HR-positive, HER2-negative Advanced Breast Cancer
Conditions
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.
Interventions
DRUGTQB3616 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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Duration of Response (DOR) | Baseline up to 24 months | The time when the participants first achieved complete or partial remission to disease progression. |
Countries
China
Outcome results
None listed