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

What Was Tested

This registered phase 1 trial tested Goserelin.

It had 1 arm (groups): Tamoxifen and Ribociclib with Goserelin (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

7 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Measurable disease, i.e., at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria only \*for expansion cohorts. For \*escalation cohorts, bone only disease is allowed. For expansion cohorts, there must be measurable disease as stated above. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1. Written informed consent must be obtained prior to any screening procedures and according to local guidelines. Adequate bone marrow and organ function.

The full record lists 12 inclusion and 22 exclusion criteria; among the exclusions: prior cdk 4/6 inhibitor exposure; have received tamoxifen in the metastatic setting (for more than 30 days) or has progressed while on tamoxifen in the adjuvant setting; known hypersensitivity to ribociclib or excipients of tamoxifen.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-02-23 with completion listed for 2017-05-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Progression-free Survival (PFS) at Six Months and Overall Survival (OS) at Six Months.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Goserelin in 7 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Goserelin compound page, all human trials.