A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 120
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Fulvestrant

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:

1. Has other malignant tumors within 3 years;

2. Has multiple factors affecting oral medication;

3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;

4. Has active or uncontrolled severe infections before the first dose;

5. Cirrhosis, active hepatitis；

6. Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:

1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;

2. 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;

3. 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.