Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasm, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT05169567

Run by

Eli Lilly and Company

People needed

368

Starts

2022-03-11

Expected to finish

2027-12-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
• Have radiologic evidence of disease progression or recurrence either
• On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
• On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
• 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

You may not qualify if…

• Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
• Have symptomatic or untreated central nervous system metastasis
• Have received any systemic therapy between disease recurrence/progression and study screening
• Have received more than 1 line of therapy for advanced or metastatic disease.
• Have received prior chemotherapy for metastatic breast cancer (MBC)
• Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• Providence Medical Foundation — Fullerton, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• TRIO-US (Translational Research in Oncology-US) — Los Angeles, California, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• UCLA Hematology/Oncology - Parkside — Santa Monica, California, United States
• Olive View-UCLA Medical Center — Sylmar, California, United States
• Torrance Memorial Physician Network / Cancer Care — Torrance, California, United States
• PIH Health Hematology Medical Oncology — Whittier, California, United States
• Rocky Mountain Cancer Center - Hale Parkway — Denver, Colorado, United States
• Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI — Fort Myers, Florida, United States
• Millennium Oncology Research Clinic — Hollywood, Florida, United States
• University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami, Florida, United States
• Woodlands Medical Specialists, PA — Pensacola, Florida, United States
• Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI — Sarasota, Florida, United States
• Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI — West Palm Beach, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Central Georgia Cancer Care — Macon, Georgia, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI — Baton Rouge, Louisiana, United States
• Clinical Trials of SWLA — Lake Charles, Louisiana, United States
• Central Maine Medical Center — Lewiston, Maine, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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