Breast Cancer Clinical Trial
Official title:
A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
Verified date | January 2007 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year. | |||
Secondary | To determine if the decrease in breast density grade is sustained one year after cessation of therapy | |||
Secondary | to determine if there is a correlation between plasma estrogen profile and breast density at baseline | |||
Secondary | to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy | |||
Secondary | to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy | |||
Secondary | to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year | |||
Secondary | to compare the effects on menopause-specific quality of life. |
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