drugset / Trial / NCT02586675
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast cancer.
Timeline
- Start
- 2016-02-23
- Primary completion
- 2017-05-08
- Completion
- 2021-10-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 400 mg | Oral |
| Subject | Ribociclib | Small molecule | 600 mg | Oral |
| Background | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Background | Tamoxifen | Small molecule | 20 mg | Oral |