A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
HR-positive, HER2-negative Advanced Breast Cancer
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
Experimental
TQB3616 capsules combined with fulvestrant injection
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.