Randomized double-blind 2 x 2 trial of low-dose tamoxifen and fenretinide for breast cancer prevention in high-risk premenopausal women.

Purpose: Tamoxifen and fenretinide are active in reducing premenopausal breast cancer risk and work synergistically in preclinical models. The authors assessed their combination in a two-by-two biomarker trial.

Patients And Methods: A total of 235 premenopausal women with pT1mic/pT1a breast cancer (n = 21), or intraepithelial neoplasia (IEN, n = 160), or 5-year Gail risk > or = 1.

Randomized dose-ranging trial of tamoxifen at low doses in hormone replacement therapy users.

Purpose: The combination of hormone replacement therapy (HRT) and low-dose tamoxifen may retain the benefits while reducing the risks of either agent. We assessed the optimal biologic dose and schedule of tamoxifen in HRT users using surrogate end point biomarkers and menopausal symptoms.

Subjects And Methods: Two hundred ten current or de novo HRT users were randomly assigned to one of the following four arms: tamoxifen 1 mg/day and placebo/week, placebo/day and tamoxifen 10 mg/week, tamoxifen 5 mg/day and placebo/week, or both placebos for 12 months.

Determinants of short term recurrence rate of endometriosis.

Objective: To analyse the frequency and the determinants of recurrence rate of clinically detectable endometriosis.

Study Design: Prospective cohort multicenter study. Eligible for the study were all women observed for the first time during the period January-June 1998 at the participating centres with a laparoscopically confirmed first diagnosis of endometriosis.