Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer

What Was Tested

This registered phase 3 trial tested Goserelin.

The registry classes the interventions as drug and procedure.

More on the Plan

OBJECTIVES: Primary * Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .

Patients are stratified according to age (≤ 40 years vs \> 40 years) and participating center.

Patients are randomized to 1 of 2 treatment arms.

Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy.

Who Took Part

400 planned participants were the target.

It was open to women only.

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

Examples of who could join: Histologically confirmed invasive breast cancer. Stages I-IIIB with node-positive or -negative disease (N0-2). Must meet 1 of the following criteria:. Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks. Scheduled to receive neoadjuvant chemotherapy.

The full record lists 19 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized and open-label.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

It started in 2004-08.

It ran at 66 sites in United Kingdom (66).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months.

It also tracked 6 secondary outcomes, for example Incidence of menopausal symptoms, Quality of life, Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers, Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy and Incidence of pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 400 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.