OncoMatch/Clinical Trials/NCT05076682
Reverse Triple Negative Immune Resistant Breast Cancer
Is NCT05076682 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for triple-negative breast cancer.
Treatment: Choline · anti-PD-1 antibody and chemotherapy · Sodium Cromoglicate · Efavirenz · SHR-A1811 · SHR-A2102 · SHR-1316 · Mecapegfilgrastim · AK131 · Theophylline — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type (absence of HER2 expression)
absence of HER2, ER, and PR expression
Required: ESR1 wild-type (absence of ER expression)
absence of HER2, ER, and PR expression
Required: PR (PGR) wild-type (absence of PR expression)
absence of HER2, ER, and PR expression
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: immunotherapy — metastatic
evidence of recurrence or disease progression after immunotherapy (combined with targeted therapy or chemo ) for metastatic breast cancer
Cannot have received: chemotherapy
Exception: outpatient clinic surgery excluded
Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
Cannot have received: radiotherapy
Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
Cannot have received: immunotherapy
Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
Cannot have received: surgery
Exception: outpatient clinic surgery excluded
Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
Cannot have received: PEG-rhG-CSF in combination with immunotherapy
Exception: Mecapegfilgrastim group only
For the Mecapegfilgrastim group, patients had previously received PEG-rhG-CSF in combination with immunotherapy.
Lab requirements
Blood counts
Adequate hematologic function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
Kidney function
Adequate end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
Liver function
Adequate end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05076682 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiotherapy, immunotherapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify