A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
- Conditions
- HR-positive, HER2-negative Advanced Breast Cancer
- Interventions
- Drug: TQB3616 capsules
- Registration Number
- NCT04796623
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- 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.
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Concomitant disease and medical history:
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Has other malignant tumors within 3 years;
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Has multiple factors affecting oral medication;
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Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
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Has active or uncontrolled severe infections before the first dose;
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Cirrhosis, active hepatitis#
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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;
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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;
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Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
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Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3616 capsules combined with fulvestrant injection 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. TQB3616 capsules combined with fulvestrant injection TQB3616 capsules 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.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) assessed by investigator Baseline up to 24 months 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.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) Baseline up to 24 months PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Duration of Response (DOR) Baseline up to 24 months The time when the participants first achieved complete or partial remission to disease progression.
Overall survival (OS) Baseline up to 24 months] 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.
Clinical benefit rate (CBR) Baseline up to 24 months Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Trial Locations
- Locations (17)
The Fifth Medical Center of PLA General Hospital
🇨🇳Beijing, Beijing, China
Gansu Provincial Hostipal
🇨🇳Lanzhou, Gansu, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Harbin Medical University Affiliated Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shanxi, China
Affiliated Tumor Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China