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NCT05572645 Clinical Trial

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Breast Cancer Clinical Trial

Official title:
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05572645
Other study ID # YOUNGBC-21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date September 1, 2023

Study information
Verified date February 2024
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

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 information / eligibility
Status Completed
Enrollment 333
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: - Incomplete medical history

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pyrotinib Plus Trastuzumab
treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
• 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)

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Progression free survival 6 weeks
Secondary Adverse Events Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 6 weeks
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