Trial Information

A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women

OBJECTIVES:

Primary

- Determine the effect of 4-hydroxytamoxifen gel on breast density, as measured by
digital mammography, in premenopausal women.

- Determine the effect of this gel on breast density in these participants, as defined by
the BIRADS lexicon.

Secondary

- Determine the effect of this gel on salivary sex steroid levels in these participants.

- Determine the effect of this gel on quality of life of these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are
randomized to 1 of 2 treatment arms.

- Arm I: Participants apply 4-hydroxytamoxifen gel in 4 metered doses daily to each
breast beginning on the first day after cessation of the first menstrual period after
digital mammography is performed.

- Arm II: Participants apply placebo gel as in arm I. In both arms, treatment continues
for 1 year.

In both arms, participants collect daily saliva samples for 4 menstrual cycles during the
study. Three of the saliva collections occur during the cycles encompassing the time periods
when imaging studies are performed (months 0, 6, and 12). The fourth collection takes place
during the first month that gel is applied to the breast.

Participants also undergo digital mammography at baseline, 6 months, and 1 year.

Participants who develop clinical breast problems considered suspicious for cancer
discontinue study treatment until a histological diagnosis is established. Those found to
have breast cancer are removed from the study and those with benign disease continue the
study. If an excisional biopsy is performed, density measurements are made on the opposite
breast.

Quality of life is assessed at baseline, 1 month, 6 months, and 1 year.

PROJECTED ACCRUAL: A total of 100 participants (50 per treatment arm) will be accrued for
this study.