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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
This is the initial induction phase of the experimental arm. Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from protocol-specified options (e.g., eribulin, vinorelbine, gemcitabine, capecitabine, sacituzumab govitecan, or trastuzumab deruxtecan). Administration follows the standard schedule of the chosen agent. The purpose is to achieve disease control before switching to long-term maintenance therapy.
This oral PARP inhibitor is administered as part of the maintenance phase. Participants who complete the 6-cycle induction phase without disease progression switch to Fluorizoparib twice daily in continuous 21-day cycles, in combination with Apatinib, until disease progression or unacceptable toxicity.
This oral anti-angiogenic TKI is administered as part of the maintenance phase. Participants who complete the 6-cycle induction phase without disease progression switch to Apatinib once daily in continuous 21-day cycles, in combination with Fluorizoparib, until disease progression or unacceptable toxicity.
Participants receive continuous treatment with a standard chemotherapy regimen or an Antibody-Drug Conjugate (ADC) selected by the investigator from protocol-specified options (e.g., eribulin, vinorelbine, gemcitabine, capecitabine, sacituzumab govitecan, or trastuzumab deruxtecan). Treatment is administered intravenously or orally according to the standard schedule of the chosen agent and continues without a planned switch to the oral targeted combination therapy, until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Time frame: From randomization until disease progression or death (assessed up to approximately 4 years).
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
The time from randomization to the first documented disease progression according to RECIST 1.1 criteria, or death from any cause, whichever occurs first.
Time frame: From randomization until disease progression or death (assessed up to approximately 4 years).
Objective Response Rate (ORR)
Time frame: From randomization until first documented response or progression (assessed every 6-8 weeks during treatment, up to approximately 2 years)
Overall Survival (OS)
Time frame: From randomization until death from any cause (assessed up to approximately 7 years, which is the total study duration)
Clinical Benefit Rate (CBR)
Time frame: From randomization until progression or 24 weeks of stable disease (assessed up to approximately 2 years).
Disease Control Rate (DCR)
Time frame: From randomization until the end of treatment or progression (assessed up to approximately 2 years)
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