Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC

Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.

Trial Details

NCT ID
NCT06500208
Phase
PHASE2
Sponsor
Shanghai Jiao Tong University School of Medicine
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki6…
  • IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
  • At least one measurable lesion according to RECIST 1.1;
  • Available core needle biopsy samples for PD-L1 status testing;

For full eligibility, visit ClinicalTrials.gov.

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