Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib (BioPATH)

June 18, 2018 updated by: GlaxoSmithKline

A Study of Biomarker Profiles in Asia Pacific erbB2+/HER2 Breast Cancer Patients Treated With Lapatinib and Other Anti-erbB2/HER2 Therapy

The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

158

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • GSK Investigational Site
      • Pokfulam, Hong Kong
        • GSK Investigational Site
      • Tuen Mun, Hong Kong
        • GSK Investigational Site
      • Wanchai, Hong Kong
        • GSK Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • GSK Investigational Site
      • Busan, Korea, Republic of, 602-739
        • GSK Investigational Site
      • Busan, Korea, Republic of, 602-030
        • GSK Investigational Site
      • Gangwon-do, Korea, Republic of, 210-852
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • GSK Investigational Site
      • Kyunggi-do, Korea, Republic of, 410-769
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • GSK Investigational Site
      • Songpa-gu, Seoul, Korea, Republic of, 138-736
        • GSK Investigational Site
  • Philippines
      • Pasay City, Philippines, 1300
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 169610
        • GSK Investigational Site

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Asia Pacific erb2+/HER2 Breast Cancer Patients

Description

Inclusion Criteria:

  1. HER2-positive (defined as either (a) IHC3+ or (b) FISH+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. These are either new, current or completed cases from any of the following settings:

    • treated according to physician's clinical judgement in routine practice; or
    • treated in clinical trials with known allocation to lapatinib-based regimen; or
    • treated via lapatinib expanded access or named patient programs. These regimens should contain lapatinib as the only anti-HER2 agent.
  2. Exposed to < 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. These regimens should contain trastuzumab as the only anti-HER2 agent.
  3. Patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. If this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-HER2 therapy.
  4. Willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. If consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation.

Exclusion Criteria:

  1. Patients who have been exposed to other experimental anti-HER2 therapy eg. pertuzumab, trastuzumab-DM, neratinib, ertumaxomab, AV-412, BIBW2992, CUDC-101, anti-HER2 vaccines.
  2. Other primary lesions that are not of breast origin.

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
Intervention / Treatment
erbB2+/Her2 Breast Cancer Patients
erbB2+/Her2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/Her2 Therapy
Other: This study is non-interventional study, so this section is not applicable.
This study is non-interventional study, so this section is not applicable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: Time from study entry to disease progression or death from any cause, in weeks
Time from study entry to disease progression or death from any cause, in weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: Percentage of patients post-study entry showing complete or partial response to lapatinib
Percentage of patients post-study entry showing complete or partial response to lapatinib
Overall survival
Time Frame: Time from study entry until death due to any cause, in weeks
Time from study entry until death due to any cause, in weeks
Progression free survival
Time Frame: Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks
Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

August 17, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

September 5, 2014

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114021

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.

Clinical Trials on Neoplasms, Metastasis

Clinical Trials on This study is non-interventional study, so this section is not applicable.

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Conditions

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Locations

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