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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-70 years.
- •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.
- •ECOG performance status 0-2 and life expectancy ≥3 months.
- •Adequate organ function (bone marrow, liver, renal, cardiac).
排除标准
- •HR+/HER2- patients who have not received prior endocrine therapy for metastatic disease.
- •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
研究组 & 干预措施
Sequential Fluorizoparib + Apatinib after Chemotherapy/ADC
This is the experimental arm. Participants receive a two-phase sequential treatment strategy:
Induction Phase: 6 cycles of investigator-selected chemotherapy or ADC therapy.
Maintenance Phase: Participants who complete induction without disease progression switch to long-term oral maintenance therapy with the combination of Fluorizoparib and Apatinib.
Treatment continues until disease progression, unacceptable toxicity, withdrawal, or death.
干预措施: Chemotherapy/ADC Regimen (Drug)
Sequential Fluorizoparib + Apatinib after Chemotherapy/ADC
This is the experimental arm. Participants receive a two-phase sequential treatment strategy:
Induction Phase: 6 cycles of investigator-selected chemotherapy or ADC therapy.
Maintenance Phase: Participants who complete induction without disease progression switch to long-term oral maintenance therapy with the combination of Fluorizoparib and Apatinib.
Treatment continues until disease progression, unacceptable toxicity, withdrawal, or death.
干预措施: Fluorizoparib (Drug)
Sequential Fluorizoparib + Apatinib after Chemotherapy/ADC
This is the experimental arm. Participants receive a two-phase sequential treatment strategy:
Induction Phase: 6 cycles of investigator-selected chemotherapy or ADC therapy.
Maintenance Phase: Participants who complete induction without disease progression switch to long-term oral maintenance therapy with the combination of Fluorizoparib and Apatinib.
Treatment continues until disease progression, unacceptable toxicity, withdrawal, or death.
干预措施: Apatinib (Drug)
Physician's Choice Chemotherapy/ADC Regimen
This is the control arm intervention. 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.
干预措施: Physician's Choice Chemotherapy/ADC Regimen (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
时间窗: From randomization until disease progression or death (assessed up to approximately 4 years).
次要结局
- Objective Response Rate (ORR)(From randomization until first documented response or progression (assessed every 6-8 weeks during treatment, up to approximately 2 years))
- Overall Survival (OS)(From randomization until death from any cause (assessed up to approximately 7 years, which is the total study duration))
- Clinical Benefit Rate (CBR)(From randomization until progression or 24 weeks of stable disease (assessed up to approximately 2 years).)
- Disease Control Rate (DCR)(From randomization until the end of treatment or progression (assessed up to approximately 2 years))