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funding terminated
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Indiana University | OTHER |
| Emory University | OTHER |
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This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.
OUTLINE: This is a multi-center study.
Sample Collection:
Treatment Regimen:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor and Serum Collection | Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Sample | Procedure | Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate serum and tumor proteomic profiles with response to lonafarnib | 24 months | |
| To compare serum and tissue proteomic analyses | 24 months | |
| To compare genomic and proteomic profiles |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.
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| Name | Affiliation | Role |
|---|---|---|
| George Sledge, M.D. | Hoosier Cancer Research Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| Label | URL |
|---|---|
| Hoosier Oncology Group Homepage | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.
| Serum Sample | Procedure | Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib. |
|
| 24 months |
| To correlate toxicity and /or response with drug-specific pharmacogenomic parameters | 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |