Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05572645
- Lead Sponsor
- Fudan University
- Brief Summary
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab
- Detailed Description
This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 333
Inclusion Criteria
- HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
- Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.
- Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.
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Exclusion Criteria
- Incomplete medical history
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PertH Pertuzumab Plus Trastuzumab treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) PyroH Pyrotinib Plus Trastuzumab treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
- Primary Outcome Measures
Name Time Method PFS 6 weeks Progression free survival
- Secondary Outcome Measures
Name Time Method Adverse Events 6 weeks Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China