This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors \<8mm, node-negative, HER2-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
400mg po every day
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days
Disease-free Survival
stimated percentage of patients alive and disease-free at 5 years from randomization or censored at date of last follow-up.
Time frame: 5 years
Breast Cancer Specific Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.
Time frame: 5 years
Overall Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Time frame: 5 years
Treatment-related adverse events
Incidence and severity of adverse events as assessed by NCI CTCAE V5.0
Time frame: up to 3 months
Change of LVEF after treatment
The change of LVEF after 3 months treatment compared to the baseline LVEF
Time frame: up to 3 months
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