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Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer

NCT05834582 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-28

No results posted yet for this study

Summary

Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.

Conditions

  • TNBC - Triple-Negative Breast Cancer

Interventions

DRUG

Fluzoparib+Paclitaxel

Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy

DRUG

Epirubicin+Cyclophosphamide

Epirubicin+Cyclophosphamide

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Xiaoan Liu, Professor · Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-08
Primary Completion
2025-06-01
Completion
2026-06-01

Countries

  • China

Study Locations

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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 NCT05834582 on ClinicalTrials.gov