MedTrace Logo

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

NCT05461690 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Niraparib

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Zhejiang University

    collaborator OTHER

  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Xiaojia Wang, MD · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-12-31
Completion
2025-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461690 on ClinicalTrials.gov