Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years.

Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved.

It had 1 arm (groups): Letrozole-Leuprolide (experimental).

The registry classes the interventions as drug.

More on the Plan

* Participants will be given a monthly intramuscular injection of leuprolide.

Six to eight weeks after the first leuprolide injection, participants will be instructed to begin taking letrozole pills by mouth at home each day. * During this research study, participants will also be offered injections of zoledronic acid to preserve bone mineral density.

Who Took Part

17 actual participants took part.

It was open to women only 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: Women 18 years of age or older. Premenopausal (estradiol level in premenopausal range, \>20pg/ml, within the prior 28 days). Liver function tests and creatinine \<2.5 times the upper limit of normal within the 28 days prior to enrollment. ECOG Performance Status 0-1. Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: previous treatment with an oral or iv bisphosphonate in the prior two years; pregnant women; nursing women.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

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

It started in 2009-05 with completion listed for 2014-07.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 17 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 Leuprolide compound page, all human trials.