A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
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)
1 other identifier
interventional
332
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2020
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 28, 2020
May 1, 2020
2.1 years
May 24, 2020
May 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
up to 96 weeks
Secondary Outcomes (3)
Overall response rate (ORR)
up to 96 weeks
Disease control rate（DCR）
up to 96 weeks
Duration of Response (DOR)
up to 96 weeks
Study Arms (2)
TQB2450 + Anlotinib
EXPERIMENTALTQB2450 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)
ACTIVE COMPARATORPaclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.
Interventions
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
a anti-microtubule drug.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 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.
- 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.
You may not qualify if:
- 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.
- \. 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. 5. Has a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonia, or active pneumonia.
- \. 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.
- \. Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites.
- \. 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.
- \. Has received other anti-tumor therapy within 4 weeks before the first administration.
- \. Has any serious and/or uncontrollable disease. 15. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
The Fourth Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100038, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
The First Affilited Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510030, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
AnYang Tumor Hospital
Anyang, Henan, 455000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430061, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Yanbian University Hospital
Yanji, Jilin, 133000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110011, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
The Second Affiliated Hospital of PLA Airforce Military Medical University
Xi’an, Shanxi, 710032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, 641100, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
Xinjiang Uiger Municipal People's Hospital
Ürümqi, Xinjiang, 830000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2020
First Posted
May 28, 2020
Study Start
June 1, 2020
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
May 28, 2020
Record last verified: 2020-05