NCT01842321

Abiraterone Acetate in Molecular Apocrine Breast Cancer

A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.

Detailed description

Screening : All women 18+, with a confirmed locally advanced or metastatic Triple Negative Breast Cancer (TNBC), will be screened and invited to participate (300-500 patients). Only patients with a centralized confirmation of ER-/PR-/HER2- and evaluation of AR+ will be included and treated with abiraterone acetate plus prednisone (31 patients). The Treatment phase comprises a series of 4 weeks-cycles with continuous study treatment. Study drug treatment will continue until the earliest of the following events: disease progression, unacceptable toxicity, or death. At disease progression, patients must be discontinued from study drug and should be evaluated within 30 days during the Post treatment visit and then entered into the Follow-Up phase.Patients should enter the Follow-Up Period regardless of reason for study drug discontinuation and should be monitored every 3 months (± 7 days) during 2 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Patients will receive abiraterone acetate at 1,000 mg (four 250 mg tablets daily in the morning after an overnight fast) concurrently with prednisone(1) at 10 mg once daily.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-07-15
• Completion: 2018-07-04
• First posted: 2013-04-29
• Last updated: 2021-02-23

Locations

36 sites across 1 country: France