Back to resultsA Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
Primary Purpose
HR-positive, HER2-negative Advanced Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQB3616 capsules
Fulvestrant injection
Sponsored by
About this trial
This is an interventional treatment trial for HR-positive, HER2-negative Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 3. 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.
Exclusion Criteria:
1. 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; 2. 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.
3. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.
4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Sites / Locations
- The Fifth Medical Center of PLA General HospitalRecruiting
- Chongqing University Cancer Hospital
- Gansu Provincial Hostipal
- Guangdong General Hospital
- Sun Yat-sen University Cancer Center
- Guangxi Medical University Affiliated Tumor Hospital
- The Fourth Hospital of Hebei Medical University
- Harbin Medical University Affiliated Cancer Hospital
- Hunan Cancer Hospital
- Jiangsu Province HospitalRecruiting
- The Second Hospital of Dalian Medical University
- Liaoning Cancer Hospital & Institute
- Shanghai East Hospital
- The Second Affiliated Hospital of PLA Air Force Military Medical University
- The First Affiliated Hospital of Xi'an Jiao Tong University
- Affiliated Tumor Hospital of Xinjiang Medical University
- The First Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQB3616 capsules combined with fulvestrant injection
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall response rate (ORR) assessed by investigator
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.
Secondary Outcome Measures
Progression free survival (PFS)
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Overall survival (OS)
OS defined as the time from first dose to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Clinical benefit rate (CBR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Full Information
NCT ID
NCT04796623
First Posted
March 11, 2021
Last Updated
March 11, 2021
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04796623
Brief Title
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
Official Title
A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HR-positive, HER2-negative Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB3616 capsules combined with fulvestrant injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TQB3616 capsules
Intervention Description
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by investigator
Description
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.
Time Frame
Baseline up to 24 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Time Frame
Baseline up to 24 months
Title
Overall survival (OS)
Description
OS defined as the time from first dose to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time Frame
Baseline up to 24 months]
Title
Clinical benefit rate (CBR)
Description
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
Baseline up to 24 months
Title
Duration of Response (DOR)
Description
The time when the participants first achieved complete or partial remission to disease progression.
Time Frame
Baseline up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 3. 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.
Exclusion Criteria:
1. 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; 2. 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.
3. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.
4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Facility Information:
Facility Name
The Fifth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zefei Jiang, Doctor
Phone
010-66947171
Email
jiangzefei@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Zefei Jiang, Doctor
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Not yet recruiting
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
Gansu Provincial Hostipal
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyun Huang, Doctor
Email
huangsam68@hotmail.com
First Name & Middle Initial & Last Name & Degree
Haiyun Huang, Doctor
First Name & Middle Initial & Last Name & Degree
Jie Hao, Doctor
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510062
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Wang, Doctor
Email
gzwangkun@126.com
First Name & Middle Initial & Last Name & Degree
Kun Wang, Doctor
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510062
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, Doctor
Email
shiyx@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, Doctor
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Xie, Doctor
Email
dd.xie@qq.com
First Name & Middle Initial & Last Name & Degree
Weimin Xie, Doctor
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunjiang Liu, Doctor
Email
lyj818326@126.com
First Name & Middle Initial & Last Name & Degree
Yunjiang Liu, Doctor
Facility Name
Harbin Medical University Affiliated Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
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
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quzhang Ouyang, Doctor
Email
oyqc_susar@126.com
First Name & Middle Initial & Last Name & Degree
Quzhang Ouyang, Doctor
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhai Tang, Doctor
Phone
025-68305758
Email
tangjinhai@jsph.org.cn
First Name & Middle Initial & Last Name & Degree
Jinhai Tang, Doctor
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116027
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Li, Doctor
Email
dyeyliman@sohu.com
First Name & Middle Initial & Last Name & Degree
Man Li, Doctor
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Not yet recruiting
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
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Li, Doctor
Email
liqun@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Qun Li, Doctor
Facility Name
The Second Affiliated Hospital of PLA Air Force Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haichuan Su, Doctor
Email
cntdgcp@163.com
First Name & Middle Initial & Last Name & Degree
Haichuan Su, Doctor
Facility Name
The First Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Ren, Doctor
Email
renyyyyyy@126.com
First Name & Middle Initial & Last Name & Degree
Yu Ren, Doctor
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Zhao, Doctor
Email
819502412@qq.com
First Name & Middle Initial & Last Name & Degree
Bing Zhao, Doctor
Facility Name
The First Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Shen
Email
zyyx_sp@163.com
First Name & Middle Initial & Last Name & Degree
Peng Shen
12. IPD Sharing Statement
Learn more about this trial
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
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