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Clinical Trials in China / NCT02107703
Active, not recruiting Phase 3

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

NCT02107703 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2014-07-22
Last updated
2025-10-21

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

AbemaciclibFulvestrantPlacebo

Abemaciclib: Administered Orally

Fulvestrant: Administered IM

Placebo: Administered Orally

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * 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 Exclusion Criteria * 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

Primary outcome measure(s)

Trial sites (146)

FacilityCityRegionStatus
St. Bernards Medical Center Jonesboro Arkansas
Highlands Oncology Group Springdale Arkansas
University of California - San Diego La Jolla California
Kaiser Permanente Riverside California
Univ of California San Francisco San Francisco California
Stanford University Clinic Stanford California
Palm Beach Cancer Institue Atlantis Florida
Holy Cross Hospital Fort Lauderdale Florida
Florida Cancer Specialists - South Fort Myers Florida
Palm Beach Cancer Institue Palm Beach Gardens Florida
Florida Cancer Specialists - North St. Petersburg Florida
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center Tampa Florida
Palm Beach Cancer Institue Wellington Florida
Palm Beach Cancer Institue West Palm Beach Florida
University Cancer & Blood Center, LLC Athens Georgia
Harbin Clinic Rome Georgia
Quincy Medical Group Quincy Illinois
Pharmasite Research, Inc. Baltimore Maryland
Dana Farber Cancer Institute Boston Massachusetts
Breslin Cancer Center Lansing Michigan
Minnesota Oncology/Hematology PA Minneapolis Minnesota
Washington University Medical School City of Saint Peters Missouri
Washington University Medical School Creve Coeur Missouri
Freeman Cancer Institute Joplin Missouri
St Lukes Hospital Kansas City Missouri
Washington University Medical School St Louis Missouri
Washington University Medical School St Louis Missouri
Billings Clinic Billings Montana
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Icahn School of Medicine at Mount Sinai New York New York
Columbia University Medical Center New York New York
Rochester General Hospital Rochester New York
Rochester General Hospital Rochester New York
Novant Health, Oncology Research Institute Winston-Salem North Carolina
Oklahoma Cancer Specialists & Research Institute, LLC Tulsa Oklahoma
Sanford Research/USD Sioux Falls South Dakota
The Boston Baskin Cancer Group Memphis Tennessee
SMO Sarah Cannon Research Inst. Nashville Tennessee
Baylor College of Medicine Houston Texas
Oncology Consultants P.A. Houston Texas

+ 106 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile →

More Eli Lilly and Company trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02107703 on ClinicalTrials.gov ↗ ← All trials in China