UCLA - School of Medicine, 90095 - Los Angeles/US
  • 13 Novartis Pharmaceuticals, Novartis Pharmaceuticals, East Hanover/US
  • 14 Medical Oncology, Novartis Pharmaceuticals, 07936-1080 - East Hanover/US
  • 15 Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US


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Abstract 4834


Adjuvant ET and chemotherapy reduce the risk for recurrence of HR+, HER2– EBC. However, recurrence is still common in pts with adverse clinical and pathologic features. In the phase 3 clinical trial MONALEESA-2, the cyclin-dependent kinase 4/6 inhibitor ribociclib in combination with letrozole prolonged progression-free survival versus letrozole plus placebo in postmenopausal women with HR+, HER2– advanced breast cancer and no prior therapy for advanced disease (HR = 0.56, 95% CI, 0.43-0.72; P = 3.29 × 10−6; Hortobagyi et al. N Engl J Med. 2016). EarLEE-1 (NCT03078751) investigates the efficacy and safety of ribociclib with ET versus placebo with ET as adjuvant treatment in pts with high-risk EBC.

Trial design

In this double-blind, placebo-controlled, phase 3 trial, ∼2000 women and men with fully resected, high-risk, HR+, HER2– EBC (defined as AJCC 8th ed. Prognostic Stage Group III for pts who received adjuvant chemotherapy, or > 2 mm residual disease in axillary lymph nodes and > 10 mm in breast after neoadjuvant chemotherapy) are being randomized 1:1 to ribociclib (600 mg/day, 3 weeks on/1 week off for ∼24 months) with ET or placebo with ET. Adjuvant ET may include tamoxifen, letrozole, anastrozole, or exemestane for ≥ 60 months with ovarian suppression for premenopausal women. Randomization is stratified by menopausal status, risk group, and region. Eligible pts must have tumor tissue from the surgical specimen, adequate bone marrow and organ functions, normal serum electrolytes, QTc interval < 450 msec, and completed and recovered from acute toxicities of adjuvant radiotherapy and (neo)adjuvant chemotherapy. The primary endpoint is invasive disease-free survival. Secondary endpoints include recurrence-free survival, distant disease-free survival, overall survival, quality of life, and safety. Global recruitment is ongoing.

Clinical trial identification


Legal entity responsible for the study

Novartis Pharmaceuticals


Novartis Pharmaceuticals


M. Martin Jimenez: The institution has received research funding from Novartis. T. Bachelot: Grants, personal fees and non-financial support from Roche, grants, personal fees and non-financial support from Novartis, grants and personal fees from AstraZeneca, outside the submitted work. C. Barrios: Grants and/or personal fees: Pfizer, Novartis, Amgen, AstraZeneca, B, GSK, Roche-Genentech, Lilly, Sanofi, Taiho, Mylan, Merrimack, Merck, Abbvie, Astellas, Biomarin, Bristol-Myers Squibb, Daiichi, Abraxis, AB, Asana Bios, Medivation, Exelixis, ImClone, LEO, Millennium, Pfizer, Eisai. K. Blackwell: Grants and/or personal fees: Novartis, Amgen, AstraZeneca, Advaxis, Bayer, Celgene, Coherus, Eisai, Eli Lilly, Genentech, GI Thera, Hospira, MacroGenics, Merck, Pfizer, Pierian Bio, Puma, Roche, Rockwell, Sandoz, Spectrum. M. De Laurentiis: Consulting and/or advisory role and speakers\' bureau from Novartis, Roche, Pfizer, AstraZeneca, Clegene and Eisai. S. Hurvitz: Grants from Amgen, Bayer, BI, Genetech, GSK, Pfizer, Roche, Biomarin, Merrimack, PUMA, Dignitana, Medivation, Lilly, Novartis and OBI Pharma, outside of the submitted work. S. Loi: Grants from Novartis, Merck, Roche-Genentech, Pfizer, during the conduct of the study. P. Schmid: Personal fees from Pfizer, Boehringer Ingelheim, Bayer, Puma, Eisai, Celgene, Roche-Genentech, during the conduct of the study. K. Hazell, S. Mondal, M. Shilkrut, C. Germa: Employee of Novartis Pharmaceuticals Corporation. All authors have declared no conflicts of interest.

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