Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination W… (NCT06255392) | Clinical Trial Compass
RecruitingPhase 3
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
China200 participantsStarted 2024-06-12
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. White blood cell count (WBC) ≥3.0×10\^9 / L
✓. Neutrophil count (ANC) ≥1.5×10\^9 / L
✓. Platelet count (PLT) ≥70×10\^9 / L 11) Liver, kidney and heart function tests are basically normal (based on the normal values in the laboratories of each research center) :
Exclusion criteria
✕. Patients with HR+/ HER2-MBC who have not received endocrine therapy before;
✕. Has not received any treatment for metastatic breast cancer;
✕. Received more than two chemotherapy regimens for metastatic breast cancer;
✕. Patients who are known to be allergic to the active ingredient or other ingredients of the investigational drug.
✕. Pregnant or lactating women, and women of childbearing age who refused to take effective contraceptive measures during the study period.
✕. Those with severe heart disease or discomfort, expected to be unable to tolerate chemotherapy, including but not limited to: fatal arrhythmia or higher-grade atrioventricular block, unstable angina pectoris, clinically significant valvular heart disease, electrocardiogram showing transmural myocardial infarction, uncontrollable hypertension;
✕. Any other circumstances where the researcher deems the patient unsuitable for participation in this study, any concomitant diseases or conditions that may interfere with participation in the study, or any serious medical conditions that may affect the safety of the subjects (such as uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection).