NCT03894410

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

March 27, 2019

Last Update Submit

February 23, 2024

Conditions

Breast Cancer

Keywords

HER2Lapatinib

Outcome Measures

Primary Outcomes (2)

  • PFS

    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)

    6 weeks

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Medical history was incomplete.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 28, 2019

Study Start

January 10, 2019

Primary Completion

November 15, 2019

Study Completion

May 20, 2020

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)