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Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05572645
Enrollment
333
Registered
2022-10-10
Start date
2022-10-01
Completion date
2023-09-01
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Pyrotinib, Trastuzumab, Pertuzumab

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.

Interventions

DRUGPyrotinib Plus Trastuzumab

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

DRUGPertuzumab 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)

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PFS6 weeksProgression free survival

Secondary

MeasureTime frameDescription
Adverse Events6 weeksNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026