A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

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

Conditions studied: Breast Neoplasms

In brief

The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

Key facts

Study ID: NCT02107703
Run by: Eli Lilly and Company
People needed: 669
Starts: 2014-07-22
Expected to finish: 2027-12-01
Last updated by the study team: 2025-10-21

Who can join

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

You may qualify if…

Have a diagnosis of HR+, HER2- breast cancer
Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:
relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
Have either measurable disease or nonmeasurable bone only disease
Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy

You may not qualify if…

Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
Have clinical evidence or history of central nervous system metastasis
Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
Have received recent (within 28 days prior to randomization) yellow fever vaccination
Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
Have received an autologous or allogeneic stem-cell transplant
Have active bacterial or fungal infection, or detectable viral infection
Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents <7 days prior to randomization

Where it is running

Highlands Oncology Group — Springdale, Arkansas, United States
University of California - San Diego — La Jolla, California, United States
Kaiser Permanente — Riverside, California, United States
Univ of California San Francisco — San Francisco, California, United States
Stanford University Clinic — Stanford, California, United States
Palm Beach Cancer Institue — Atlantis, Florida, United States
Holy Cross Hospital — Fort Lauderdale, Florida, United States
Florida Cancer Specialists - South — Fort Myers, Florida, United States
Palm Beach Cancer Institue — Palm Beach Gardens, Florida, United States
Florida Cancer Specialists - North — St. Petersburg, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center — Tampa, Florida, United States
Palm Beach Cancer Institue — Wellington, Florida, United States
Palm Beach Cancer Institue — West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC — Athens, Georgia, United States
Harbin Clinic — Rome, Georgia, United States
Quincy Medical Group — Quincy, Illinois, United States
Pharmasite Research, Inc. — Baltimore, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Breslin Cancer Center — Lansing, Michigan, United States
Minnesota Oncology/Hematology PA — Minneapolis, Minnesota, United States
Washington University Medical School — City of Saint Peters, Missouri, United States
Washington University Medical School — Creve Coeur, Missouri, United States
Freeman Cancer Institute — Joplin, Missouri, United States
St Lukes Hospital — Kansas City, Missouri, United States
St. Bernards Medical Center — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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