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BCIRG 103
Study: BCIRG 103 (1839 IL / 0219)
| Title |
Presurgical study to evaluate molecular alterations that occur in human breast cancer tissue and normal skin after short term exposure to ZD1839 (Iressaâ) and to correlate these aleterations with pharmacokinetics parameters | ||
| Study Chairs |
Dennis Slamon, MD, John Forbes, MD, John Mackey, MD | ||
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Sponsor |
AstraZeneca Pharmaceuticals | ||
| Rationale |
The primary purpose of this trial is to evaluate the molecular effects of ZD1839 on breast cancer tissue not exposed to chemotherapy or radiation. Patients with untreated primary breast tumors amenable to a pre-treatment biopsy followed by definitive surgery represent an ideal population to study. The proposed tissue acquisition and correlative science trial is based on the following observations. First, the EGFR appears to play an important role in the pathogenesis and progression of a subset of human breast cancers. Therefore, EGFR inhibitors are of substantial clinical interest. The dose of ZD1839 selected (250mg/day), the proposed brief duration of treatment, and the fact that patients enrolled in this study will not be required to undergo any delay in definitve surgery shoulf ensure the safety of the trial | ||
| Design |
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Endpoints |
Primary: To identify the molecular alterations which occur in human breast tissue after short term exposure to ZD1839
Secondary: To evaluate the molecular effets of short term ZD1839 exposure in normal skin tissue and on EGFR signaling pathways in non-tumor cells (skin tissue). To correlate the pharmacokinetic parameters. To evaluate the toloerability and safety of short term exposure to a daily oral single dose of 250mg ZD1839 administration | ||
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Number of Patients Status
Study Communications |
50 patients
Completed
ASCO June 2004, New Orleans - Abstract 581
"Intratumoral and Plasma Concentrations of Gefitnib ('Iressa') in Breast Cancer Patients: Preliminary Results from a Presurgical Investigatory Study (BCIRG 103)" | ||
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