Clinical Trial

Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer

Study acronym: AMBRE
Active, Not Recruiting Phase 3
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Summary
AMBRE is a phase III study comparing two standard treatments as initial metastatic treatment in ER+/HER2- breast cancer (BC) patients with visceral metastasis and high burden disease: Chemotherapy and combination of endocrine therapy with abemaciclib.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-11-06; most recent amendment 2026-07-21.
Status change: Recruiting → Active, Not Recruiting 2024-09-12
Status change: Suspended → Recruiting 2020-06-15
Status change: Not Yet Recruiting → Suspended 2020-04-17
Trial Details
NCT Number NCT04158362
Lead Sponsor UNICANCER
Conditions Cancer Metastatic
Enrollment 180 participants
Start Date 2020-06-11
Primary Completion 2025-04-30 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-22