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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erbB2+/Her2 Breast Cancer Patients | erbB2+/Her2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/Her2 Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This study is non-interventional study, so this section is not applicable. | Other | This study is non-interventional study, so this section is not applicable. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Time from study entry to disease progression or death from any cause, in weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Percentage of patients post-study entry showing complete or partial response to lapatinib | |
| Overall survival | Time from study entry until death due to any cause, in weeks | |
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Inclusion Criteria:
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:
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 Criteria:
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Asia Pacific erb2+/HER2 Breast Cancer Patients
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hong Kong | Hong Kong | ||||
| GSK Investigational Site |
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Tumor tissues
| Progression free survival |
| Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks |
| Pokfulam |
| Hong Kong |
| GSK Investigational Site | Tuenmen | Hong Kong |
| GSK Investigational Site | Wan Chai | Hong Kong |
| GSK Investigational Site | Pasay | 1300 | Philippines |
| GSK Investigational Site | Singapore | 169610 | Singapore |
| GSK Investigational Site | Busan | 602-030 | South Korea |
| GSK Investigational Site | Busan | 602-715 | South Korea |
| GSK Investigational Site | Busan | 602-739 | South Korea |
| GSK Investigational Site | Gangwon-do | 210-852 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Kyunggi-do | 410-769 | South Korea |
| GSK Investigational Site | Seoul | 110-744 | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 136-705 | South Korea |
| GSK Investigational Site | Seoul | 137-701 | South Korea |
| GSK Investigational Site | Songpa-gu, Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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