This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Pyrotinib 400mg qd po continuously
For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks
Taxanes: Usual clinical dose is administered, in a 21-day cycle.
Capecitabine: 650mg/m2 each time, given twice daily
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGPFS
the period of time from the start of treatment for cancer patients to the observation of disease progression, or death due to any reason
Time frame: 24months
CNS-PFS
the period of time from the start of treatment for cancer patients to the observation of intracranial progression , or death due to any reason
Time frame: 24months
ORR
the proportion of patients who have a partial or complete response to therapy
Time frame: 24months
DCR
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
Time frame: 24months
OS
the period of time from the start of treatment for cancer patients to the observation of death due to any reason
Time frame: 24months
Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events
Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of the same AE in one participant.
Time frame: 24months
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