postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Inclusion Criteria:
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
Have radiologic evidence of disease progression or recurrence either
Must be deemed appropriate for treatment with ET
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
Exclusion Criteria:
Fort Myers, Florida 33901-8101, United States
Miami, Florida 33136, United States
Sarasota, Florida 34232, United States
West Palm Beach, Florida 33401, United States
Baton Rouge, Louisiana 70809, United States
Chattanooga, Tennessee 37404, United States
Nashville, Tennessee 37203, United States
CABA, Buenos Aires F.D. 1125, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Air C1027AAP, Argentina
Bordeaux, Aquitaine 33076, France
Ramat Gan, Central District 5265601, Israel
Meldola, Emilia-Romagna 47014, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Mexicali, Estado de Baja California 21200, Mexico
Opole, Opole Voivodeship 45-060, Poland
Istanbul, 34722, Turkey (Türkiye)