A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02826512
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    niraparib 300 mg QD continuously

Study Details

Patients with locally recurrent BRCA1-like, HER2-negative breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or patients with metastatic BRCA1-like, HER2-negative breast cancer that have received a maximum of one prior line of treatment for incurable disease will be treated with Niraparib until disease progression

Key Dates

Start date
May 15, 2018
Status verified
Jul 2022
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

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

Arms

  • Experimental: Niraparib
    niraparib 300 mg QD continuously

Primary Outcome Measure

Progression free survival [ Time Frame: From date of randomization until date of first documented progression or date of death, whichever comes first, assessed up to 120 months ]

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