Status:
COMPLETED
Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Metastasis
Eligibility:
FEMALE
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
- 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
- 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.
- Other primary lesions that are not of breast origin.
Key Trial Info
Start Date :
August 17 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01248897
Start Date
August 17 2010
End Date
September 5 2014
Last Update
June 19 2018
Active Locations (17)
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1
GSK Investigational Site
Hong Kong, Hong Kong
2
GSK Investigational Site
Pokfulam, Hong Kong
3
GSK Investigational Site
Tuenmen, Hong Kong
4
GSK Investigational Site
Wan Chai, Hong Kong