CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
Tamoxifen +2 moredrug
Likely dose
Ribociclib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02586675
NCT02586675Phase 1Completed
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The TEEL Study: A Phase I Trial of Tamoxifen With Ribociclib (LEE011) in Adult Patients With Advanced ER+ (HER2 Negative) Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Oct 26, 2015·Updated Jan 21, 2022

In Brief

A Phase 1 clinical trial evaluating Tamoxifen, Ribociclib, and 1 other intervention for Breast Cancer and 2 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Cancer - Female, Breast Cancer - Male
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 26, 2015
Enrollment StartFeb 23, 2016
Primary CompletionMay 8, 2017
Study CompletionOct 27, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.7 years ago

Interventions

Tamoxifendrug

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

Ribociclibdrug

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).

Goserelindrug

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.