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

What Was Tested

The trial (phase 3) is built around Goserelin.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 434 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: Patients must meet all of the following conditions:. Postmenopausal or premenopausal / peri-menopausal females aged≥18 years;. Postmenopausal female is defined as:. There should be evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy for curative purposes, and without clinical indications for chemotherapy;。. ECOGperformance status 0-1。.

The full record lists 19 inclusion and 20 exclusion criteria; among the exclusions: patients who meet any of the following conditions are not allowed to enter this clinical study：; previously treated with cdk4 / 6 inhibitors;; disease progression orrecurrence during or within 12 months after receiving neoadjuvant therapy or adjuvant therapy with endocrine drugs;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

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 2022-03-02 with completion listed for 2024-09-20.

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 IRC (time frame: 3 years).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 434 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.