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Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study)

Plain-language guide to PMID 30223226 (2018): open-label randomized controlled trial study of Goserelin.

Key Facts

PMID
30223226
Journal
European journal of cancer (Oxford, England : 1990)
Year
2018
Study type
Randomized Controlled Trial
Authors
Kim JY et al. (18 authors)
DOI
10.1016/j.ejca.2018.08.004

What This Study Did, in Plain Language

What Was Tested

Researchers studied Goserelin in this randomized controlled trial publication.

ClinicalTrials.gov number NCT01266213 and Korean Cancer Study Group (KCSG) Breast cancer protocol number BR10-04.

Who Took Part

PubMed indexes the participants as adults, women only.

In this multicentre, open-label, randomised phase II study, premenopausal women aged ≥18 years with HR+, HER2-, tamoxifen-pretreated MBC were randomly assigned (1:1:1) to F + G, A + G or G alone.

How the Study Was Run

The design is described as randomized, open-label and multicenter.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

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

More than one site took part, so the participants came from several places.

The primary end-point was time to progression (TTP).

What Was Measured

The subject headings attached to it are Anastrozole, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Fulvestrant, Goserelin and Neoplasm Metastasis.

The authors tagged it with the keywords Endocrine therapy, Metastatic breast cancer and Premenopausal.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Goserelin.

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (European journal of cancer (Oxford, England : 1990)), a journal based in England.

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

Our Notes on the Compound

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.