Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Letrozole

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