Recruiting

Reverse Triple Negative Immune Resistant Breast Cancer

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.

ClinicalTrials.gov IDNCT05076682

PhasePHASE2

Enrollment80

SponsorFudan University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Triple-negative Breast Cancer

About this study

Interventions

Drug: Choline — Choline 300mg tid or 500mg bid, p.o
Drug: anti-PD-1 antibody and chemotherapy — PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Drug: Sodium Cromoglicate — Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)
Drug: Efavirenz — Efavirenz 600mg qd, p.o
Drug: SHR-A1811 — 4.8mg/kg q3w
Drug: SHR-A2102 — 6mg/kg q3w
Drug: SHR-1316 — 1200mg q3w
Drug: Mecapegfilgrastim — Mecapegfilgrastim, 6mg, d3, q3w, s.c.
Drug: AK131 — AK131, 40mg/kg i.v., q2w
Drug: Theophylline — Theophylline, 100mg bid, p.o.

Primary outcomes

Objective Response Rate (ORR) (Baseline until disease progression or loss of clinical benefit, assessed up to 6 months)
Immune changes in peripheral blood (Baseline until disease progression or loss of clinical benefit, assessed up to 6 months)

Eligibility information

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.

Study locations

Fudan University Shanghai Cancer Center, Shanghai, 200032 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.