Actively Recruiting
A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in 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
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations.
CONDITIONS
Official 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 trial protocol and sign informed consent
- Diagnosed with HER2-negative locally advanced or metastatic breast cancer by histopathology or cytology
- Previous chemotherapy for locally advanced or metastatic breast cancer was 3 lines or fewer
- Prior platinum therapy allowed 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
- Received antitumor therapy including Taxane with or without Anthracycline
- Front-line therapy failed due to progression or intolerance and suitable for systemic monotherapy
- Confirmed harmful or suspected harmful germline BRCA mutation by third-party central lab
- At least one measurable target lesion according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate bone marrow, liver, renal, and coagulation function as specified in protocol
- Women of childbearing potential willing to use effective contraception and negative pregnancy test before dosing
You will not qualify if you...
- Pregnant or lactating women
- Active inflammatory breast cancer
- Previous treatment with other PARP inhibitors including TSL-1502, Olaparib, Talazoparil, and others
- Known allergy to TSL-1502 or its components
- Active brain metastases or related symptoms requiring steroids
- Previous or current other malignancies
- Serious or uncontrolled clinical diseases including hepatic, renal, respiratory, endocrine, metabolic, neuropathy, mental disorders, or organ transplantation
- Gastrointestinal diseases affecting drug absorption
- Serious cardiovascular diseases or abnormalities within 6 months prior to dosing
- Participation in other drug or device trials within 4 weeks prior to dosing
- Major surgery or significant trauma within 4 weeks prior to dosing or planned during trial
- Recent chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other anti-tumor therapy within 4 weeks
- Unresolved adverse events from prior surgery or anti-tumor therapy above grade 1 except specified
- Use of CYP2D6 inhibitors or inducers within 2 weeks prior to dosing or unable to discontinue during trial
- Positive tests for treponema pallidum, HIV antibody, hepatitis C RNA, or active hepatitis B
- Other conditions judged by investigator to affect compliance or suitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
R
Rui Liu
CONTACT
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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