Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 98 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer. World Health Organization (WHO) performance status of 0, 1, or 2. Provided written informed consent.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: treatment with tamoxifen or other hormonal therapies as early breast cancer (ebc) adjuvant in the previous 24 weeks; received radiotherapy within the past 4 weeks; history of systemic malignancy other than breast cancer within the previous 3 years.

How the Study Was Run

The set-up was 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.

The Goserelin group and the comparison group ran side by side rather than switching.

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

It started in 2006-04 with completion listed for 2009-11.

It ran at 14 sites in Russia (8), Ukraine (5) and Czechia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Progression Free Survival (PFS) at Week 24.

It also tracked 5 secondary outcomes, for example Objective Response Rate (ORR) at Week 24, Oestradiol (E2) Serum Concentrations at Week 24, Maximum Plasma Concentration, Cmax (ng/mL), Time to Maximum Plasma Concentration, Tmax (Hours) and Area Under the Plasma Concentration Curve (0-12 Weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 98 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.