Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

Secondary Objectives: * To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy. * To determine the overall survival and disease-free survival times of study participants.

It had two arms (groups): Goserelin (experimental) and No Goserelin (no intervention).

The registry classes the interventions as drug.

More on the Plan

Goserelin is designed to block hormones that can regulate your menstruation by affecting the pituitary gland (part of brain).

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups.

You will either be assigned to receive goserelin or no treatment.

There is an equal chance of being assigned to either group.

Who Took Part

Enrollment: 1 actual participants took part.

It was open to women only aged from 15 years up to 46 years.

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

Examples of who could join: Female patients older than 15 years and younger than 46 years. Pathologically confirmed invasive breast carcinoma. Premenopausal, verified before chemotherapy is begun as satisfying both:. Cyclic vaginal bleeding. Treatment with at least four (4) cycles of chemotherapy as planned.

The full record lists 12 inclusion and 7 exclusion criteria; among the exclusions: pregnancy. women must have a negative serum pregnancy test before initiation of injection; hypersensitivity to any gnrh analog; previous receipt of systemic chemotherapy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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 2006-08 with completion listed for 2010-07.

It ran at 2 sites in United States (1) and Japan (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Patients With Response (FSH Level + Vaginal Bleeding) (time frame: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 1 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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