Actively Recruiting
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
Led by Fudan University · Updated on 2024-12-13
129
Participants Needed
2
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
All trans retinoic acid Combined with Toripalimab+Chemotherapy for Locally Advanced inoperable or Metastatic Triple Negative Breast Cancer：a multi-center, multi-cohort phase II trial
CONDITIONS
Official Title
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age 18 years or older
- Locally advanced inoperable or metastatic breast cancer confirmed by histology with ER, PR, and Her-2 negative status
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Cohort 1: No prior treatment for locally advanced or metastatic TNBC; previous neoadjuvant/adjuvant therapy allowed if recurrence/metastasis occurred 12 months or more after treatment
- Cohort 2: Locally advanced or metastatic TNBC with at least one prior treatment failure
- Tumor biopsy or recent tumor samples available for biomarker analysis including PD-L1 levels
- Good organ function with blood counts and liver, kidney function within specified limits
- Expected survival of at least 3 months
- ECOG performance status score of 0-1
- Use of medically approved contraception during and for 6 months after study treatment for patients of childbearing potential, with negative pregnancy test before enrollment
You will not qualify if you...
- Previous treatment with PD-1 or PD-L1 monoclonal antibodies; prior albumin paclitaxel use for cohort 1
- Allergy to study drugs or hypersensitivity to vitamin A drugs
- Active autoimmune diseases requiring systemic treatment in past 2 years
- Immune deficiency or recent systemic steroid or immunosuppressive therapy
- Other malignant tumors requiring active treatment in past 5 years except certain cured local cancers
- Active central nervous system metastases
- History of non-infectious pneumonia requiring steroids
- Active infections needing systemic treatment
- Severe uncontrolled hypertension, diabetes, or hyperlipidemia
- Recent history of severe heart failure or heart attack
- HIV positive status
- Active hepatitis B or C infections
- Serious acute or chronic physical or mental health problems
- Use of prohibited medications within 7 days before enrollment
- Lactating women
- Participation in other anti-tumor drug trials within 4 weeks
- Conditions affecting medication intake or absorption
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhonghua Tao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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