A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer
1 other identifier
interventional
122
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Typical duration for phase_2
17 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
Study Start
First participant enrolled
February 4, 2021
CompletedFirst Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2024
CompletedApril 8, 2026
April 1, 2026
3.3 years
March 11, 2021
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to 24 months
Secondary Outcomes (4)
Progression free survival (PFS)
Baseline up to 24 months
Overall survival (OS)
Baseline up to 24 months]
Clinical benefit rate (CBR)
Baseline up to 24 months
Duration of Response (DOR)
Baseline up to 24 months
Study Arms (1)
TQB3616 capsules combined with fulvestrant injection
EXPERIMENTALTQB3616 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.
Interventions
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.
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. 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:
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- 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.
- \. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
Gansu Provincial Hostipal
Lanzhou, Gansu, 730030, China
Guangdong General Hospital
Guangzhou, Guangdong, 510062, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510062, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, 710038, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 15, 2021
Study Start
February 4, 2021
Primary Completion
May 24, 2024
Study Completion
May 24, 2024
Last Updated
April 8, 2026
Record last verified: 2026-04