Comparing Fluzoparib and Apatinib to Chemotherapy for HER2-negative Breast Cancer with BRCA Mutation
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
This study is testing whether a new combination of Fluzoparib and Apatinib can help people with HER2-negative breast cancer and a BRCA mutation do better than standard chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | Apatinib, chemotherapy, Radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04296370 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, open-label Phase 3 study evaluates the efficacy and safety of Fluzoparib alone or in combination with Apatinib compared to physician's choice chemotherapy in patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation. The study includes a Safety Lead-in Phase to assess the safety and tolerability of the combination treatment before proceeding to the main Phase 3 portion. Patients will be monitored for treatment outcomes and side effects throughout the study.
Who should consider this trial
Good fit: Ideal candidates include patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and have received two or fewer lines of chemotherapy.
Not a fit: Patients who have previously been treated with a PARP inhibitor or Apatinib may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with HER2-negative metastatic breast cancer and BRCA mutations.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly in targeting BRCA mutations in breast cancer, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Jiangsu HengRui Medicine Co., Ltd. — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.