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.
Women aged 18-70 years old
Have finished radical operation
Histologically confirmed invasive ductal carcinoma (IDCA)
According to AJCC ,pT<8mm, pN0, no evidence for metastasis
pT≥8mm or node positive
Metastatic breast cancer
Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
Single group
Pyrotinib
Drug400mg po every day
Trastuzumab
DrugTrastuzumab 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.
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.
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.
Treatment-related adverse events
Incidence and severity of adverse events as assessed by NCI CTCAE V5.0
Change of LVEF after treatment
The change of LVEF after 3 months treatment compared to the baseline LVEF
Click on the lead sponsor to view all of their trials.
xuexin he
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
