A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature

Sponsor
UNICANCER
Study ID
NCT02505048
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • rucaparib — DRUG
    600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.

Study Details

The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.

Key Dates

Start date
Mar 31, 2016
Status verified
Jun 2021
Primary completion
Feb 28, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rucaparib
    Tablets 200 mg and 300 mg per os : 600 mg / bid every day in continuous. Patients will be treated with rucaparib Cycles are defined in 28-day periods Disease response will be assessed every 8 weeks (RECIST 1.1) Safety will be assessed continuously

Primary Outcome Measure

Clinical Benefit Rate [ Time Frame: 3 years ]

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