Goserelin/Letrozole in Premenopausal Patients vs Letrozole Alone in Postmenopausal Patients With MBC

What Was Tested

The trial (phase 2) is built around Goserelin.

It had two arms (groups): letrozole (experimental) and goserelin plus letrozole (active comparator).

The registry classes the interventions as drug.

More on the Plan

The sites of estrogen synthesis are the ovaries of premenopausal women and extragonadal sites such as fat, muscle, and skin, normal breast stromal cell and breast tumor tissue.

After ovarian failure, estrogen is synthesized in peripheral tissues such as fat and muscles and this peripheral aromatization in postmenopausal women is almost completely inhibited by single-agent administration of the third generation inhibitor (anastrozole, letrozole and exemestane etc).

In contrast, there is a barrier to using aromatase inhibitors as monotherapy in premenopausal women.

First, high level of androstenedione competes initially with the inhibitors as substrate for the enzyme complex.

Who Took Part

The registry lists 78 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: Positive estrogen receptor or progesterone receptor (\>grade 3/7 by modified Allred IHC score). Females at least 18 years of age and under 75 years. Prior chemotherapy for adjuvant setting or metastatic disease is allowed if the number of chemotherapy is ≤ 3. Prior adjuvant antiestrogen therapy is allowed, provided that had not been received within 3 weeks before the entry of the study. Prior adjuvant aromatase inhibitor therapy is allowed if the agent had not been given within one year of the entry.

The full record lists 16 inclusion and 2 exclusion criteria; among the exclusions: previous chemotherapy more than 3 including adjuvant therapy.

How the Study Was Run

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

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 2005-10 with completion listed for 2008-04.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Goserelin in 78 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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