This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
anti-HER2 tyrosine kinase inhibitor
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
RECRUITINGOverall response rate (ORR)
ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
Time frame: From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.
Time frame: From the date of starting pyrotinib to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
Adverse events
Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Time frame: From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year)
Yin
CONTACT
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