Back to resultsA Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
Primary Purpose
Triple Negative Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TQB2450
Anlotinib
Paclitaxel for Injection (albumin bound)
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
2. Severe hypersensitivity occurs after administration of other monoclonal antibodies.
3. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
4. 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.
6. 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.
8. Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites.
10. 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.
13. Has received other anti-tumor therapy within 4 weeks before the first administration.
14. Has any serious and/or uncontrollable disease. 15. Has received vaccination or attenuated vaccine within 4 weeks before the first administration.
16. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Sites / Locations
- The Fourth Affiliated Hospital of Anhui Medical University
- Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
- Beijing Shijitan Hospital Affiliated to Capital Medical University
- Beijing Tsinghua Changgung Hospital
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Chongqing Cancer Hospital
- The First Affilited Hospital of Chongqing Medical University
- Guangdong Provincial People's Hospital
- Guangxi Medical University Affiliated Tumor Hospital
- The First Affiliated Hospital of Guangxi Medical University
- The fourth Hospital of Hebei Medical University
- Affiliated Tumor Hospital of Harbin Medical University
- AnYang Tumor Hospital
- Zhongnan Hospital of Wuhan University
- Hunan Cancer Hospital
- Nantong Tumor Hospital
- The First Hospital of Jilin University
- Yanbian University Hospital
- The First Hospital of China Medical University
- Liaoning Cancer Hospital & Institute
- Qilu Hospital of Shandong University
- Shanxi Cancer Hospital
- The Second Affiliated Hospital of PLA Airforce Military Medical University
- The First Affiliated Hospital of Xi'an Jiaotong University
- Shanxi Provincial People's Hospital
- The Second People's Hospital of Neijiang
- Tianjin Cancer Hospital
- Xinjiang Uiger Municipal People's Hospital
- Zhejiang Cancer Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TQB2450 + Anlotinib
Paclitaxel for injection (albumin bound)
Arm Description
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) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Full Information
NCT ID
NCT04405505
First Posted
May 24, 2020
Last Updated
May 24, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04405505
Brief Title
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB2450 + Anlotinib
Arm Type
Experimental
Arm Description
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).
Arm Title
Paclitaxel for injection (albumin bound)
Arm Type
Active Comparator
Arm Description
Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
TQB2450
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
a multi-target receptor tyrosine kinase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel for Injection (albumin bound)
Intervention Description
a anti-microtubule drug.
Primary Outcome Measure Information:
Title
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
Time Frame
up to 96 weeks
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Percentage of participants achieving complete response (CR) and partial response (PR).
Time Frame
up to 96 weeks
Title
Disease control rate（DCR）
Description
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 96 weeks
Title
Duration of Response (DOR)
Description
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time Frame
up to 96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
2. Severe hypersensitivity occurs after administration of other monoclonal antibodies.
3. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.
4. 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.
6. 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.
8. Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites.
10. 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.
13. Has received other anti-tumor therapy within 4 weeks before the first administration.
14. Has any serious and/or uncontrollable disease. 15. Has received vaccination or attenuated vaccine within 4 weeks before the first administration.
16. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghe Xu, Doctor
Phone
010-87788826
Email
xubinghe@medmail.com.cn
Facility Information:
Facility Name
The Fourth Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhong Xia, Doctor
Email
yhxia@sina.com
First Name & Middle Initial & Last Name & Degree
Yunhong Xia, Doctor
Facility Name
Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyan Ying, Doctor
Email
yinghy15@163.com
First Name & Middle Initial & Last Name & Degree
Hongyan Ying, Doctor
Facility Name
Beijing Shijitan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ren, Doctor
Email
jun.ren@duke.edu
First Name & Middle Initial & Last Name & Degree
Jun Ren, Doctor
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Luo, Doctor
Email
luobin@mail.tsinghua.edu.cn
First Name & Middle Initial & Last Name & Degree
Bin Luo, Doctor
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, Doctor
Phone
010-87788826
Email
xubinghe@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Binghe Xu, Doctor
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Zeng, Doctor
Email
1340110079@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaohua Zeng, Doctor
Facility Name
The First Affilited Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Gan, Doctor
Email
ganlu99@sina.com
First Name & Middle Initial & Last Name & Degree
Lu Gan, Doctor
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Liao, Doctor
Email
drningliao@163.com
First Name & Middle Initial & Last Name & Degree
Ning Liao, Doctor
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxian Zhou, Doctor
Email
939935994@qq.com
First Name & Middle Initial & Last Name & Degree
Wenxian Zhou, Doctor
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jincai Zhong, Master
First Name & Middle Initial & Last Name & Degree
Jincai Zhong, Master
Facility Name
The fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050010
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuizhi Geng, Doctor
Email
gengcuizhi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Cuizhi Geng, Doctor
Facility Name
Affiliated Tumor Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, Doctor
Email
sy86298276@163.com
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, Doctor
Facility Name
AnYang Tumor Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Sun
First Name & Middle Initial & Last Name & Degree
Jing Sun
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yahua Zhong, Doctor
Email
doctorzyh73@163.com
First Name & Middle Initial & Last Name & Degree
Yahua Zhong, Doctor
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quchang Ouyang, Doctor
Email
oyqc1969@126.com
First Name & Middle Initial & Last Name & Degree
Quchang Ouyang, Doctor
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojian Ge
Email
doctorge@126.com
First Name & Middle Initial & Last Name & Degree
Bojian Ge
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li, Doctor
Email
jdyylw@163.com
First Name & Middle Initial & Last Name & Degree
Wei Li, Doctor
Facility Name
Yanbian University Hospital
City
Yanji
State/Province
Jilin
ZIP/Postal Code
133000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songnan Zhang, Doctor
Email
zhangsn21@163.com
First Name & Middle Initial & Last Name & Degree
Songnan Zhang, Doctor
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuee Teng, Doctor
Phone
024-83282543
Email
tengyuee517@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yuee Teng, Doctor
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun, Doctor
Email
lnzlrxnsy@163.com
First Name & Middle Initial & Last Name & Degree
Tao Sun, Doctor
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuwen Wang, Doctor
Email
wangxiuwen@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Xiuwen Wang, Doctor
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuguo Tian, Master
Email
2205473988@qq.com
First Name & Middle Initial & Last Name & Degree
Fuguo Tian, Master
Facility Name
The Second Affiliated Hospital of PLA Airforce Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huadong Zhao, Doctor
Email
zhaolujy@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Huadong Zhao, Doctor
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Ren, Doctor
Email
renyyyyy@126.com
First Name & Middle Initial & Last Name & Degree
Yu Ren, Doctor
Facility Name
Shanxi Provincial People's Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710068
Country
China
Facility Name
The Second People's Hospital of Neijiang
City
Neijiang
State/Province
Sichuan
ZIP/Postal Code
641100
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xujuan Wang, Master
Email
61132803@qq.com
First Name & Middle Initial & Last Name & Degree
Xujuan Wang, Master
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
Facility Name
Xinjiang Uiger Municipal People's Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengcheng Su, Master
Email
drsupengcheng@163.com
First Name & Middle Initial & Last Name & Degree
Pengcheng Su, Master
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, Doctor
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, Doctor
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuming Qiu, Doctor
Email
qiufuming@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Fuming Qiu, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
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