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This clinical trial will assess whether BMS-275291 can be administered safely in combination with standard adjuvant therapy for early breast cancer and whether plasma concentrations at trough exceed a target minimum.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-275291 | Drug |
Inclusion Criteria:
Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which has been completely resected.
Systemic therapy is planned according to one of the following three regimens:
ECOG performance status 0 or 1.
Adequate organ function as evidenced by:
Patients to receive adriamycin must have LVEF > 50% or acceptable function per the institutional practice as assessed by MUGA.
Signed informed consent.
Women age =/> 18 years
Patients must have recovered from reversible adverse events of prior surgery and any radiation therapy.
Women of childbearing potential must have a serum or urine pregnancy test within 72 hours prior to the start of study medication.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Chicago | Illinois | United States | |||
| Local Institution |
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| Indianapolis |
| Indiana |
| United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | The Bronx | New York | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Burlington | Vermont | United States |
| Local Institution | Vancouver | Washington | United States |
| Local Institution | Green Bay | Wisconsin | 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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| ID | Term |
|---|---|
| C422302 | N-((2S)-2-mercapto-1-oxo-4-(3,4,4- trimethyl-2,5-dioxo-1-imidazolidinyl)butyl)-L-leucyl-N,3- dimethyl-L-Valinamide |
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