Breast Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGPyrotinib
Patients receive pyrotinib 400mg/day for half or one year
Sponsors
Taizhou Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18-75 years old 2. HER2 positive breast cancer 3. ECOG PS 0-1 4. Known hormone receptor status 5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months 6. Patients at high risk
Exclusion criteria
1. Serious heart disease or discomfort 2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption 3. Known allergic history of drug components of this regimen 4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation 5. Pregnant and lactating female patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iDFS | From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months | INVASIVE DISEASE FREE SURVIVAL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of receiving drug until the date of death from any cause, assessed up to 60 months | Overall Survival |
| Adverse events | through study completion, an average of 5 years | frequency of adverse events |
Countries
China
Contacts
Primary ContactFeilin Cao, Master
Backup ContactZhiqiang Xiao, Master
Outcome results
None listed