Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.
Timeline
- Start
- 2002-02-19
- Primary completion
- 2009-07-31
- Completion
- 2011-06-30
Outcome
Mixed primary results
registry MEDIAN Tamoxifen or Letrozole: -5.0 (-10.4 to 0.4) change in tumor volume (mm) NCT00290745 ↗
registry analysis (other test); Tamoxifen or Letrozole; p = 0.07; Wilcoxon (Mann-Whitney) NCT00290745 ↗
registry MEDIAN Tamoxifen or Letrozole: -0.8 (-1.95 to 0.35) change in tumor volume (cm3) NCT00290745 ↗
registry analysis (other test); Tamoxifen or Letrozole; p <0.001; Wilcoxon (Mann-Whitney) NCT00290745 ↗
Publications
- Background Chen YY, DeVries S, Anderson J, Lessing J, Swain R, Chin K, Shim V, Esserman LJ, Waldman FM, Hwang ES. Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer. 2009 Aug 18;9:285. doi: 10.1186/1471-2407-9-285.
- Background Swain RS, Chen YY, Wa C, et al.: Pathologic and biologic response to neoadjuvant anti-estrogen (AE) therapy in patients with ductal carcinoma in situ (DCIS). [Abstract] United States and Canadian Academy of Pathology 95th Annual Meeting, February 11-17, 2006, Atlanta, GA. A-186, 2006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | — | Oral |
| Subject | Tamoxifen | Small molecule | — | Oral |