Actively Recruiting
Reverse Triple Negative Immune Resistant Breast Cancer
Led by Fudan University · Updated on 2025-12-03
80
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, open-label, seven-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, theophylline) with immune checkpoint inhibitor or immune checkpoint inhibitor rechallenge(AK131) in mTNBC (triple negative breast cancer) patients who progressed during previous immune checkpoint inhibitors.
CONDITIONS
Official Title
Reverse Triple 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 triple-negative breast cancer (lacking HER2, ER, and PR expression)
- Evidence of recurrence or disease progression after immunotherapy combined with targeted therapy or chemotherapy for metastatic breast cancer
- Adequate blood counts and organ function based on lab tests within 14 days before starting study treatment
- Women of childbearing potential must agree to abstain from heterosexual intercourse or use contraception as specified
- Measurable disease according to 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 cardiovascular disease
- History of other cancers within 5 years except those with very low risk of metastasis or death
- Treatment with chemotherapy, radiotherapy, immunotherapy, or surgery (except outpatient surgery) within 3 weeks before starting study treatment
- Pregnancy, breastfeeding, or plans to become pregnant during the study
- Allergies to any drug components used in this trial
- History of eosinophilosis or mastocytosis
- Long-term oral steroid hormone use or recent occasional use without a 4-week stop period
- Prior use of PEG-rhG-CSF combined with immunotherapy for participants in the mecapegfilgrastim treatment group
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, 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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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