Study to Compare Zoladex™ [amount hidden] With Zoladex [amount hidden] in Pre-menopausal Women With Breast Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 222 actual participants took part.

It was open to women only aged from 20 years up to 130 years.

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

Examples of who could join: Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation. Hormone sensitivity (ER positive) of primary or secondary tumour tissue. Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: patients who have received lhrha as adjuvant therapy for breast cancer within 48 weeks before randomisation; patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or.

How the Study Was Run

Design: randomized, parallel-group 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.

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 2010-02-26 with completion listed for 2012-09-19.

It ran at 55 sites in Japan (19), India (15), Philippines (6), Thailand (6), Taiwan (5) and South Korea (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Patients With Progression-free Survival (PFS) at 24 Weeks.

It also tracked 2 secondary outcomes, for example Number of Responders at 24 Weeks and Oestradiol (E2) Serum Concentrations at 24 Weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 222 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.