Actively Recruiting
Reverse HER2-negative Immune Resistant Breast Cancer
Led by Fudan University · Updated on 2025-11-17
10
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, open-label study evaluating the efficacy and safety of combined treatment (retinoic acid) with immune checkpoint inhibitor in HER2-negative breast cancer patients who progressed during previous immune checkpoint inhibitors.
CONDITIONS
Official Title
Reverse HER2-negative Immune Resistant Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG Performance Status of 0, 1, or 2
- Metastatic or locally advanced, histologically confirmed luminal breast cancer (ER >1%, PR >1%, HER2 negative) or triple negative breast cancer (ER <1%, PR <1%, HER2 negative)
- Evidence of disease recurrence or progression after immunotherapy for metastatic breast cancer
- Adequate blood and organ function based on lab tests within 14 days before treatment
- For women who can become pregnant: agree to abstain or use contraception as specified
- Measurable disease based on RECIST v1.1 criteria
- Ability to understand the study and willingness to participate and follow up
You will not qualify if you...
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Active or past autoimmune disease or immune deficiency
- Significant heart disease
- History of other cancers within 5 years except low-risk types
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery within 3 weeks before starting study treatment (excluding minor outpatient surgery)
- Pregnancy, breastfeeding, or intention to become pregnant during the study
- Allergy to any study drug components
- History of eosinophilosis or mastocytosis
- Long-term oral steroid use; if occasional past use, must stop steroids for 4 weeks before treatment
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
Z
Zhimin Shao, Professor
CONTACT
Z
Zhonghua Wang, Professor
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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