A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-Free Survival (PFS) — From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Trial sites (146)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
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 Italy