Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
- Participants will be given a monthly intramuscular injection of leuprolide. Six to
eight weeks after the first leuprolide injection, participants will be instructed to
begin taking letrozole pills by mouth at home each day.
- During this research study, participants will also be offered injections of zoledronic
acid to preserve bone mineral density. If desire, these injections will be given every
6 months for a total of 4 injections during the course of the research study.
- The treatments in this research study may increase the risk of bone density loss, so
vitamin D and calcium supplements will be recommended to participants.
- The following tests and procedures will be performed during the research study:
Physical Exam (every visit); Blood tests; Urine test (beginning and end of treatment);
Imaging (annual mammograms); Bone Density (DXA) Scan (beginning and end of treatment);
Questionnaires (throughout the study).
- Participants will be on this study for about two years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population.
Kathryn Ruddy, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|University of Colorado||Denver, Colorado 80217|
|Newton Wellesley Hospital||Newton, Massachusetts 02462|