Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

What Was Tested

The trial (phase 2) is built around Goserelin.

To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer.

It had two arms (groups): one (experimental) and Combination Chemotherapy (active comparator).

Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.

The registry classes the interventions as combination product and drug.

More on the Plan

The study consisted of a 28-day Screening phase, treatment phase (including end of treatment (EOT) visit and safety follow-up), and survival follow-up.

Who Took Part

The registry lists 222 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: Patient was an adult female ≥ 18 years old and \< 60 years old at the time of informed consent. Symptomatic visceral metastases. Rapid progression of disease or impending visceral compromise. Markedly symptomatic non-visceral disease if the treating physician opted to give chemotherapy for rapid palliation of patient's symptoms. Patient was premenopausal or perimenopausal at the time of study entry.

The full record lists 15 inclusion and 12 exclusion criteria; among the exclusions: patient received prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy, or any cdk4/6 inhibitor for advanced breast cancer); patients who had lung metastases with oxygen demand in resting status; patients who had liver metastases with bilirubin \> 1.5 uln.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2019-02-25 with completion listed for 2022-04-12.

It ran at 50 sites in Taiwan (8), Turkey (Türkiye) (7), India (6), Malaysia (5), Egypt (4) and Russia (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression-free Survival (time frame: Up to approximately 34 months).

It also tracked 10 secondary outcomes, for example Time to Treatment Failure, 3-month Treatment Failure Rate, Overall Response Rate (ORR), Time to Response, Overall Survival (OS) and Number of Patients With Adverse Events, Categorized by Severity.

What This Means in Plain Language

Put simply, this is a phase 2, 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.