Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib
NCT ID: NCT01248897
Last Updated: 2018-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
158 participants
OBSERVATIONAL
2010-08-17
2014-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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erbB2+/Her2 Breast Cancer Patients
erbB2+/Her2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/Her2 Therapy
This study is non-interventional study, so this section is not applicable.
This study is non-interventional study, so this section is not applicable.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
2. Other primary lesions that are not of breast origin.
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hong Kong, , Hong Kong
GSK Investigational Site
Pokfulam, , Hong Kong
GSK Investigational Site
Tuenmen, , Hong Kong
GSK Investigational Site
Wan Chai, , Hong Kong
GSK Investigational Site
Pasay, , Philippines
GSK Investigational Site
Singapore, , Singapore
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Gangwon-do, , South Korea
GSK Investigational Site
Incheon, , South Korea
GSK Investigational Site
Kyunggi-do, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Songpa-gu, Seoul, , South Korea
Countries
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Other Identifiers
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114021
Identifier Type: -
Identifier Source: org_study_id
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