NCT02586675 - TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 23, 2016

Primary Completion Date

May 8, 2017

Study Completion Date

October 27, 2021

Conditions

Breast CancerBreast Cancer - FemaleBreast Cancer - Male

Interventions

DRUG

Tamoxifen

Tamoxifen will be taken orally once daily on a continuous daily schedule (e.g., days 1-28 of each 28 day cycle).

DRUG

Ribociclib

"Ribociclib (LEE011) will be taken orally once daily on days 1-21 of each 28 day cycle. Days 22-28 will be a rest period from dosing with Ribociclib. In the continuous cohort, 400 mg ribociclib will be given daily (QD)."

DRUG

Goserelin

Goserelin will be given as an injectable subcutaneous implant on day 1 of every 28 day cycle. This will be given in pre-menopausal and peri-menopausal women.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa