Can a drug cocktail revive immunotherapy for breast cancer?
NCT ID NCT05076682
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing several drug combinations (including choline, sodium cromoglicate, efavirenz, and others) alongside immunotherapy to see if they can reverse resistance in triple-negative breast cancer that has progressed after prior immunotherapy. About 80 participants with metastatic or locally advanced disease will be enrolled. The goal is to find a safe and effective way to make tumors respond again to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination of drugs (choline, sodium cromoglicate, efavirenz, SHR-A1811, SHR-A2102, SHR-1316, mecapegfilgrastim, AK131, and others) plus an immune checkpoint inhibitor
- What this could lead to
- If it works, this could point toward a way to re-sensitize triple-negative breast cancer to immunotherapy, offering a new treatment option for patients who have stopped responding.
- What could go wrong
- This is an early phase 2 trial with only 80 participants and multiple drug combinations, so it is unclear which combination works best or if any will prove effective. Side effects from the drug cocktail may also be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2022
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Triple negative breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fudan University Shanghai Cancer Center
RECRUITINGShanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cholesterol drug simvastatin joins chemo in breast cancer trial
- Gut bacteria may hold clues to why some cancer treatments work better
- Unlocking TNBC survival: genetic clues from 3,648 women
- New drug targets Sugar-Coated proteins on cancer cells
- New antibody aims to preserve immune checkpoint while fighting cancer
- Blood test aims to track cancer treatment response in real time