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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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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