CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
leuprolide +2 moredrug
Likely dose
leuprolide 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00903162
NCT00903162Phase 2Completed

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Dana-Farber Cancer Institute·interventional·Posted May 18, 2009·Updated Apr 18, 2016

In Brief

A Phase 2 clinical trial evaluating leuprolide, letrozole, and 1 other intervention for Breast Cancer. Completed, enrolled 17 participants across 4 sites.

Detailed Summary

The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer recurrence in postmenopausal women with breast cancer who have been previously treated with tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is known as ovarian function suppression. Stopping a women's menstrual cycle may be effective against breast cancer for some patients when given as initial therapy. The combination of letrozole and leuprolide is considered a standard treatment for women with metastatic breast cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer, but it has not been accepted as a standard of care treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.1 years ago

Interventions

leuprolidedrug

Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years

letrozoledrug

Taken orally once a day 6-8 weeks after initial leuprolide administration

zoledronic aciddrug

If desired, given intravenously every 6 months for a total of 4 injections (optional)