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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
Clinical benefit rate (CBR)
The 6-months CBR is the measurement of all patients who have a complete response (CR), partial response (PR) or stable disease (SD), according to RECIST criteria v1.1. At six months, patients will be classified as success (Alive at 6 months AND CR/PR/ SD) or failure (dead OR alive with progression).
Time frame: at 6 months
Objective response rate (ORR)
The Objective response is defined as complete response (CR) or partial response (PR) according to RECIST criteria v1.1
Time frame: at 6 months
Duration of overall response (DoR)
The DoR is defined as the time from documentation of tumour response (CR/PR whichever is first recorded) to disease progression, according to RECIST criteria v1.1.
Time frame: at 6 months
Overall Survival (OS)
The OS is defined as the time from the first administration of abiraterone acetate to death from any cause.
Time frame: median follow-up = 2 years
Progression-free survival (PFS)
The PFS is defined as the time from the first administration of abiraterone acetate to progression or death of any cause, whichever occurs first.
Time frame: median follow-up = 2 years
Overall safety profile
The overall safety profile of the treatment is determined by the occurrence of adverse events and toxicities. The severity of the adverse events and toxicities will be graded according the NCI CTCAE scale version 4.0.
Time frame: during the on-treatment period (defined as the period from the time of first dose of study medications up to 30 days of the last dose)
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