Actively Recruiting
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-08-15
200
Participants Needed
1
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets. The trial aims at extending the combination target therapy involving PARP inhibitors and anti-angiogenesis from only BRCA mutation carriers to all patients with homologous recombination repair defects (HRD-positive). The phase III randomized clinical study will investigate the effectiveness of the combination therapy of PARP inhibitor "fludzoparib" and anti-angiogenic "apatinib" in treating HRD-positive/HER2-negative advanced breast cancers.
CONDITIONS
Official Title
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years with metastatic breast cancer confirmed by pathology or imaging
- Pathological confirmation that breast cancer is HER2 negative
- Positive HRD test result (BRCA1/2 mutation or HRD score 6)
- HR+/HER2- patients who have received endocrine therapy during metastasis
- No more than two prior chemotherapy or antibody-drug conjugate regimens for metastatic breast cancer
- Anti-tumor treatment response showing clinical benefit or stable disease for at least 24 weeks
- ECOG performance status of 0 to 2 and expected survival of at least 3 months
- At least one measurable lesion or simple bone metastasis seen on imaging within 2 weeks before enrollment
- Previous treatment-related toxicities resolved to grade 1 or less (except alopecia or non-risk toxicities)
- Adequate bone marrow function with WBC 10^9/L, ANC 1.5�010^9/L, and platelets 7�010^9/L
- Normal liver, kidney, and heart function within specified limits
- Ability to understand the study and provide informed consent
You will not qualify if you...
- HR+/HER2- metastatic breast cancer patients who have not received endocrine therapy
- No prior treatment for metastatic breast cancer
- More than two prior chemotherapy regimens for metastatic breast cancer
- Known allergy to study drugs or their ingredients
- Pregnant or breastfeeding women, or women not using contraception during the study
- Severe heart disease or symptoms that would prevent chemotherapy tolerance
- Other medical conditions or infections that could interfere with study participation or safety, such as uncontrolled hypertension or active infections
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat Sen Memorial Hospital，Sun Yat sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Z
Zhao Jianli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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