Actively Recruiting
A Randomized, Open-label Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations
Led by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. · Updated on 2024-05-08
125
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of TSL-1502 capsules in women with HER2-negative locally advanced or metastatic breast cancer who have germline BRCA mutations. This phase II clinical trial aims to assess how well the treatment works in controlling the disease and improving survival, as well as to estimate safety and pharmacokinetic parameters. Breast cancer is a leading cause of cancer death among women worldwide, and current treatments have limited effectiveness for advanced cases. Participants will be randomly assigned to one of three groups: one receiving a low dose of TSL-1502 capsules (350 mg once daily), another receiving a high dose of TSL-1502 capsules (500 mg once daily), or a third group receiving chemotherapy chosen by the investigator. Treatment cycles last three weeks. The chemotherapy options include capecitabine tablets, vinorelbine tartrate injection, or eribulin mesylate injection. The study is open-label and will monitor patients over extended periods. During the study, participants will undergo radiological scans every six weeks to evaluate tumor response, disease control, duration of response, progression-free survival, and overall survival for up to 40 months. Safety assessments will be conducted from screening until the final visit. The study includes monitoring of physical condition using the ECOG scale and requires blood tests to assess organ function. Women of childbearing potential must use effective contraception during and for six months after treatment. The total study duration includes long-term follow-up to collect comprehensive data on treatment effects and safety.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years who agree to follow the clinical trial protocol and sign informed consent
- Diagnosed with HER2-negative locally advanced or metastatic breast cancer unable to receive radical therapy
- Prior chemotherapy for advanced breast cancer limited to 3 lines or fewer
- Prior platinum therapy with best response of CR, PR, or stable disease for at least 12 weeks
- Hormone receptor-positive patients must have failed or be unsuitable for endocrine therapy
- Previous treatment with Taxane and/or Anthracycline in neoadjuvant, adjuvant, or metastatic settings
- Failure of front-line therapy and deemed suitable for systemic monotherapy
- Confirmed germline BRCA mutation by central laboratory
- At least one measurable target lesion meeting RECIST criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate bone marrow, liver, renal, and coagulation function
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before dosing
You will not qualify if you...
- Pregnant or breastfeeding women
- Active inflammatory breast cancer
- Previous treatment with PARP inhibitors including TSL-1502 or others
- Known allergy to TSL-1502 or its components
- Active brain metastases or recent brain metastasis treatment under 4 weeks
- History or current diagnosis of other malignancies
- Serious or uncontrolled clinical diseases such as organ dysfunction or mental disorders
- Gastrointestinal diseases affecting drug absorption
- Serious cardiovascular disease or recent cardiac events
- Participation in other clinical trials within 4 weeks prior to study
- Recent major surgery or trauma within 4 weeks
- Recent anti-tumor therapies within 4 weeks prior to study
- Unresolved adverse events from prior treatments above grade 1
- Use of CYP2D6 inhibitors or inducers within 2 weeks prior to dosing or inability to discontinue
- Positive for infectious diseases including syphilis, HIV, hepatitis C, or active hepatitis B
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 months or until disease progression or discontinuation
Participants receive assigned study treatments, including low dose or high dose TSL-1502 capsules or investigator's choice of chemotherapy, administered in repeated 3-week cycles.
Visits every 3 weeks for treatment and every 6 weeks for radiological scans
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
R
Rui Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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