Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

What Was Tested

The trial (phase 3) is built around Goserelin.

The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

It had two arms (groups): A (no intervention) and B (experimental).

Patients receiving only adjuvant chemotherapy.

Patient receiving goserelin acetate along with adjuvant chemotherapy.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 102 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: Pathologically confirmed invasive breast carcinoma. Candidates for adjuvant chemotherapy for primary breast cancer. Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: previous systemic chemotherapy; stage iv breast cancer.

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.

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

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It ran at 3 sites in Turkey (Türkiye) (3).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles (time frame: Each 3 months).

It also tracked 1 secondary outcome, for example Quality of life (QOL) through-out the study measured by FACT-ES scale.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 102 people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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