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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead-in, Doublet Arm | Experimental | Fluzoparib+Apatinib |
|
| Single Arm | Experimental | Fluzoparib |
|
| Physician's choice chemotherapy | Active Comparator | Capecitabine or Vinorelbine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib; Apatinib | Drug | Fluzoparib Orally twice daily; Apatinib Orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Safety Lead-in) dose limited toxicity (DLT) | dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle | up to 21 days |
| (Safety Lead-in) Recommended Phase II Dose (RP2D) | Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib | up to 21 days |
| (Phase 3) Progression free survival(PFS) in HER2-negative Metastatic Breast Cancer patients | Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria | Radiological scans performed at baseline then every ~6 weeks up to 30 weeks, then every ~ 9 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 30 days for the last treatment dose |
| PFS by investigator's assessment | Progression-Free-Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41308673 | Derived | Li H, Liu J, Ouyang Q, Wang S, Liu Y, Teng Y, Wang X, Cheng J, Tong Z, Sun T, Yan M, Zhou X, Li F, Nie J, Shao ZM, Ye C, Wang Y, Wu X, Li Z, Wu Y, Xiong H, Li H, Gan L, Niu Z, Zhang J, Zhang Q, Pan Y, Wu X, Zhang Y, Xie W, Xiao Y, Gao J, Zhao H, Yin Y, Qian Z, Sun S, Zhang H, Wang K, Lu J, Li Y, Wang X, Yang X, Wang Y, Wang Q, Song E. Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1563-1574. doi: 10.1016/S1470-2045(25)00523-6. |
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| Fluzoparib | Drug | Fluzoparib Orally twice daily |
|
| Physician's choice chemotherapy | Drug | Investigators will declare one of the following regimens: Capecitabine Vinorelbine |
|
| up to 30 months |
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 30 months |
| Patient Reported Outcomes (PROs) assessed by EORTC QLQ C30 questionnaire | Comparison of the Quality of Life in study arms assessed by EORTC QLQ C30 questionnaire | up to 30 months |
| Time to progression on the next anticancer therapy (PFS2) | From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first | up to 30 months |
| Objective Response Rate (ORR) | Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI | up to 30 months |
| Disease control rate (DCR) | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 | up to 30 months |
| Duration of response (DoR) | Time from documentation of tumor response to disease progression assessed among patients who had an objective response | up to 30 months |
| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| C553458 | apatinib |
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