NCT04158362

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

Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Burden Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to compare the efficacy of standard endocrine therapy + abemaciclib combination versus standard chemotherapy based on progression-free survival (PFS), in patients with visceral metastases of ER+/HER2- breast cancer and high tumor burden. Patients will be randomly assigned to receive either: * Standard chemotherapy regimen physician's choice either (paclitaxel or capecitabine) * Standard endocrine therapy regimen physician's choice + abemaciclib (Letrozole or anastrozole for patients nonsteroidal aromatase inhibitor (NSAI) naïve or relapsing \>1 year after the end of adjuvant endocrine therapy, and fulvestrant for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI)

Conditions

• Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Paclitaxel injection	Paclitaxel is administrated at the dose of 80 mg/m² as a 1-hour intravenous infusion every week (i.e., D1, D8 and D15) of a 3-week cycle
DRUG	Capecitabine tablets	Capecitabine is given orally at a dose of 2000 to 2500 mg/m² daily for 14 days followed by a 7-day rest period every 3 weeks
DRUG	Letrozole 2.5mg	Letrozole is administered orally at 2.5 mg/day continuous for patients nonsteroidal aromatase inhibitor naïve or relapsing \>1 year after the end of adjuvant endocrine therapy.
DRUG	Anastrozole 1mg	Anastrozole is administered orally at 1 mg/day continous for patients nonsteroidal aromatase inhibitor (NSAI) naïve or relapsing \>1 year after the end of adjuvant endocrine therapy.
DRUG	Fulvestrant Prefilled Syringe	Fulvestrant is administered at the dose of 500 mg intramuscular on D1-D15-D29 (as a loading dose), and then 500 mg every 28 days (as a maintenance dose) for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI.
DRUG	Abemaciclib	Oral 150 mg BID continuous

Timeline

• Start date: 2020-06-11
• Primary completion: 2025-04-30
• Completion: 2028-06-01
• First posted: 2019-11-08
• Last updated: 2025-09-22

Locations

2 sites across 1 country: France