drugset / Trial / NCT00080743
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
Phase 2
Completed
2 enrolled
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI) · collabNorris Cotton Cancer Center · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2004-01
- Primary completion
- 2005-04
- Completion
- 2005-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gefitinib | Small molecule | 250 mg | Oral |
| Comparator | Tamoxifen | Small molecule | 20 mg | Oral |