Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)

What Was Tested

This registered phase 2 trial tested Goserelin.

The registry classes the interventions as drug.

More on the Plan

Study Design: Prospective, randomized, open phase II trial Schedule: All patients will receive an anthracycline-containing polychemotherapy.

Goserelin will be given as a subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) until the end of the last chemotherapy cycle.

Secondary objectives: To compare the two treatment groups regarding * Compliance to treatment * Toxicity * Quality of life * Menopausal Symptoms Score * Ovarian function at 6, 12, 18 and 24 months * Duration until recovery of regular menstrual period * Pregnancy rate.

Who Took Part

Enrollment: 62 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: Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. Complete baseline documentation sent to GBG. Age of at least 18 and at most 45 years. Patients request to preserve ovarian function. Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase.

The full record lists 12 inclusion and 8 exclusion criteria; among the exclusions: known hypersensitivity reaction to the investigational compounds or incorporated substances; prior cytotoxic treatment for any reason; suspected (primary or secondary) ovarian insufficiency.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2005-03 with completion listed for 2008-12.

It ran at 1 site in Germany.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Normal ovarian function as defined by two consecutive menstrual periods within 21-35 days within a time frame of 5 - 8 months after last application of goserelin (time frame: December 2008).

It also tracked 7 secondary outcomes, for example Discontinuation or delay of Goserelin injections, Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin, Evaluation according to EORTC Q 30, According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months, Date of first regular menstrual period and Any diagnosis of pregnancy during study follow up.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 62 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.