Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
Post-Menopausal, Breast Cancer
About this trial
This is an interventional prevention trial for Post-Menopausal focused on measuring letrozole, breast cancer, menopause
Eligibility Criteria
Inclusion Criteria: Postmenopausal status defined as: women >55 years of age-no spontaneous menses for at least 12 months; in women < 55 years-no spontaneous menses within the past 12 months and with an FSH level >34.4 IU/I; bilateral oophorectomy If subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal Baseline mammogram (within 6 months) indicating mammographic density occupying >25% (grade 4/5, 5/6 or 6/6) of the breast tissue Baseline breast examination demonstrating no clinical evidence of breast cancer Acceptable quality DEXA of the L2-L4 postero-anterior (PA) spine and hup must be performed 6 months of randomization Subject is willing and able to complete the quality of life questionnaire in either English or French Exclusion Criteria: Mammogram suspicious for breast cancer (unless subsequently ruled out) Patient's with prior malignancies are eligible unless they have metastatic disease Uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome Current chemotherapy or immunotherapy Hormone replacement therapy or Evista (raloxifene) discontinued less than three months before baseline mammogram Tamoxifen therapy discontinued less than six months prior to randomization
Sites / Locations
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center