Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial

What Was Tested

The paper reports a study of Goserelin, published as a randomized controlled trial.

Who Took Part

By PubMed's age tags, the people studied were adults and middle-aged adults, women only.

In this phase 3, randomised, double-blind, parallel-group, multicentre study, the researchers enrolled premenopausal women with oestrogen receptor (ER)-positive, HER2-negative, operable breast cancer with WHO performance status of 2 or lower.

Patients were randomised sequentially, stratified by centre, with randomisation codes.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, multicenter and parallel-group study.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Goserelin.

The comparison arm used a placebo, so changes seen with Goserelin could be set against what happens without it.

More than one site took part, so the participants came from several places.

A time span of 5 years appears in the methods.

All study personnel were masked to study treatment.

The primary endpoint was best overall tumour response (complete response or partial response), assessed by callipers, during the 24-week neoadjuvant treatment period for the intention-to-treat population.

The researchers included all patients who received study medication at least once in the safety analysis set.

The researchers report the primary analysis; treatment will also continue in the adjuvant setting for 5 years.

This trial is registered with ClinicalTrials.gov, number NCT00605267.

What Was Measured

Topics PubMed links to this paper include Anastrozole, Antineoplastic Combined Chemotherapy Protocols, Aromatase Inhibitors, Breast Neoplasms, Goserelin, Neoadjuvant Therapy and Neoplasm Staging.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Goserelin over 5 years.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2012 (The Lancet. Oncology), a journal based in England.

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