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| ID | Type | Description | Link |
|---|---|---|---|
| TBCRC 015 | Other Identifier | Translational Breast Cancer Reseach Consortium |
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| Name | Class |
|---|---|
| Translational Breast Cancer Research Consortium | OTHER |
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).
Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Women with breast cancer receiving capecitabine as treatment for their breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Side-effect questionnaires | Other | Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Genetic variants of toxicity | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to toxicity based on genetics | 2 years | |
| Multiple genetic variants as predictors | 2 years | |
| Genome-wide association (potential) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.
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| Name | Affiliation | Role |
|---|---|---|
| Peter H O'Donnell, MD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Georgetown University |
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Blood (including DNA)
| research blood samples | Other | Blood samples for research on DNA before starting treatment and after 4 cycles of treatment |
|
| 2 years |
| Correlative sample collection | 2 years |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 73232 | United States |
| Baylor University | Houston | Texas | 77030 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| 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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