Breast Cancer Clinical Trial
Official title:
EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth. It is not yet known whether surgery is more effective with or without
gefitinib in treating ductal carcinoma in situ.
PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery
works compared to surgery alone for the treatment of women with ductal carcinoma in situ of
the breast.
OBJECTIVES:
Primary
- Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue
samples of women with ductal carcinoma in situ (DCIS) of the breast treated with
gefitinib vs placebo followed by local surgery.
- Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs
EGFR-negative patients.
Secondary
- Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs
ER-negative and in HER2-positive vs HER2-negative patients with DCIS.
- Correlate levels of HER2 extracellular domain with biomarker modulation in patients
treated with these regimens.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive oral gefitinib once daily for 7-14 days or until the day before
local surgery. Patients then undergo lumpectomy or mastectomy.
- Arm II: Patients receive oral placebo once daily for 7-14 days or until the day before
local surgery. Patients then undergo local surgery as in arm I.
PROJECTED ACCRUAL: A total of 78 patients (39 per treatment arm) will be accrued for this
study within 1.5 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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