A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
试验速览
- 阶段
- 3 期
- 入组人数
- 332
- 试验地点
- 30
- 主要终点
- Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
研究概览
简要总结
This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •2.Histologically confirmed triple negative breast cancer. 3.Has at least one measurable lesion. 4.Newly diagnosed stage IV or recurrent/metastatic triple negative breast cancer who are not suitable for surgery.
- •5.Prior local radiotherapy for metastatic sites is allowed. 6.Adequate laboratory indicators. 7.Understood and signed an informed consent form. 8.No pregnant or breastfeeding women, and a negative pregnancy test.
排除标准
- •1.Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-
- •Severe hypersensitivity occurs after administration of other monoclonal antibodies.
- •Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
- •Has any active autoimmune disease or history of autoimmune disease.
- •Has a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonia, or active pneumonia.
- •Peripheral neuropathy ≥ grade
- •Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.
- •Has multiple factors affecting oral medication.
- •Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites.
- •Has any signs of bleeding or history.
- •Has unrelieved spinal cord compression.
- •Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.
- •Has received other anti-tumor therapy within 4 weeks before the first administration.
- •Has any serious and/or uncontrollable disease.
- •Has received vaccination or attenuated vaccine within 4 weeks before the first administration.
- •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
Paclitaxel for injection (albumin bound)
Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.
干预措施: Paclitaxel for Injection (albumin bound) (Drug)
TQB2450 + Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: TQB2450 (Drug)
TQB2450 + Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib (Drug)
结局指标
主要结局
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
时间窗: up to 96 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
次要结局
- Overall response rate (ORR)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Disease control rate（DCR）(up to 96 weeks)