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

NCT ID: NCT04296370

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety Lead-in, Doublet Arm

Fluzoparib+Apatinib

Group Type: EXPERIMENTAL

Fluzoparib; Apatinib

Intervention Type: DRUG

Fluzoparib Orally twice daily; Apatinib Orally once daily

Single Arm

Fluzoparib

Group Type: EXPERIMENTAL

Fluzoparib

Intervention Type: DRUG

Fluzoparib Orally twice daily

Physician's choice chemotherapy

Capecitabine or Vinorelbine

Group Type: ACTIVE_COMPARATOR

Physician's choice chemotherapy

Intervention Type: DRUG

Investigators will declare one of the following regimens:

Capecitabine Vinorelbine

Interventions

Fluzoparib; Apatinib

Fluzoparib Orally twice daily; Apatinib Orally once daily

Intervention Type: DRUG

Fluzoparib

Fluzoparib Orally twice daily

Intervention Type: DRUG

Physician's choice chemotherapy

Investigators will declare one of the following regimens:

Capecitabine Vinorelbine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• （Saftey Lead-in + phase 3）Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
• （Saftey Lead-in + phase 3）human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer
• （Saftey Lead-in + phase 3）had received ≤2 lines of chemotherapy for mBC
• （Saftey Lead-in + phase 3）Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
• ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
• ECOG performance status 0-1.
• Adequate bone marrow, kidney and liver function.

Exclusion Criteria

• Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
• Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed
• Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
• Known to be human immunodeficiency virus positive
• Known active hepatitis C virus, or known active hepatitis B virus
• Untreated and/or uncontrolled brain metastases
• Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu HengRui Medicine Co., Ltd.

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Quanren Wang

Role: primary

wangquanren@hrglobe.cn

+86 18036618570

Xiaodi Wang

Role: backup

wangxiaodi@hrglobe.cn

+86 13811442099

Other Identifiers

FZPL-Ⅲ-303

Identifier Type: -

Identifier Source: org_study_id