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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) AstraZeneca |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00295100 |
The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial. Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication. The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Tamoxifen |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Cancer Risk and Biomarkers of Tamoxifen Chemoprevention |
Estimated Enrollment: | 78 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | July 2006 |
The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial.
The study outcomes will be biological markers, rather than cancer incidence or mortality. Eligible study subjects will be women, between the ages 25-45, whose calculated lifetime breast cancer risk is > 20% (25% by the Couch model).
Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication.
The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram. Mammographic density has been correlated with breast cancer risk and reduced breast density may have the added benefit of improving the sensitivity of breast cancer screening in young women. Breast density will be employed as a marker of progression-related - proliferative - mechanisms of carcinogenesis.
Secondary study outcomes will include estrogen ratios (catechol estrogen/estradiol), and markers of oxidative DNA damage in peripheral blood and urine (markers of progression-related – mutational - events in carcinogenesis). The responsiveness of these outcomes will suggest the mechanisms through which tamoxifen exerts its preventive effect. Persistence of the markers after one year of treatment may also provide early information about the anticipated duration of the tamoxifen effect.
Ages Eligible for Study: | 25 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Study participants will include healthy pre-menopausal women, ages 25 to 45 who meet all of the following eligibility criteria:
Exclusion Criteria:
Study participants will be excluded if any of the following conditions occur:
Deferral Criteria:
Study participants will be deferred from the study for the time period stated if any of the following conditions occur.
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
Italy | |
European Institute of Oncology | |
Milan, Italy |
Principal Investigator: | Susan Domchek, MD | University of Pennsylvania |
Study ID Numbers: | 278100, UPC 2100 |
Study First Received: | February 20, 2006 |
Last Updated: | June 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00295100 |
Health Authority: | United States: Institutional Review Board |
Tamoxifen Prevention Breast Cancer MRI |
Skin Diseases Breast Neoplasms Tamoxifen Breast Diseases |
Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |