Overview
This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.
Description
Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.
Eligibility
Inclusion Criteria:
- Women aged 18-75 years old
- HER2 positive breast cancer
- ECOG PS 0-1
- Known hormone receptor status
- Completed 1 year of trastuzumab-based adjuvant therapy within 6 months
- Patients at high risk
Exclusion Criteria:
- Serious heart disease or discomfort
- Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption
- Known allergic history of drug components of this regimen
- A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
- Pregnant and lactating female patients