Description:
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.
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
| Drug | Synonyms | Arms |
|---|
| Fluzoparib; Apatinib | | Safety Lead-in, Doublet Arm |
| Fluzoparib | | Single Arm |
| Physician's choice chemotherapy | | Physician's choice chemotherapy |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Safety Lead-in, Doublet Arm | Experimental | Fluzoparib+Apatinib | |
| Single Arm | Experimental | Fluzoparib | |
| Physician's choice chemotherapy | Active Comparator | Capecitabine 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: | Recruiting |
| Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
Last Updated
August 10, 2020
