Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer

Status unconfirmed · Phase 2

Conditions studied: Post-Menopausal, Breast Cancer

In brief

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.

Key facts

Study ID: NCT00280930
Run by: Dana-Farber Cancer Institute
People needed: 60
Starts: 2005-10-01
Last updated by the study team: 2007-01-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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