Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer
The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin combined with pyrotinib in previously untreated histologically proven HER2 positive early breast cancer and evaluate the PCR DFS,OS and safety of the subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Disitamb Vedotin combined with pyrotinib
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGpathologic complete response(pCR)
The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H\&E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation
Time frame: 1 year
Disease free survival (DFS)
The time from randomization until disease recurrence or death due to progression of the disease.
Time frame: 3 years
Overall Survival(OS)
It is defined as the time from the start of treatment to death for any reason.
Time frame: 5year
The Number of Participants Who Experienced Adverse Events (AE)
according to the CTCAE's grading criteria
Time frame: 1 year
Patient Report Outcome(PRO)
The report is directly obtained from the patient's self-report of their health status, functional status, and treatment experienceThe European O-rganization for Reasearch and Treatment of Cancer(QLQ-C30)、QLQ-BR32,EQ-5D-5L,PRO-CTCAE
Time frame: 3years
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