A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Pyrotinib 400mg/day
Fei Ma
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival (PFS)
From date of first use Pyrotinib until the date of first documented progression or date of death from any cause, whichever came first
Time frame: up to 36 months
Adverse events (AEs)
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
Time frame: up to 36 months
Overall Response rates (ORR)
Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Time frame: up to 36 months
Clinical Benefit rate (CBR)
Defined as CR+PR+stable disease (SD), assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Time frame: up to 36 months
Time to Progression (TTP)
Time from first use Pyrotinib to disease progression
Time frame: up to 36 months
Quality of Life(QoL)
Using the EORTC quality of life questionnaire QLQ-C30
Time frame: up to 36 months
Overall survival (OS)
Time from first use Pyrotinib to death
Time frame: up to 52 months
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