Status:
UNKNOWN
Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Post-Menopausal
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 goa...
Detailed Description
* Patients will be randomized into one of two study groups. Group 1 will receive letrozole and Group 2 will receive placebo. This is a double-blind trial so neither the patient or the doctor will know...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00280930
Start Date
October 1 2005
Last Update
January 19 2007
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215