A Randomized, Open-label, Controlled, Multicenter Phase III Study of Fluorizoparib in Combination With Apatinib Versus Investigator's Choice Chemotherapy in Patients With HRD-positive, HER2-negative Advanced Breast Cancer
A Randomized, Open-label, Controlled, Multicenter Phase III Study of Fluorizoparib in Combination With Apatinib Versus Investigator's Choice Chemotherapy in Patients With HRD-positive, HER2-negative Advanced Breast Cancer
This is a Phase III clinical trial for patients with a specific type of advanced breast cancer that is HER2-negative and has a biomarker called "Homologous Recombination Deficiency (HRD)-positive."
The study aims to compare the effectiveness and safety of two treatment strategies:
Experimental Group: Patients will first receive 6 cycles of standard chemotherapy or antibody-drug conjugate (ADC) therapy chosen by their doctor. After completing these 6 cycles, they will switch to a combination of two oral targeted drugs: Fluorizoparib and Apatinib, as long-term maintenance therapy.
Control Group: Patients will continue to receive their doctor's choice of standard chemotherapy or ADC therapy without switching to the targeted drug combination.
Patients will be randomly assigned (like flipping a coin) to one of the two groups.
Inclusion Criteria:
Histologically confirmed HER2-negative metastatic breast cancer.
Documented HRD-positive status (defined as BRCA1/2 mutation and/or HRD positive).
HR+/HER2- patients must have received prior endocrine therapy for metastatic disease.
Have received no more than 2 prior lines of chemotherapy or ADC therapy for metastatic disease.
At least one measurable lesion per RECIST 1.1.
ECOG performance status 0-2 and life expectancy ≥3 months.
Adequate organ function (bone marrow, liver, renal, cardiac).
Exclusion Criteria:
Have not received any prior systemic therapy for metastatic breast cancer.
Have received >2 prior lines of chemotherapy or ADC therapy for metastatic disease.
Known severe hypersensitivity to any component of the study drugs.
Pregnant, lactating, or women of childbearing potential unwilling to use effective contraception.
Uncontrolled or significant cardiovascular disease.
Any other condition deemed inappropriate for the study by the investigato