PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

What Was Tested

The trial (phase 3) is built around Goserelin.

It had two arms (groups): Palbociclib + Tamoxifen ± Goserelin (experimental) and Placebo + Tamoxifen ± Goserelin (active comparator).

The registry classes the interventions as drug.

Who Took Part

180 planned participants were the target.

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: Any menopausal status. Measurable disease or non-measurable disease as defined by RECIST ver.1.1. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: prior treatment with any cdk inhibitor, tamoxifen, everolimus, or agent that inhibits the pi3k-mtor pathway; patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic cns metastases; use of strong or moderate cyp3a4 and/or cyp2d6 inhibitors or inducers.

How the Study Was Run

The set-up was 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.

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

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

It started in 2018-02-09 with completion listed for 2025-09.

It ran at 23 sites in Japan (12), South Korea (6), Taiwan (3) and Singapore (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression-free survival (PFS) (time frame: Baseline up to 3.5 years).

It also tracked 10 secondary outcomes, for example Overall Survival (OS), Survival Probabilities at 1 year, 2 year, and 3 year, Objective Response (OR), Duration of Response (DR), Trough plasma concentrations of palbociclib and Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 180 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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