Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects enrolled in this study must meet all of the following inclusion criteria: 1.Age >=18 years old; 2.Pathologically or histologically confirmed HER2-positive breast cancer patients; 3.Plan to receive neoadjuvant pyrotinib; 4.Voluntarily join the study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Excluded patients with one of the following conditions: 1.Major surgery unrelated to breast cancer within 4 weeks prior to randomization, or such surgery that has not fully recovered; 2.Pregnant or lactating female patients, female patients with a positive baseline pregnancy test, or fertile patients who are unwilling to take effective contraceptive measures throughout the trial period and within 7 months after the last dose; 3.Serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition in which the patient is considered unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Metastasis-Free Survival;Objective Response Rate;Overall survival;safety; | — |
Countries
China