At a glance
ClinicalIndex Comparison RecordPhase 3Active· 493 enrolled
Drug / intervention
Abemaciclib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
In Brief
A Phase 3 clinical trial evaluating Abemaciclib, Anastrozole, and 2 other interventions for Breast Cancer. Active but no longer recruiting, targeting 493 participants across 155 sites in 22 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
2015201620172018201920202021202220232024202520262027
First PostedSep 2014
Enrollment StartNov 2014
Primary CompletionJan 2017
TodayJul 2026
Study CompletionDec 2026
First PostedSep 23, 2014
Enrollment StartNov 6, 2014
Primary CompletionJan 31, 2017
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.8 years ago
Interventions
Abemaciclibdrug
Administered orally
Anastrozoledrug
Administered orally
Letrozoledrug
Administered orally
Placebodrug
Administered orally