Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer

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, y

Trial Details

NCT ID
NCT07401537
Phase
PHASE2
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Extended-Dose Interval Immunotherapy
  • Standard-Dose Interval Immunotherapy
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Voluntary consent to participate in this study and signing of the informed consent form.
  • The age of the signatory of the informed consent form should be ≥18 years old and ≤70 years old.
  • Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative.
  • PD-L1 IHC detection in tumor tissue with a CPS score ≥1.

For full eligibility, visit ClinicalTrials.gov.

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