A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Trial Details

NCT ID
NCT05635487
Phase
PHASE2
Sponsor
Shengjing Hospital
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • SHR-A1811
  • Pyrotinib
Locations (sample)
  • Shenyang, Liaoning, China|41.79222,123.43278

Key Eligibility Criteria

  • Female patients aged ≥ 18 but ≤ 75 years
  • Histologically confirmed to be HER2-positive invasive breast cancer
  • Treatment-naive patients with stage II-III
  • Eastern Cooperative Oncology Group (ECOG) score 0-1

For full eligibility, visit ClinicalTrials.gov.

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