Upregulation of HER-2/neu by ovarian ablation: results of a randomized trial comparing leuprorelin to CMF as adjuvant therapy in node-positive breast cancer patients

What Was Tested

This randomized controlled trial looks at Leuprolide.

HER-2/neu oncogene expression is modulated by an estrogen-sensitive binding site in the HER-2/neu promoter.

Utilizing the circulating antigen of HER-2/neu in serum (sHER-2/neu) as a surrogate marker the researchers investigated whether ovarian ablation by adjuvant therapy leads to an upregulation of HER-2/neu in breast cancer patients.

Who Took Part

The study group was 80 patients.

PubMed indexes the participants as adults and middle-aged adults, women only.

The analysis was done on sera from premenopausal, node-positive, hormone-receptor positive patients randomized in a multi-center trial.

Sera, available from 80 patients in the leuprorelin arm and from 53 patients in the CMF arm, were collected at 0, 3, 6, 12, 18, 24 and 30 months. sHER-2/neu was measured using a standardized ELISA assay that has an upper limit of normal of 15 ng/ml. sHER-2/neu results were correlated to the levels of LH, FSH and estradiol as indicators of ovarian ablation and to the tumor marker, CA 27.29.

How the Study Was Run

In design terms this was a randomized study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

What Was Measured

Topics PubMed links to this paper include Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Cyclophosphamide, Disease-Free Survival and Fluorouracil.

What This Means in Plain Language

The paper is a randomized study of Leuprolide in 80 patients.

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 2003 (Breast cancer research and treatment), a journal based in Netherlands.

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