Clinical Trials /

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

NCT04296370

Description:

This is a multicenter, randomized, blinded, 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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
  • Official Title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib±Apatinib Versus Physicians Choice Chemotherapy in the Treatment of HER2-negative Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations

Clinical Trial IDs

  • ORG STUDY ID: FZPL-Ⅲ-303
  • NCT ID: NCT04296370

Conditions

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

Interventions

DrugSynonymsArms
Fluzoparib; ApatinibSafety Lead-in, Doublet Arm
FluzoparibSingle Arm
Physician's choice chemotherapyPhysician's choice chemotherapy

Purpose

This is a multicenter, randomized, blinded, 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.

Trial Arms

NameTypeDescriptionInterventions
Safety Lead-in, Doublet ArmExperimentalFluzoparib+Apatinib
  • Fluzoparib; Apatinib
Single ArmExperimentalFluzoparib
  • Fluzoparib
Physician's choice chemotherapyActive ComparatorCapecitabine or Vinorelbine
  • Physician's choice chemotherapy

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
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:(Safety Lead-in) dose limited toxicity (DLT)
Time Frame:up to 21 days
Safety Issue:
Description:dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle

Secondary Outcome Measures

Measure:AEs+SAEs
Time Frame:from the first drug administration to within 30 days for the last treatment dose
Safety Issue:
Description:Adverse Events and Serious Adverse Events
Measure:PFS by investigator's assessment
Time Frame:up to 30 months
Safety Issue:
Description:Progression-Free-Survival
Measure:OS
Time Frame:up to 30 months
Safety Issue:
Description:OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Measure:Patient Reported Outcomes (PROs) assessed by EORTC QLQ C30 questionnaire
Time Frame:up to 30 months
Safety Issue:
Description:Comparison of the Quality of Life in study arms assessed by EORTC QLQ C30 questionnaire
Measure:Time to progression on the next anticancer therapy (PFS2)
Time Frame:up to 30 months
Safety Issue:
Description:From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first
Measure:Objective Response Rate (ORR)
Time Frame:up to 30 months
Safety Issue:
Description:Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Measure:Disease control rate (DCR)
Time Frame:up to 30 months
Safety Issue:
Description:Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Measure:Duration of response (DoR)
Time Frame:up to 30 months
Safety Issue:
Description:Time from documentation of tumor response to disease progression assessed among patients who had an objective response

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

Last Updated

March 3, 2020