Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer

This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer. Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydroc

Trial Details

NCT ID
NCT07635342
Phase
PHASE2
Sponsor
Hebei Medical University Fourth Hospital
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Pyrotinib Maleate
  • Trastuzumab (H, 8mg/kg
  • pegylated liposomal doxorubicin hydrochloride
  • Cyclophosphamide
  • Paclitaxel for Injection Albumin Bound
Locations (sample)
  • Shijiazhuang, Hebei, China|38.04139,114.47861

Key Eligibility Criteria

  • Female patients aged 18 to 65 years.
  • Patients with previously untreated invasive breast cancer confirmed by pathological examination.
  • HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (IS…
  • Clinical stage T2N0-3M0 or any T/N1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.

For full eligibility, visit ClinicalTrials.gov.

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