Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

What Was Tested

This registered phase 3 trial tested Goserelin.

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

It had two arms (groups): Ribociclib + NSAI/tamoxifen + goserelin (experimental) and Placebo + NSAI/tamoxifen + goserelin (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Eligible participants were randomized in a 1:1 ratio to either the ribociclib arm or the placebo arm.

All participants who discontinued treatment were followed for survival until the predetermined number of overall survival (OS) events was reached.

Cross-over was optional and was conducted at the investigator's discretion and upon participant consent.

Who Took Part

672 actual participants took part.

It was open to women only aged from 18 years up to 59 years.

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

Examples of who could join: Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. Patients were premenopausal or perimenopausal at the time of study entry. Patients who had received (neo) adjuvant therapy for breast cancer were eligible. Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer. Patients had HER2-negative breast cancer.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: patients who had received a prior cdk4/6 inhibitor; patients were postmenopausal; patients who currently had inflammatory breast cancer at screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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

Neither the participants nor the staff measuring them knew who was on Goserelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-11-20 with completion listed for 2017-08-21.

It ran at 183 sites in United States (35), Italy (20), Spain (17), Germany (12), France (8) and Taiwan (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression Free Survival (PFS) by Investigator Assessment.

It also tracked 8 secondary outcomes, for example Overall Survival (OS), Overall Response Rate (ORR) by Investigator Assessment, Time to Response (TTR) by Investigator Assessment, Duration of Response (DOR) by Investigator Assessment, Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score and Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 672 people.

With 672 participants it is a large trial for this field.

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.