PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05232006
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

Eligibility Criteria

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

Interventions

Study Details

The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers. This study is designed as a multicentre one-arm two-stage phase 2 clinical trial

Key Dates

Start date
May 31, 2022
Status verified
Jan 2022
Primary completion
Sep 30, 2024
Completion
May 31, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib
    PARP-inhibitor, Niraparib Dosage : starting 300 mg/day for patients with body weight ≥77kg and platelet counts ≥ 150 000/µl or 200 mg when body weight inferior to 77kg and/or platelet counts ≤ 150 000/µl and \> 100 000/µl Pharmaceutical form : 100 mg capsules Posology : single dose daily Route of administration : oral Administration procedures : oral, daily single dose Duration of treatment : 12 cycles of 28 days each

Primary Outcome Measure

Objective response rate [ Time Frame: 4 months ]

Central Contacts