Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05461690
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    200mg once a day for patients with body weight \<77kg or baseline platelet count \<150,000/µL, and 300mg once a day for patients with body weight ≥ 77kg and baseline platelet count ≥ 150,000/µL until disease progression or intolerable toxicity whichever occurs first.

Study Details

The incidence of homologous recombination deficiency in metastatic triple negative breast cancer was 52%-59%，PARP plays a key role in sensing DNA damage and converting it into intracellular signals that activate the base excision repair (BER) and single-strand break repair pathways. Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a subset of cancer cells with deficiencies in DNA repair pathways. This is a multicenter, single-arm, phase II study evaluating the efficacy and safety of niraparib in patients with HRD positive metastatic triple negative breast cancer.

Key Dates

Start date
Sep 1, 2022
Status verified
Jul 2022
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

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

Arms

  • Experimental: Niraparib group
    200mg once a day for patients with body weight \<77kg or baseline platelet count \<150,000/µL, and 300mg once a day for patients with body weight ≥ 77kg and baseline platelet count ≥ 150,000/µL until disease progression or intolerable toxicity whichever occurs first.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. ]

Central Contacts

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