Status:
UNKNOWN
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
HR-positive, HER2-negative Advanced Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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:
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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.
- 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.
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04796623
Start Date
February 4 2021
End Date
January 31 2023
Last Update
March 15 2021
Active Locations (17)
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1
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100039
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
3
Gansu Provincial Hostipal
Lanzhou, Gansu, China, 730030
4
Guangdong General Hospital
Guangzhou, Guangdong, China, 510062