Fulvestrant in Metastatic Breast Cancer

What Was Tested

In this phase 4 trial, researchers set out to test Goserelin.

This is a prospective study of the role of fulvestrant in combination with ovarian function suppression as first-line therapy in premenopausal patients with metastatic hormone receptor-positive breast cancer.

It had 1 arm (groups): fulvestrant arm (experimental).

Patients will receive fulvestrant + zoladex intramuscular monthly with an assessment every three months to assess the response and progression.

The registry classes the interventions as drug.

More on the Plan

Hormone receptor-positive breast cancer is the most common presentation of breast cancer today.

Endocrine therapy is the preferred treatment modality in hormone receptor-positive early stage and advanced breast cancer.

Fulvestrant is an estrogen receptor antagonist indicated for the treatment of postmenopausal women with estrogen receptor-positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antiestrogen therapy, or disease progression on therapy with an antiestrogen.

Fulvestrant is a selective estrogen receptor down-regulator that competitively binds to estrogen receptors, with a binding affinity approximately 100 times greater than that of tamoxifen.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to women only aged from 30 years up to 55 years.

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

Examples of who could join: Women with age 30-50 years old (premenopause). Histological confirmation of metastatic disease. Hormonal receptor positive. Endocrine therapy for early disease had been completed more than 12 months before the study (patients who was not resistance to hormonal therapy). Metastatic breast cancer at presentation.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: patient \>55 years old; non-histologically diagnosed; hormonal receptor negative.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Goserelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-08-01 with completion listed for 2021-08-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression free survival (time frame: three years).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Goserelin in 30 people.

Its size is small, so on its own it can only give an early look.

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.