At a glance
ClinicalIndex Comparison Record- ✓ECOG Performance Status 0, 1, or 2
- ✓Metastatic or locally advanced, histologically documented TNBC (HER2, ER, PR negative)
- ✓Disease progression after prior immunotherapy (with targeted therapy or chemo) for metastatic breast cancer
- ✓Adequate hematologic and end-organ function with labs within 14 days of treatment start
- ✕Symptomatic, untreated, or actively progressing CNS metastases
- ✕Active or history of autoimmune disease or immune deficiency
- ✕Significant cardiovascular disease
- ✕History of malignancy other than breast cancer within 5 years, except those with negligible metastasis/death risk
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Reverse Triple Negative Immune Resistant Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Choline, anti-PD-1 antibody and chemotherapy, and 8 other interventions for Triple-negative Breast Cancer. Currently recruiting, targeting 80 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Choline 300mg tid or 500mg bid, p.o
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)
Efavirenz 600mg qd, p.o
4.8mg/kg q3w
6mg/kg q3w
1200mg q3w
Mecapegfilgrastim, 6mg, d3, q3w, s.c.
AK131, 40mg/kg i.v., q2w
Theophylline, 100mg bid, p.o.