ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer
- Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer
treated with gefitinib with or without tamoxifen.
- Determine the toxic effects of these regimens in these patients.
- Determine whether changes in fludeoxyglucose F 18 uptake by positron emission
tomography scan and changes in plasma DNA levels are indicators of an early response to
gefitinib in these patients.
- Determine the pharmacokinetics of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to population (intent-to-treat population comprising all patients who
receive 1 dose of treatment vs a subset of the intent-to-treat population, excluding
patients with nonmeasurable/evaluable only disease). Patients are randomized to 1 of 2
- Arm I: Patients receive oral tamoxifen once daily. Beginning 14 days after the start of
tamoxifen, patients receive oral gefitinib once daily.
- Arm II: Patients receive oral placebo once daily. Beginning 14 days after the start of
placebo, patients receive oral gefitinib as in arm I.
In both arms, treatment continues for 26 weeks in the absence of disease progression or
Patients are followed for 6 months.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this
study within 23 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks
Gary N. Schwartz, MD
Norris Cotton Cancer Center
United States: Food and Drug Administration
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|