Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial

What Was Tested

The paper reports a study of Goserelin, published as a randomized controlled trial.

In an International Breast Cancer Study Group (IBCSG) randomized clinical trial (Trial VIII) for pre- and perimenopausal women with lymph node-negative breast cancer, the researchers compared sequential chemotherapy followed by the gonadotropin-releasing hormone agonist goserelin with each modality alone.

Who Took Part

The abstract describes 1999, patients taking part.

By PubMed's age tags, the people studied were adults and middle-aged adults, women only.

From March 1990 through October 1999, 1063 patients stratified by estrogen receptor (ER) status and radiotherapy plan were randomly assigned to receive goserelin for 24 months (n = 346), six courses of "classical" CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or six courses of classical CMF followed by 18 months of goserelin (CMF --> goserelin; n = 357).

A fourth arm (no adjuvant treatment) with 46 patients was discontinued in 1992.

How the Study Was Run

In design terms this was a randomized study.

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

The timeline in the abstract includes 24 months.

Twenty percent of patients were aged 39 years or younger.

The median follow-up was 7 years.

The primary outcome was disease-free survival (DFS).

What Was Measured

PubMed files the paper under topics including Amenorrhea, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Confidence Intervals and Cyclophosphamide.

What This Means in Plain Language

The paper is a randomized study of Goserelin in 1999, patients over 24 months.

With several hundred people or more, it is a fairly large study for this kind of research.

Its findings take up roughly 4 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2003 (Journal of the National Cancer Institute), a journal based in United States.

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