NCT02586675

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase I Dose Escalation: The phase I portion of the study is a dose escalation to confirm the safety of the combination and to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) for ribociclib with Tamoxifen. Phase I will be conducted in all participants with Hormone Receptor Positive (HR+)/Human Epidermal growth factor Receptor 2 Negative (HER2-) locally advanced or metastatic breast cancer with any prior endocrine therapy and up to three prior cytotoxic chemotherapy regimens administered in the metastatic or locally advanced setting. Phase Ib Dose Expansion: Phase I trials are increasingly including dose-expansion cohorts (Ib) after the maximum-tolerated dose has been reached to better characterize the toxicity profile and identify early signs of efficacy within this specific disease population. The investigators' goal is to assess the anti-tumor activity Ribociclib + Tamoxifen and to further evaluate their safety in adult patients with HR+/HER2- locally advanced or metastatic breast cancer. Patients in the phase 1b expansion will have the same exclusion and inclusion criteria except that they will only be allowed to have up to two lines of cytotoxic chemotherapy in the metastatic setting.

Conditions

• Breast Cancer
• Breast Cancer - Female
• Breast Cancer - Male

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-23
• Primary completion: 2017-05-08
• Completion: 2021-10-27
• First posted: 2015-10-26
• Last updated: 2022-01-21
• Results posted: 2019-06-03

Locations

1 site across 1 country: United States