Tests combined treatments with immune checkpoint inhibitors in triple-negative breast cancer
Tests combined treatment in breast cancer patients whose disease worsened on earlier immunotherapy.
Plain-language title generated from the registry record
Registry title: Reverse Triple Negative Immune Resistant Breast Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05076682, who can take part
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fudan University
- Trial code
- NCT05076682
- Record updated
- 23 October 2026
- Original description
This is a Phase II, open-label, nine-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, theophylline, mifepristone) with immune checkpoint inhibitor or immune checkpoint inhibitor rechallenge(AK131) in mTNBC (triple negative breast cancer) patients who progressed during previous immune checkpoint inhibitors.Read full original descriptionShow less
Reverse Triple Negative Immune Resistant Breast Cancer
This is a Phase II, open-label, nine-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, theophylline, mifepristone) with immune checkpoint inhibitor or immune checkpoint inhibitor rechallenge(AK131) in mTNBC (triple negative breast cancer) patients who progressed during previous immune checkpoint inhibitors.
Inclusion: ECOG Performance Status of 0, 1, or 2; Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression); Radiologic/objective evidence of recurrence or disease progression after immunotherapy(combined with targeted therapy or chemo ) for metastatic breast cancer(MBC); Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment; For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm; Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); have the cognitive ability to understand the protocol and be willing to participate and to be followed up.
Exclusion: Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment; Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past; For the Mecapegfilgrastim group, patients had previously received PEG-rhG-CSF in combination with immunotherapy; Active or history of autoimmune disease or immune deficiency; Significant cardiovascular disease; History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death; History of allergies to the drug components of this trial; History of eosinophilosis or mastocytosis; Symptomatic, untreated, or actively progressing CNS metastases; Pregnancy or breastfeeding, or intention of becoming pregnant during the study.