Reversing immune resistance in triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, open‑label, three‑arm parallel study enrolls people with metastatic or locally advanced triple‑negative breast cancer who progressed during or after prior immune checkpoint inhibitor therapy. Participants receive combinations of repurposed and investigational agents (including choline, sodium cromoglicate, efavirenz, SHR‑A1811, SHR‑2102, mecapegfilgrastim and theophylline) alongside an anti‑PD‑1 antibody or an anti‑PD‑1 rechallenge (AK131) to modulate the tumor immune microenvironment. The main goals are to test safety and tumor response using RECIST v1.1 measurable disease criteria, with regular imaging and laboratory monitoring and predefined safety rules. The design is based on preclinical data showing these agents can enhance PD‑1 efficacy in mouse models and on promising subgroup responses from prior clinical work in the IM subtype of TNBC, and it is conducted at Fudan University Shanghai Cancer Center.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Zhimin Shao, Professor — Fudan U
• Study coordinator: Zhimin Shao, Professor
• Email: zhimingshao@yahoo.com
• Phone: 08664175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.