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Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

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Fudan University

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04850625
YOUNGBC-14

Details and patient eligibility

About

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Full description

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib plus Vinorelbine versus Lapatinib plus Capecitabine in patients with previously treated HER2-positive metastatic breast cancer.

Enrollment

224 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 were previously treated with trastuzumab in the advanced setting and a taxane in any setting.
  • Patients received lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2) or pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days) for at least one cycle, starting from Jun 2015 to Jan 2021.
  • Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

Exclusion criteria

  • Incomplete medical history

Trial design

224 participants in 2 patient groups

Pyrotinib Plus Vinorelbine
Description:
lapatinib (750-1,250 mg/day) plus capecitabine (1,500-2,000 mg/m2)
Lapatinib Plus Capecitabine
Description:
pyrotinib (320-400 mg/day) plus vinorelbine (25mg/ m2 intravenously or 60 mg/m2 orally on days 1 and 8 per 21 days)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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