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A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

NCT04296370 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2020-08-10

No results posted yet for this study

Summary

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Conditions

  • Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

Interventions

DRUG

Fluzoparib; Apatinib

Fluzoparib Orally twice daily; Apatinib Orally once daily

DRUG

Fluzoparib

Fluzoparib Orally twice daily

DRUG

Physician's choice chemotherapy

Investigators will declare one of the following regimens: Capecitabine Vinorelbine

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-06-30
Completion
2025-06-30

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 NCT04296370 on ClinicalTrials.gov