Fulvestrant (F)/Goserelin (G) vs Anastrozole (A)/G vs G for Premenopausal Women

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

Fulvestrant is an ER antagonist with no agonist effects, which binds, blocks and degrades the ER.

It had three arms (groups): Fulvestrant plus Goserelin (experimental), Anastrozole plus Goserelin (experimental) and Goserelin alone (active comparator).

The registry classes the interventions as drug.

More on the Plan

This randomized phase II trial is studying fulvestrant with goserelin for ovarian suppression by goserelin to see how well it works compared to anastrozole with goserelin and goserelin alone in recurrent or metastatic ER-positive breast cancer.

Who Took Part

The registry lists 147 planned participants were the target.

It was open to women only aged up to 55 years.

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

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: patients who had received previous treatment for metastatic disease (including systemic cytostatic or hormonal treatment) other than tamoxifen; lymphangitic pulmonary metastases; multiple or diffuse hepatic metastases.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Goserelin group and the comparison group ran side by side rather than switching.

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

It started in 2010-12 with completion listed for 2018-06.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Progression (TTP) (time frame: from the date of therapy to the date of progression every 3 months).

It also tracked 3 secondary outcomes, for example overall response, overall survival and Toxicity.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 147 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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