S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

What Was Tested

This registered phase 3 trial tested Goserelin.

RATIONALE: Goserelin blocks hormone production in the ovaries.

It had two arms (groups): Standard Chemotherapy (active comparator) and Chemotherapy Plus Goserelin (experimental).

Patients receive cyclophosphamide-containing chemotherapy alone.

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.

The registry classes the interventions as drug.

More on the Plan

Secondary * Compare the rate of ovarian dysfunction in patients treated with these regimens. * Compare ovarian reserve in patients treated with these regimens. * Describe the pregnancy rates in patients treated with these regimens.

OUTLINE: This is a randomized study.

Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based).

Patients are randomized to 1 of 2 treatment arms. * Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone.

Who Took Part

257 actual participants took part.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:. 3-month/4-course anthracycline-based regimen. 6- to 8-month/course anthracycline-based regimen. 6- to 8-month/course non-anthracycline-based regimen. Hormone receptor status:.

The full record lists 29 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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.

Being open-label, the Goserelin study did not mask who received what.

It started in 2003-10 with completion listed for 2014-01.

It ran at 34 sites in Australia (14), Switzerland (7), Belgium (6), Italy (5), Hungary (1) and New Zealand (1).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Rate of Premature Ovarian Failure at 2 Years (time frame: 2 years).

It also tracked 2 secondary outcomes, for example Rate of Ovarian Dysfunction at 2 Years and Rate of Ovarian Dysfunction at 1 Year.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 257 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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