About this trial
This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);
Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
ECOG score 0-1;
Disqualifiers
Known allergic history of the drug components of this protocol;
Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
Stage IV (metastatic) breast cancer patients;
Trial population
HER2-positive early stage breast cancer patients
Trial design
Cohort
Prospective
Treatments tested in this trial
Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection
DrugGroup A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection
Treatment groups
Trial outcomes
Primary outcomes
EORTC QLQ-C30 scale score
PRO scale scores between two groups collected at different time points
Secondary outcomes
tpCR
total pathological complete response
Locations
Sponsors and contacts
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