A randomised factorial trial of sequential doxorubicin and CMF vs CMF and chemotherapy alone vs chemotherapy followed by goserelin plus tamoxifen as adjuvant treatment of node-positive breast cancer

What Was Tested

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

The study used a 2 x 2 factorial experimental design to assess: (1) the effect of the chemotherapy regimens (CMF vs A --> CMF or arms a+c vs b+d) and (2) the effect of adding GT after chemotherapy (arms a+b vs c+d).

Why It Was Studied

The sequential doxorubicin --> CMF (CMF=cyclophosphamide, methotrexate, fluorouracil) regimen has never been compared to CMF in a randomised trial.

The role of adding goserelin and tamoxifen after chemotherapy is unclear.

Who Took Part

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

In all, 466 premenopausal node-positive patients were randomised to: (a) CMF x 6 cycles (CMF); (b) doxorubicin x 4 cycles followed by CMF x 6 cycles (A --> CMF); (c) CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (CMF --> GT); and (d) doxorubicin x 4 cycles followed by CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (A --> CMF --> GT).

How the Study Was Run

In design terms this was a randomized study.

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

What Was Measured

Topics PubMed links to this paper include Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Combined Modality Therapy, Cyclophosphamide, Disease-Free Survival and Doxorubicin.

What This Means in Plain Language

The paper is a randomized study of Goserelin.

The publication is from 2005 (British journal of cancer), a journal based in England.

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