A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr

Sponsor
Institut Paoli-Calmettes
Study ID
NCT05519670
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.

Key Dates

Start date
Mar 31, 2023
Status verified
Aug 2022
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Only Arm
    niraparib + capecitabine treatment

Primary Outcome Measure

Dose-Limiting Toxicities (DLT) [ Time Frame: 3 weeks ]

Central Contacts

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