Clinical trial · Interventional
Reverse Triple Negative Immune Resistant Breast Cancer
NCT05076682CI-TRIAL-00098261RenaissancerecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK131 | Drug | — | UNRESOLVED |
| anti-PD-1 antibody and chemotherapy | Drug | — | UNRESOLVED |
| Choline | Drug | — | UNRESOLVED |
| Efavirenz | Drug | — | UNRESOLVED |
| Mecapegfilgrastim | Drug | — | UNRESOLVED |
| SHR-1316 | Drug | Adebrelimab | ALIAS |
| SHR-A1811 | Drug | — | UNRESOLVED |
| SHR-A2102 | Drug | — | UNRESOLVED |
| Sodium Cromoglicate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Choline
- description
- Choline with anti-PD-1 immunotherapy
- interventionNames
- Drug: Choline
- Drug: anti-PD-1 antibody and chemotherapy
- type
- EXPERIMENTAL
- label
- Sodium cromoglicate
- description
- Sodium cromoglicate with anti-PD-1 immunotherapy
- interventionNames
- Drug: anti-PD-1 antibody and chemotherapy
- Drug: Sodium Cromoglicate
- type
- EXPERIMENTAL
- label
- Efavirenz
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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 prior to screening, with the exception of those with a negligible risk of metastasis or death * Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * History of allergies to the drug components of this trial * History of eosinophilosis or mastocytosis * 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.
References
Publications (1)
- DERIVEDWu SY, Jin X, Liu Y, Wang ZY, Zuo WJ, Ma D, Xiao Y, Fu T, Xiao YL, Chen L, Liu XY, Fan L, Wang ZH, Shen M, Liu R, Chai WJ, Shao ZM, Jiang YZ. Mobilizing antigen-presenting mast cells in anti-PD-1-refractory triple-negative breast cancer: a phase 2 trial. Nat Med. 2025 Jul;31(7):2405-2415. doi: 10.1038/s41591-025-03776-7. Epub 2025 Jun 25. PMID 40563015