The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study

Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.

Trial Details

NCT ID
NCT06770296
Phase
PHASE1
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Pyrotinib low dose group
  • Pyrotinib normal dose group
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • The subjects voluntarily joins the study and signs the informed consent;
  • Subject is an adult female or male ≥ 18 years old and ≤ 75 years old at the time of informed consent;
  • HER2-positive advanced breast cancer confirmed by pathology:HER2-positive was defined as \>10% of immunoreactive cells with an immunohistochemical …
  • Recurrent or metastatic breast cancer; Patients with local recurrence had to be confirmed by the investigator as not amenable to curative resection;

For full eligibility, visit ClinicalTrials.gov.

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