A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT04405505
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 332
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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.
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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-4.
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Severe hypersensitivity occurs after administration of other monoclonal antibodies.
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Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
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Has any active autoimmune disease or history of autoimmune disease. 5. Has a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonia, or active pneumonia.
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Peripheral neuropathy ≥ grade 2. 7. 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.
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Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites.
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Has any signs of bleeding or history. 11. Has unrelieved spinal cord compression. 12. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.
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Has received other anti-tumor therapy within 4 weeks before the first administration.
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Has any serious and/or uncontrollable disease. 15. Has received vaccination or attenuated vaccine within 4 weeks before the first administration.
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According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQB2450 + Anlotinib TQB2450 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). Paclitaxel for injection (albumin bound) Paclitaxel for Injection (albumin bound) Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle. TQB2450 + Anlotinib 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).
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) evaluated by Independent Review Committee(IRC) 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.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) up to 96 weeks DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Disease control rate（DCR） up to 96 weeks Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Overall response rate (ORR) up to 96 weeks Percentage of participants achieving complete response (CR) and partial response (PR).
Trial Locations
- Locations (30)
The Fourth Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The First Affilited Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi Zhuang Autonomous Region, China
Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
AnYang Tumor Hospital
🇨🇳Anyang, Henan, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Yanbian University Hospital
🇨🇳Yanji, Jilin, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Shanxi Provincial People's Hospital
🇨🇳Xi'an, Shanxi, China
The Second People's Hospital of Neijiang
🇨🇳Neijiang, Sichuan, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Xinjiang Uiger Municipal People's Hospital
🇨🇳Urumqi, Xinjiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Shijitan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi Zhuang Autonomous Region, China
The fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital of PLA Airforce Military Medical University
🇨🇳Xi'an, Shanxi, China