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This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lapatinib receivers | Experimental | Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib | Drug | GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples. | biomarker analysis of tumor biopsies pre/post dose | subjects on study up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors. | safety assessments of labs, hematology labs, Electrocardiogram, vital signs | subjects on study up to 15 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33136-1002 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26571496 | Derived | Spector NL, Robertson FC, Bacus S, Blackwell K, Smith DA, Glenn K, Cartee L, Harris J, Kimbrough CL, Gittelman M, Avisar E, Beitsch P, Koch KM. Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor. PLoS One. 2015 Nov 16;10(11):e0142845. doi: 10.1371/journal.pone.0142845. eCollection 2015. |
| Label | URL |
|---|---|
| Results for study EGF10027 can be found on the GSK Clinical Study Register. | View source |
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| Durham |
| North Carolina |
| 27710 |
| United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Dallas | Texas | 75235 | United States |
| GSK Investigational Site | Roanoke | Virginia | 24018 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| GSK Investigational Site | Ramat Gan | 52621 | Israel |
| GSK Investigational Site | Zrifin | 70300 | Israel |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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