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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) Jonsson Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00090857 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels |
Estimated Enrollment: | 110 |
Study Start Date: | September 2000 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
Quality of life is assessed at baseline and then at 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued for this study.
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No evidence of suspicious or malignant disease, based on the following examinations:
Bone density scan within 2 standard deviations from normal within the past 30 days
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined by any of the following criteria:
Performance status
Life expectancy
Hematopoietic
Complete blood count with differential normal
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 30 days since prior AND no concurrent use of any of the following hormonal agents:
No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Judy Garber, MD 617-732-5500 judy_garber@dfci.harvard.edu | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 |
Principal Investigator: | Judy Garber, MD | Dana-Farber Cancer Institute |
Principal Investigator: | Patricia A. Ganz, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000375585, DFCI-00024, UCLA-0210012-02 |
Study First Received: | September 7, 2004 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00090857 |
Health Authority: | Unspecified |
breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer stage IV breast cancer breast cancer in situ ductal breast carcinoma in situ |
Skin Diseases Estradiol valerate Breast Neoplasms Letrozole Estradiol 17 beta-cypionate Estradiol Carcinoma |
Carcinoma in Situ Estradiol 3-benzoate Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Polyestradiol phosphate Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |