A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Inclusion Criteria:
Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
The participant must have undergone definitive surgery of the primary breast tumor.
The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:
The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
The participant has adequate organ function.
The participant is able to swallow oral medications.
Exclusion Criteria:
Burbank, California 91505, United States
Sacramento, California 95817, United States
Tampa, Florida 33612, United States
Marietta, Georgia 30060, United States
Cary, North Carolina 27518, United States
The Woodlands, Texas 77380, United States
CABA, Ciudad Autonoma Buenos Aires 1125, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Ciudad Autonoma Buenos Aires, C1430EGF, Argentina
Liège, Liège 4000, Belgium
Yvoir, Namur 5000, Belgium
Sao Jose Rio Preto, São Paulo 15091-000, Brazil
São Paulo, 04038-034, Brazil
Sherbrooke, Quebec J1J 3H5, Canada
Shanghai, Shanghai Municipality 200025, China
Hangzhou, Zhejiang 310052, China
Brest, Brittany Region 29200, France
Rennes, Ille-et-Vilaine 35042, France
Clermont-Ferrand, Puy-de-Dôme 63011, France
Rouen, Seine-Maritime 76038, France
Freiburg im Breisgau, Baden-Wurttemberg 69126, Germany
Friedrichshafen, Baden-Wurttemberg 88045, Germany
Krefeld, North Rhine-Westphalia 47805, Germany
Mönchengladbach, North Rhine-Westphalia 41061, Germany
Münster, North Rhine-Westphalia 52074, Germany
Berlin, 14195, Germany
Hksar, Hong Kong
Hyderabad, Andhra Pradesh 500004, India
Ramat Gan, Central District 5265601, Israel
Meldola, Emilia-Romagna 47014, Italy
Osaka Sayama-shi, Osaka 589 8511, Japan
Ina-machi, Saitama 362-0806, Japan
Bunkyō-Ku, Tokyo 113-8431, Japan
Chuo Ku, Tokyo 104-0045, Japan
Chuo-Ku, Tokyo 104 8560, Japan
Koto, Tokyo 135-8550, Japan
Shinagawa-ku, Tokyo 142-8555, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjuku-ku, Tokyo 162-8655, Japan
Warsaw, Masovian Voivodeship 02-781, Poland
Opole, Opole Voivodeship 45-061, Poland
Lodz, Łódź Voivodeship 90338, Poland
Saint Petersburg, Sankt-Peterburg 191015, Russia
Saint Petersburg, Sankt-Peterburg 197022, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Cheonan-si, Chungcheongnam-do [Chungnam] 31151, South Korea
Namdong-gu, Incheon-gwangyeoksi [Incheon] 21565, South Korea
Haeundae-gu, Pusan-Kwangyǒkshi 48108, South Korea
Seoul, Seoul-teukbyeolsi [Seoul] 3722, South Korea
Salamanca, 37007, Spain
Kaohsiung Niao Sung Dist, Kaohsiung 83301, Taiwan
Taipei City, Taipei 114, Taiwan
Istanbul- Fatih, Istanbul 34098, Turkey (Türkiye)
Üsküdar/stanbul, Istanbul 34662, Turkey (Türkiye)
Izmir, Karsiyaka, İzmir 9035575, Turkey (Türkiye)
Ankara, Turkey 6200, Turkey (Türkiye)
Istanbul, 34090, Turkey (Türkiye)
Dnipro, Dnipropetrovsk Oblast 49102, Ukraine
Kryvyi Rih, Dnipropetrovsk Oblast 50048, Ukraine
Odesa, Odesa Oblast 65025, Ukraine
Vinnytsia, Vinnytsia Oblast 21029, Ukraine
Lutsk, Volyn Oblast 43018, Ukraine
Central Middlesbrough, Middlesbrough TS4 3BW, United Kingdom