A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 17
- 主要终点
- Overall response rate (ORR) assessed by investigator
研究概览
简要总结
This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer. 4.Cohort 1: patients had received ≤1 line of treatment. 5.Cohort 2: patients had not previously received systemic antitumor therapy. 6.Has at least one measurable lesion according to RECIST1.1 criteria. 7.Adequate laboratory indicators.
排除标准
- •Concomitant disease and medical history:
- •Has other malignant tumors within 3 years;
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
- •Has active or uncontrolled severe infections before the first dose;
- •Cirrhosis, active hepatitis#
- •Have a history of immunodeficiency;
- •Tumor-related symptoms and treatment:
- •Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
- •Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose;
- •Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.
- •Has Participated in other clinical trials within 4 weeks before first dose.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB3616 capsules combined with fulvestrant injection
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle. Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.
干预措施: TQB3616 capsules (Drug)
TQB3616 capsules combined with fulvestrant injection
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle. Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.
干预措施: Fulvestrant injection (Drug)
结局指标
主要结局
Overall response rate (ORR) assessed by investigator
时间窗: Baseline up to 24 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.
次要结局
- Progression free survival (PFS)(Baseline up to 24 months)
- Duration of Response (DOR)(Baseline up to 24 months)
- Overall survival (OS)(Baseline up to 24 months])
- Clinical benefit rate (CBR)(Baseline up to 24 months)