Real World Study of Lapatinib Among Metastatic Breast Cancer Patients

February 23, 2024 updated by: Biyun Wang, MD, Fudan University

Real World Study of Lapatinib Among Metastatic Breast Cancer Patients in Clinical Practice: a Multicenter, Retrospective Study

A multicenter, retrospective, real world study of Lapatinib among Metastatic Breast Cancer (MBC) Patients in Clinical Practice.

Study Overview

Status

Completed

Conditions

Detailed Description

This study collected patients used Lapatinib-base therapy among MBC, and tried to figure out if there was difference between single anti-Her2 treatment and dual anti-Her2 treatment. Furthermore, this study investigated the treatment after Lapatinib.

Study Type

Observational

Enrollment (Actual)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Description

Inclusion Criteria:

  • Patients who were treated with Lapatinib between June 2014 to June 2018.
  • Patients experienced progression on prior trastuzumab-containing regimens and a taxane.
  • Complete medical history was available.

Exclusion Criteria:

  • Medical history was incomplete.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Continuing Lapatinib
Patients continued using treatment containing Lapatinib after progression on Lapatinib.
Change HER-2 treatment
Patients changed to another HER-2 targeted treatment after progression on Lapatinib (ado-trastuzumab emtansine, trastuzumab, etc.).
Lapatinib plus capetabine
Patients used lapatinib plus capetabine.
Lapatinib plus Trastuzumab and one chemotherapy
Patients used lapatinib plus trastuzumab and one chemo regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
Progression free survival
6 weeks
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Biyun Wang, Professor, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

May 20, 2020

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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