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

2019-11-12 18:25:09 | BioPortfolio

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.

Description

The primary objective is to compare the efficacy of standard endocrine therapy + abemaciclib combination versus standard chemotherapy based on progression-free survival (PFS) within 24 weeks, 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)

Study Design

Conditions

Cancer Metastatic

Intervention

Paclitaxel injection, Capecitabine tablets, Letrozole 2.5mg, Anastrozole 1mg, Fulvestrant Prefilled Syringe, Abemaciclib

Status

Not yet recruiting

Source

UNICANCER

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-12T18:25:09-0500

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