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

This study is currently recruiting participants.
Verified September 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01248897
First received: November 24, 2010
Last updated: October 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Neoplasms, Metastasis
Other: This study is non-interventional study, so this section is not applicable.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study of Biomarker Profiles in Asia Pacific erbB2+/HER2 Breast Cancer Patients Treated With Lapatinib and Other Anti-erbB2/HER2 Therapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Time from study entry to disease progression or death from any cause, in weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Percentage of patients post-study entry showing complete or partial response to lapatinib ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time from study entry until death due to any cause, in weeks ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissues


Estimated Enrollment: 350
Study Start Date: August 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Asia Pacific erb2+/HER2 Breast Cancer Patients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248897

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Hong Kong
GSK Investigational Site Recruiting
Hong Kong, Hong Kong
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Pokfulam, Hong Kong
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Tuen Mun, Hong Kong
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Wanchai, Hong Kong
Korea, Republic of
GSK Investigational Site Completed
Busan, Korea, Republic of, 602-739
GSK Investigational Site Completed
Busan, Korea, Republic of, 602-715
GSK Investigational Site Completed
Busan, Korea, Republic of, 602-030
GSK Investigational Site Completed
Gangwon-do, Korea, Republic of, 210-852
GSK Investigational Site Completed
Incheon, Korea, Republic of, 400-711
GSK Investigational Site Completed
Kyunggi-do, Korea, Republic of, 410-769
GSK Investigational Site Completed
Seoul, Korea, Republic of, 110-744
GSK Investigational Site Completed
Seoul, Korea, Republic of, 137-701
GSK Investigational Site Completed
Seoul, Korea, Republic of, 136-705
GSK Investigational Site Completed
Seoul, Korea, Republic of, 120-752
GSK Investigational Site Completed
songpa-gu, Seoul, Korea, Republic of, 138-736
Malaysia
GSK Investigational Site Not yet recruiting
Kuala Lumpur, Malaysia, 50450
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Kuala Lumpur, Malaysia, 56000
Singapore
GSK Investigational Site Recruiting
Singapore, Singapore, 169610
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01248897     History of Changes
Other Study ID Numbers: 114021
Study First Received: November 24, 2010
Last Updated: October 4, 2013
Health Authority: Malaysia: Ministry of Health
Singapore: Health Sciences Authority
Taiwan: Department of Health
Philippines: Bureau of Food and Drugs
Hong Kong: Department of Health
Korea: Korea Food & Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014