Trial intelligence / Profile preview

START: Darolutamide in AR+ TNBC

NCT03383679Phase 2

Key facts

Status: Completed
Start: Mar 2018
Primary completion: Nov 2021
Countries: 1
Sponsor: Unicancer
Modality: Orthosteric Ligands

Drugs: darolutamide
Conditions: triple-negative breast cancer (TNBC)

Overview

Phase 2, randomised, open-label trial of darolutamide in triple-negative breast cancer (TNBC) (2 arms), sponsored by Unicancer. Primary endpoint: Clinical Benefit Rate at 16 weeks. Started Mar 2018; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Darolutamide
Darolutamide 600 mg twice daily
Capecitabine
Capecitabine 1000 mg/m2 twice daily (2 weeks on/1 week off)

Who it enrols

Women >= 18 with TNBC (ER/PgR <10%, HER2 neg) and AR+ (>=10%) locally recurrent or metastatic breast cancer. Max 1 prior chemo line for advanced disease. No prior capecitabine or AR inhibitors.

Endpoints

Primary

Clinical Benefit Rate16 weeks

Secondary

Clinical Benefit Rate24 weeks
Objective Response Rate24 weeks
Duration of Response24 weeks
Overall Survival2 years
Progression-Free Survival2 years
Adverse Eventsup to 100 months

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