Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.