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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Physician's choice chemotherapy; Drug: Fluzoparib; Apatinib; Drug: Fluzoparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04296370

FZPL-Ⅲ-303

Details and patient eligibility

About

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.

Enrollment: 474 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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474 participants in 3 patient groups

Safety Lead-in, Doublet Arm

Experimental group

Description:

Fluzoparib+Apatinib

Treatment:

Drug: Fluzoparib; Apatinib

Single Arm

Experimental group

Description:

Fluzoparib

Treatment:

Drug: Fluzoparib

Physician's choice chemotherapy

Active Comparator group

Description:

Capecitabine or Vinorelbine

Treatment:

Drug: Physician's choice chemotherapy