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

Study Overview
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Brief Summary
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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.

Official Title
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A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer

Conditions
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HR-positive, HER2-negative Advanced Breast Cancer

Intervention / Treatment
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* Drug: TQB3616 capsules
* Drug: Fulvestrant injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQB3616 capsules combined with fulvestrant injection<br>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. | Drug: TQB3616 capsules<br>* TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.<br>Drug: Fulvestrant injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause. | Baseline up to 24 months | 
| 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. | Baseline up to 24 months] | 
| Clinical benefit rate (CBR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | Baseline up to 24 months | 
| Duration of Response (DOR) | The time when the participants first achieved complete or partial remission to disease progression. | Baseline up to 24 months |