OncoMatch/Clinical Trials/NCT07401537
Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer
Is NCT07401537 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Extended-Dose Interval Immunotherapy and Standard-Dose Interval Immunotherapy for triple -negative breast cancer.
Treatment: Extended-Dose Interval Immunotherapy · Standard-Dose Interval Immunotherapy — Triple-negative breast cancer (TNBC), defined by the lack of ER, PR and HER2 expression, is refractory to endocrine therapy and anti-HER2 agents. Chemotherapy was once the mainstay for advanced TNBC, but its limited efficacy necessitates optimized therapeutic strategies. TNBC's high TIL infiltration and elevated PD-L1 expression confer sensitivity to immune checkpoint inhibitors (ICIs), with ICI-chemotherapy combinations initially establishing first-line standard status. Emerging clinical evidence shows that ICI-antibody-drug conjugate (ADC) combinations outperform ICI-chemotherapy regimens, yet immune-related adverse events (irAEs) remain a critical clinical challenge. Expert consensus recommends continuing ICI therapy in advanced TNBC patients achieving CR, PR or SD after ICI-based combination therapy until disease progression or intolerable toxicity. Mechanistically, once ICIs reach target receptor saturation, dose escalation or high-frequency administration fails to boost efficacy but raises toxicity risk. Thus the investigators hypothesize that an ICI maintenance strategy with fixed dose and extended intervals can preserve efficacy, reduce toxicity, improve patient compliance, enhance quality of life and alleviate economic burden for advanced TNBC patients with CR/PR/SD after ICI-chemotherapy or ICI-ADC treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative
ER-negative
Required: PR (PGR) negative
PR-negative
Required: HER2 (ERBB2) negative
HER2-negative
Required: PD-L1 (CD274) CPS score ≥1 (CPS score ≥1)
PD-L1 IHC detection in tumor tissue with a CPS score ≥1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immunotherapy combined with chemotherapy or immunotherapy combined with antibody-drug conjugate — first-line
Have received first-line standard immunotherapy combined with chemotherapy or immunotherapy combined with ADC and completed 6 cycles
Cannot have received: topoisomerase I inhibitor (irinotecan, topotecan)
Prior administration of irinotecan, topotecan, or any other topoisomerase I inhibitors (including investigational topoisomerase I inhibitors)
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Cardiac function
Presence of poorly controlled clinical cardiac symptoms or diseases, such as: 1) Heart failure of NYHA class II or above; 2) Unstable angina pectoris; 3) Myocardial infarction occurring within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention [excluded]
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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