At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer
In Brief
A Phase 2 clinical trial evaluating erlotinib hydrochloride, TUNEL assay, and 7 other interventions for Breast Cancer. Completed, enrolled 50 participants across 5 sites.
Detailed Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.
Study Details
Timeline
Interventions
Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
Used to determine blood plasma levels of Erlotinib on the day of surgery
Used to determine blood plasma levels of Erlotinib on the day of surgery
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
Surgical treatment will occur within 24-hours following completion of therapy.