A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
Data Collection
Collected from today forward - ProspectiveBreast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction. * Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug. * Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug. Secondary * Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients. * Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug. OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction). Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.53 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 20 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction * Undergoing mammography at least annually * No bilateral breast cancer or stage IV breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 20 to 45 Sex * Female Menopausal status * Premenopausal * No change in menstrual patterns within the past 6 months Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * No planned pregnancy within the next 5 years * No medical or psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for breast cancer Endocrine therapy * See Disease Characteristics * No prior tamoxifen for more than 1 month in duration Radiotherapy * Not specified Surgery * Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesSee the location