Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

Breast Cancer Clinical Trial

Official title: Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women

Status Completed

Clinical Trial Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may prevent breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with zoledronate may prevent breast cancer and reduce bone loss.

PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density.

Clinical Trial Description

OBJECTIVES:

Primary

• Compare the percent change in breast density in healthy postmenopausal women with high breast density treated with placebo only vs letrozole and placebo vs letrozole and zoledronate.

• Compare the percent change in biochemical markers of bone turnover in participants treated with these regimens.

Secondary

• Compare the bone density in participants treated with these regimens.

• Compare growth hormone release and insulin-like growth factor levels in participants treated with these regimens.

• Compare the incidence and severity of adverse events in participants treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, pilot study. Participants are stratified according to prior hormone replacement therapy (HRT) use (discontinued HRT > 5 years ago or no prior HRT use vs discontinued HRT 1-5 years ago). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Participants receive oral placebo once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months.

• Arm II: Participants receive oral letrozole once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months.

• Arm III: Participants receive oral letrozole once daily for 12 months and zoledronate IV over 15 minutes on day 0 and at 6 months.

In all arms, treatment continues in the absence of unacceptable toxicity.

After completion of study treatment, participants are followed at 3 months.

PROJECTED ACCRUAL: A total of 120 participants (40 per treatment arm) will be accrued for this study. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Osteoporosis

• NCT number: NCT00114270
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: N/A
• Start date: May 2004
• Completion date: June 2007