A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Abemaciclib: Administered orally
Anastrozole: Administered orally
Letrozole: Administered orally
Placebo: Administered orally
Study summary
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by 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 (155)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | |
| Highlands Oncology Group | Springdale | Arkansas | |
| CBCC Global Research, Inc. | Bakersfield | California | |
| California Cancer Associates Research and Excellence | Fresno | California | |
| TRIO-US (Translational Research in Oncology-US) | Los Angeles | California | |
| Central Coast Medical Oncology Corporation | Los Angeles | California | |
| Orlando Health, Inc | Los Angeles | California | |
| North Valley Hematology/Oncology Medical Group | Los Angeles | California | |
| UCLA Hematology/Oncology - Parkside | Santa Monica | California | |
| Holy Cross Hospital | Fort Lauderdale | Florida | |
| Lakes Research, LLC | Miami Lakes | Florida | |
| Candler Medical Oncology Practice - Statesboro | Savannah | Georgia | |
| Candler Medical Oncology Practice - Statesboro | Savannah | Georgia | |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | |
| Nebraska Hematology-Oncology, P.C. | Lincoln | Nebraska | |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | |
| Mount Sinai Cancer Center | New York | New York | |
| University of Tennessee Medical Center | Knoxville | Tennessee | |
| Oncology Consultants P.A. | Houston | Texas | |
| Joe Arrington Cancer Center | Lubbock | Texas | |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | |
| St Vincent's Hospital | Sydney | New South Wales | |
| Sydney Adventist Hospital | Wahroonga | New South Wales | |
| Mater Adult Hospital Brisbane | South Brisbane | Queensland | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| The Queen Elizabeth Hospital | Woodville | South Australia | |
| Barwon Health - The Geelong Hospital | Geelong | Victoria | |
| St. John of God Murdoch Hospital | Murdoch | Western Australia | |
| Medizinische Universität Wien | Vienna | State of Vienna | |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | State of Vienna | |
| Medizinische Universitaet Graz | Graz | Styria | |
| Medizinische Universitaet Innsbruck | Innsbruck | Tyrol | |
| Ordensklinikum Linz | Linz | Upper Austria | |
| Iridium Kankernetwerk Wilrijk en Antwerp | Wilrijk | Antwerpen | |
| Cliniques universitaires Saint-Luc | Brussels | Brussels Capital | |
| Institut Jules Bordet | Anderlecht | Bruxelles-Capitale, Région de | |
| Grand Hopital de Charleroi-Site Notre-Dame | Charleroi | Belgium | |
| CHU UCL Namur/Site Sainte Elisabeth | Namur | Belgium | |
| AZ Delta | Roeselare | Belgium | |
| Cross Cancer Institute | Edmonton | Alberta |
+ 115 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 NCT02246621 on ClinicalTrials.gov ↗ ← All trials in Italy