drugset / Trial / NCT01614210
Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.
Timeline
- Start
- 2012-08
- Primary completion
- 2016-11
- Completion
- 2016-11
Outcome
Met primary endpoint
registry MEAN Tamoxifen Pre and Post Breast Surgery: -40 (-63 to -29) percentage change in Ki67 NCT01614210 ↗
registry analysis (other test); Tamoxifen Pre and Post Breast Surgery; p = 0.0001; t-test, 1 sided NCT01614210 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tamoxifen | Small molecule | 20 mg | Oral |