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OpenTrials
Completed

NCT Number: NCT04850625

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    Progression free survival

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine in Patients With Previously Treated HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2021
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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