Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen.
PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.
Drug: tamoxifen citrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer|
- Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||November 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Tamoxifen
Tamoxifen 20 mg po once daily
250 mg po once daily
Other Name: ZD1839, IressaDrug: tamoxifen citrate
20 mg po once daily
Other Name: Nolvadex
Placebo Comparator: Placebo
Placebo comparator one tablet po once daily
250 mg po once daily
Other Name: ZD1839, IressaDrug: Placebo
One pill po once daily
Other Name: Sugar pill
- 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 treatment arms.
- 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 unacceptable toxicity.
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.
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Gary N. Schwartz, MD||Norris Cotton Cancer Center|