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

This study is currently recruiting participants. (see Contacts and Locations)
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

November 24, 2010
October 4, 2013
August 2010
December 2013   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: Time from study entry to disease progression or death from any cause, in weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01248897 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Tumor tissues

Probability Sample

Asia Pacific erb2+/HER2 Breast Cancer Patients

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
April 2014
December 2013   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Hong Kong,   Korea, Republic of,   Malaysia,   Singapore
 
NCT01248897
114021
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP