Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC

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

Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

To explore the real world situation of trastuzumab and lapatinib combined chemotherapy in China, and to explore the relationship between progression free survival and treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

285

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
        • Biyun Wang, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 1. woman, age > 18 years old 2. Diagnosed with HER2 +Metastatic Breast Cancer 3. Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. Available medical history

Exclusion Criteria:

  • 1. Incomplete medical history

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
Dual anti-HER2 group
Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
Progression free survival
6 weeks
ORR
Time Frame: 6 weeks
Objective Response Rate
6 weeks
OS
Time Frame: 6 weeks
Overall survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Pattern
Time Frame: 6 weeks
Choice of Treatment
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2015

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

August 15, 2020

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-8

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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