Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

It had five arms (groups): one (experimental), one (active comparator), one (no intervention), TAM(B) (active comparator) and TAM+OFS (C) (experimental).

The registry classes the interventions as drug.

Who Took Part

1234 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Patients must be within 3 months after the last cycle of chemotherapy. Patients must have the history of normal menstruation prior to the start of chemotherapy. Stage I, II or III. Woman, less than or equal to 45 years of age. Hormone receptor status : ER+ve and/or PgR+ve.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: ER(-),ER unknown; patients with the history of hysterectomy or oophorectomy; investigational drugs given within the previous 4 weeks.

How the Study Was Run

Design: randomized, factorial and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

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.

It started in 2009-05 with completion listed for 2015-12.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: all cause recurrence (time frame: the first 5 years after surgery).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 1234 people.

With 1234 participants it is a large trial for this field.

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.