Clinical trial NCT00633750
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2002-08-01; Completion date: 2007-10-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL)-positive tumor cells in patients with treatment-naive, operable breast cancer.

Secondary

* To identify a molecular profile, based on measurements of Estrogen Receptor (ER), Epidermal Growth Factor Receptor (EGFR), and a Human Epithelial Growth Factor Receptor-2(HER2), and protein expression profiles in patients with treatment-naïve, operable breast cancer that is responsive to erlotinib hydrochloride.
* To correlate tumor concentrations of erlotinib hydrochloride with serum levels immediately before surgery.

OUTLINE: This is a multi-center study.

Patients receive oral erlotinib hydrochloride once daily for 5-14 days. Patients then undergo surgical resection within 24 hours after the last dose of erlotinib hydrochloride.

Tumor tissue samples are collected at baseline and during surgery for correlative laboratory studies. Tissue samples are stained for ER, HER2, and EGFR levels, proliferation (Ki67), and apoptosis (TUNEL) by immunohistochemistry. Levels of erlotinib hydrochloride in tissue samples are measured by matrix-assisted laser desorption/ionization mass spectrometry. Blood samples are collected on the day of surgery. Levels of erlotinib hydrochloride in blood samples are measured by liquid chromatography/mass spectrometry.

Patients are followed within 6 weeks after surgery.

Arms: arm 1: None
Interventions: intervention 1: erlotinib hydrochloride intervention 2: TUNEL assay intervention 3: protein expression analysis intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis intervention 6: liquid chromatography intervention 7: mass spectrometry intervention 8: matrix-assisted laser desorption ionization mass spectrometry intervention 9: therapeutic conventional surgery
Intervention descriptions: intervention 1: 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. intervention 2: Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens intervention 3: Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens intervention 4: Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens intervention 5: Used to assess level of expression of genetic markers in pre-therapy and surgical specimens intervention 6: Used to determine blood plasma levels of Erlotinib on the day of surgery intervention 7: Used to determine blood plasma levels of Erlotinib on the day of surgery intervention 8: After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue intervention 9: Surgical treatment will occur within 24-hours following completion of therapy.

Protocol documents: