Actively Recruiting
All Trans Retinoic Acid Combined with Toripalimab Plus 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving All Trans Retinoic Acid together with Toripalimab plus chemotherapy for women with locally advanced inoperable or metastatic triple negative breast cancer (TNBC). This phase II trial aims to investigate this treatment approach across multiple centers and groups to better understand its impact on this aggressive form of breast cancer. Participants will be assigned to one of two treatment groups. Cohort 1 will receive Toripalimab intravenously every 21 days along with albumin paclitaxel on days 1 and 8, plus oral All Trans Retinoic Acid taken twice daily from day 3 to day 11 during each 21-day treatment cycle. Cohort 2 will receive Toripalimab intravenously every 21 days plus a chemotherapy regimen that may include monoclonal antibodies, elibulin, utideron, gemcitabine, albumin paclitaxel, or capecitabine, alongside oral All Trans Retinoic Acid following the same dosing schedule. Treatment courses last 21 days and may continue based on patient response and tolerability. During the study, participants will undergo biopsies or provide tumor samples for biomarker analysis, including PD-L1 expression. Researchers will monitor tumor response, overall survival, progression-free survival, duration of response, and adverse events including skin reactions for up to two years. Participants will have regular assessments to evaluate treatment effects and safety. The study began in November 2024 and is planned to continue until September 2029.
CONDITIONS
Brief 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...
- Voluntarily agree to participate and sign informed consent
- Female aged 18 years or older
- Confirmed locally advanced inoperable or metastatic triple negative breast cancer by histology/pathology
- Negative results for ER, PR, and Her-2 according to specific testing criteria
- At least one measurable lesion per RECIST 1.1 criteria
- Cohort 1: No prior treatment for locally advanced or metastatic TNBC except neoadjuvant/adjuvant therapy ended at least 12 months before recurrence
- Cohort 2: Previous treatment failure of one or more lines for local late stage inoperable or metastatic TNBC
- Ability to provide tumor tissue or samples for biomarker analysis
- Good organ function within 14 days before treatment as defined by blood counts and liver/kidney tests
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Use of medically approved contraception during and for 6 months after treatment for patients of childbearing potential
- Negative serum HCG test within 72 hours before enrollment for women of childbearing age without surgical sterilization
You will not qualify if you...
- Prior treatment with PD-1 or PD-L1 antibodies or albumin paclitaxel for cohort 1
- Allergy to any study drug
- Hypersensitivity to vitamin A drugs
- Active autoimmune disease requiring systemic treatment in past 2 years
- Immune deficiency or systemic steroid/immunosuppressive therapy within 7 days before enrollment
- Other malignant tumors progressing or requiring treatment in past 5 years (except certain cured local cancers)
- Active central nervous system metastases
- History of non-infectious pneumonia needing steroids
- Active infections requiring systemic treatment
- Uncontrolled serious hypertension, diabetes, or hyperlipidemia
- Recent heart failure or heart attack within 6 months
- Positive HIV test at screening
- Active hepatitis B or C infection
- Serious acute or chronic physical or mental illnesses
- Use of prohibited medications unless stopped 7 days prior
- Lactating women
- Participation in other anti-tumor drug trials within 4 weeks
- Conditions affecting ability to swallow or absorb medication
- Any other condition deemed unsuitable by researchers
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 - Repeated 21-day courses as per protocol
Participants receive combined treatment with all trans retinoic acid, Toripalimab, and chemotherapy drugs in repeating 21-day courses.
Multiple visits every 21 days corresponding to each treatment course
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
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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