drugset
drugset / Trial / NCT04158362

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

NCT04158362 ↗

Phase 3 Active not recruiting 180 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-06-11
Primary completion
2025-04-30
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 150 mg Oral
Subject Anastrozole Other / unclassified 1 mg Oral
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Subject Capecitabine Small molecule 2500 mg/m2 Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications

metastatic malignant neoplasm