At a glance
ClinicalIndex Comparison RecordPhase 2Active· 234 enrolled
Drug / intervention
Abemaciclib +2 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, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Abemaciclib, Tamoxifen, and 1 other intervention for Metastatic Breast Cancer. Active but no longer recruiting, targeting 234 participants across 59 sites in 14 countries.
Detailed Summary
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesArgentina, Austria, Belgium, Brazil, Czechia, France, Germany, Italy, Mexico, Russia, Spain, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2Active
20172018201920202021202220232024202520262027
First PostedApr 2016
Enrollment StartSep 2016
Primary CompletionJun 2018
TodayJul 2026
Study CompletionDec 2026
First PostedApr 21, 2016
Enrollment StartSep 14, 2016
Primary CompletionJun 15, 2018
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago
Interventions
Abemaciclibdrug
Administered orally
Tamoxifendrug
Administered orally
Prophylactic Loperamidedrug
Administered orally