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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
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-06-12
Completion Date
2031-03
Last Updated
2025-08-15
Healthy Volunteers
No
Interventions
Fluzoparib
Fluzoparib capsules appropriate dose oral, each treatment cycle defined as 3 weeks (21 days).
Apatinib Mesylate
Apatinib Mesylate oral; each treatment cycle defined as 3 weeks (21 days).
Capecitabine tablets
Capecitabine tablets, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
Vinorelbine Tartrate Oral
For the first three courses: reasonable dosage with reference to guidelines. After 3 courses of medication, it is recommended to increase the dose of vinorelbine tartrate once a week. Each treatment cycle defined as 3 weeks (21 days).
Eribulin mesylate injection
Eribulin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
Gemcitabine Hydrochloride
Gemcitabine, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
Paclitaxel-albumin
Paclitaxel-albumin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).
Locations (1)
Sun Yat Sen Memorial Hospital,Sun Yat sen University
Guangzhou, Guangdong, China