Actively Recruiting
A Phase II Study of Triple-negative Breast Cancer Brain Metastases.
Led by Fudan University · Updated on 2024-07-18
35
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.
CONDITIONS
Official Title
A Phase II Study of Triple-negative Breast Cancer Brain Metastases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- ECOG performance status between 0 and 2
- Pathologically confirmed HR-negative and HER2-negative breast cancer with local recurrence or metastasis
- No prior platinum drug use or prior use of only one platinum regimen with sensitivity confirmed
- MRI-confirmed brain metastases with at least one lesion of 1.0 cm or larger without prior radiotherapy
- Stable dose of mannitol or steroid hormone therapy for at least one week before enrollment
- Adequate major organ function including blood counts, coagulation, liver and kidney function, cardiac function, and ECG parameters
- Willingness to participate, provide informed consent, and comply with follow-up
You will not qualify if you...
- Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture
- Uncontrolled third interstitial fluid such as large pleural effusion or ascites
- Whole brain radiotherapy, chemotherapy, or surgery within 14 days before enrollment
- Prior targeted or endocrine therapy within the previous week
- Prior bevacizumab or PD-1/PD-L1 therapy for HR-/HER2- patients
- Participation in other clinical trials within 2 weeks before enrollment
- Concurrent use of other anti-cancer drugs
- Other malignancies within 5 years except certain cured skin or cervical cancers
- History of significant heart diseases or arrhythmias
- Allergy or hypersensitivity to study drugs or components
- History of immunodeficiency or organ transplantation
- Neurological or mental disorders including epilepsy or dementia
- Pregnant or breastfeeding women or unwillingness to use contraception
- Serious concomitant diseases affecting safety or study completion
- Any condition deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Zhang, MD
CONTACT
T
Ting Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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