NCT05076682RecruitingPhase 2
Reverse Triple Negative Immune Resistant Breast Cancer
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 12 Sept 2021
- Start date
- 30 Jun 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fudan University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05076682
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 30 Jun 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Symptomatic, untreated, or actively progressing CNS metastases
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.