At a glance
ClinicalIndex Comparison RecordPhase 3Active· 463 enrolled
Drug / intervention
Abemaciclib +4 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 to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Abemaciclib, Anastrozole, and 3 other interventions for Breast Cancer. Active but no longer recruiting, targeting 463 participants across 45 sites in 4 countries.
Detailed Summary
The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBrazil, China, India, South Africa
Collaborators--
Timeline
Phase 3Active
201720182019202020212022202320242025202620272028
First PostedMay 2016
Enrollment StartDec 2016
Primary CompletionMar 2019
TodayJul 2026
Study CompletionMar 2028
First PostedMay 5, 2016
Enrollment StartDec 5, 2016
Primary CompletionMar 29, 2019
Study CompletionMar 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.2 years ago
Interventions
Abemaciclibdrug
Administered orally
Anastrozoledrug
Administered orally
Letrozoledrug
Administered orally
Placebodrug
Administered orally
Fulvestrantdrug
Administered intramuscularly