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Study on Androgen Receptor and Triple Negative Breast Cancer

NCT03383679 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2022-11-21

No results posted yet for this study

Summary

This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2.

The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.

Conditions

  • Breast Cancer Female
  • Triple Negative and Androgen Receptor Positive

Interventions

DRUG

Darolutamide

treatment with darolutamide

DRUG

Capecitabine

treatment with capecitabine

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Hervé BONNEFOI, MD · Institut Bergonié - University of Bordeaux 2

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2021-11-30
Completion
2022-07-20

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383679 on ClinicalTrials.gov