Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Trial Details

NCT ID
NCT07528716
Phase
PHASE3
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • SHR- A1811
  • PCbHP
  • SHR- A1811+ Pyrotinib
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Female patients aged 18 to 75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Histologically confirmed unilateral primary invasive breast cancer, staged as at least cT2 or cN1 (i.e., AJCC 8th edition stage II-III), and M0.
  • Pathologically confirmed HER2-positive breast cancer, defined as HER2 IHC 3+, or IHC 2+ with positive in situ hybridization (ISH).

For full eligibility, visit ClinicalTrials.gov.

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