Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group).

It had two arms (groups): standard chemotherapy with goserelin (experimental) and standard chemotherapy without goserelin (active comparator).

Standard chemotherapy with the GnRH agonist goserelin.

Standard chemotherapy without goserelin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 98 actual participants took part.

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: The patients signed the written informed consent. Histologically proven stage I, II, or III breast cancer. Must be candidates for adjuvant or neoadjuvant chemotherapy,. Must be premenopausal. Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: the patients were previous chemotherapy;; evidence of distant metastases;; other malignancies in the previous 5 years.

How the Study Was Run

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

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 started in 2015-06 with completion listed for 2016-11.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): ovarian failure (time frame: 2 years).

It also tracked 5 secondary outcomes, for example Ovarian dysfunction, Time to the resumption of menstrual activity, pregnancy, DFS OS and FSH,E2,AMH.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 98 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.