This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

It had two arms (groups): FCN-437c+Fulvestrant ± Goserelin acetate (experimental) and Placebo+ Fulvestrant ± Goserelin acetate (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

312 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: Arbitrary menopausal status.Postmenopausal female is defined as:. Previous treatment criteria: Second-line and above patients can be included in the group。. Previous treatment criteria: Second-line and above patients can be enrolled. Eastern cooperative oncology group (ECOG) 0-1。. Life expectancy is not less than 12 weeks;. Adequate bone marrow and organ function:.

The full record lists 17 inclusion and 20 exclusion criteria; among the exclusions: the exclusion criteria for prior treatment are as follows; patients who received prior treatment with any cdk4/6 inhibitors or fulvestrant or everolimus;; received more than first-line systemic chemotherapy for advanced breast cancer.;.

How the Study Was Run

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

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

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

As a double-blind Goserelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-01-18 with completion listed for 2024-02-18.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PFS is determined by the IRC (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 312 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.