17 Clinical Trials for Various Conditions
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in primary breast cancer prevention are not yet available. The hypothesis is that RANKL inhibition with denosumab will decrease mammographic density in high-risk premenopausal women with dense breasts. To address this, the investigators have developed this clinical trial to quantify the impact of RANKL inhibition on mammographic density in high-risk premenopausal women with dense breasts and to determine the effect of RANKL inhibition on markers of proliferation and biomarkers of breast cancer risk. Successful demonstration that RANKL inhibition reduces mammographic density could open up additional approaches to primary breast cancer prevention in high-risk premenopausal women, who do not have dominant genetic predisposition.
This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.
The objective of the study is to evaluate quantitative changes in mammographic breast density from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this study is the change in mammographic breast density between baseline and month 24 for each group.
The purpose of this study is to evaluate how well women may adopt a Contrast-enhanced Spectral Mammography (CESM) as their yearly breast screening test compared to the standard 2-D or 3-D mammogram.
A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to placebo for reducing breast tissue density in women identified as having dense breast tissue upon analysis of screening mammography. The Primary Study Endpoint being the percent reduction of mammographic breast tissue density on a follow-up mammogram compared to the baseline mammogram after 52 weeks of treatment.
RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density. PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high level of breast density.
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D effects mammographic breast density, mammographic texture features, and gene expression profiles in breast biopsy tissue.
Combined estrogen and progestin therapy has been shown to increase mammographic density and incidence of breast cancer in randomized trials. The investigators propose to examine the effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast density, rates of abnormal mammogram, and circulating estrogens in the ongoing, already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical trial with a primary goal of examining the effects of low-dose transdermal versus oral estrogen combined with cyclic micronized progesterone on progression of subclinical atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short duration and small size. By determining the effects of low-dose hormone therapy on the breast, the proposed ancillary study will add important information about the estimated balance of risks and benefits associated with low-dose HT and will help guide future research trials.
There is laboratory evidence that cholesterol lowering medications (statins) inhibit the growth of breast cancer cells. Clinical studies are controversial but some show that women taking statins are less likely to get breast cancer. This ongoing randomized trial compares one-year of atorvastatin (Lipitor™) or placebo for lowering mammography-defined breast density and other surrogate markers associated with breast cancer risk.
Mammographic density is sensitive to estorgen exposure and constitutes a strong intermediate maker of breast cancer risk. We hypothesize that women with higher serum xenoestrogen levels will have greater mammographic density.
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.
High mammographic density (HMD) is the strongest risk factor for non-familial breast cancer apart from age and gender. Studies of sisters and twins suggest that approximately 67% of the variation in density is attributable to common genetic factors. However, to date, efforts to identify genetic determinants of HMD have achieved limited success. We and others (Boyd et al Lancet Oncol 2009) postulate that this lack of progress in identifying genetic determinants of density is related to a failure to study younger women and misclassification of density. As women age, their breast tissues undergo atrophy, which is manifested radiologically as a decrease in mammographic density, resulting in a convergence of density values and a masking of inter-person variation. This protocol is intended to demonstrate the feasibility of methods that we plan to use in a full-scale analysis of mammographic density among women under age 50 years who receive care at the University of Vermont, Fletcher Allen Health Care (FAHC) and have been followed through the Vermont Breast Cancer Surveillance System (VBCSS). The Hormonal and Reproductive Epidemiology Branch (HREB) is currently conducting a cross-sectional study entitled, Breast Radiology Evaluation and Study of Tissues (BREAST) Stamp Project which aims to understand why mammographically dense tissues are related to elevated breast cancer risk. This project is being conducted within the VBCSS using breast cancer awareness Stamp Act funds. The BREAST Stamp project has focused on women between the ages of 40-65 years who were referred for radiologically-guided biopsy to evaluate an abnormality identified on a screening mammogram. The study has successfully enrolled over 400 women with collection of questionnaires, buccal and blood samples, and tissues. The study will continue recruiting through May 2010, with a targeted enrollment of 450-500 women. Through the infrastructure developed for the BREAST Stamp Project, mammographic volumetric density data, assessed using a novel method with density phantoms developed at UCSF, has been collected on approximately 25,000 screened women of all ages from February 2008-present. The current protocol describes a study in which we propose to capitalize on infrastructure that has been established through the BREAST Stamp Project. We propose to perform this study in two phases: Phase one will be a feasibility study: specifically, we propose to demonstrate that we can use a mailing to collect Oragene tube format saliva collection kits as a source of germline DNA and a short self-administered questionnaire. This collection of specimens and data will be used to inform the launch of phase two, the full-scale study to identify determinants of mammographic volumetric density among approximately 10,000 women less than 50 years of age for whom raw images and density data are already collected. During the first phase we hope to demonstrate feasibility by achieving at least 60% participation with unbiased representation of subjects with regard to demographics and volumetric density measurements. Once feasibility of this approach is established, we propose to launch the full-scale study by contacting the remaining (approximately 10,000) women with existing volumetric density data to collect questionnaires and DNA samples necessary to delineate the genetic determinants of mammographic density, as well as to investigate hypothesized risk factors for mammographic density and breast cancer risk, such as alcohol intake, cigarette smoking, and breastfeeding history.
Background: * Research suggests that breast cancers may arise from a population of stem cells in the normal mammary gland that produce clones of cancer cells. * Researchers are now trying to determine what events may initiate the formation of cancer cells. Objectives: * To look for and describe breast stem cells from normal breast tissue from women who do not have breast cancer. * To compare the breast stem cells between women at increased risk for breast cancer and women at average risk for breast cancer. * To show a relationship between the number and type of breast stem cells with the density (appearance) of the mammogram (breast x-ray). * To make cell cultures (grow cells under controlled conditions) from the breast stem cells. Eligibility: -Women 18 years of age and older who are at average or increased risk for breast cancer. Design: Participants complete a health history questionnaire, family history questionnaire and risk assessment questionnaire. * Participants have a mammogram and breast biopsy (surgical removal of a sample of breast tissue). * Women who can become pregnant have a urine pregnancy test....
RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.
Background: Women whose mammograms show a lot of dense areas are more likely to develop breast cancer and to have cancers that are missed by mammograms. It is unclear why some factors lead to having dense breasts and why having dense breasts increases the risk of developing breast cancer. Objectives: To determine why some women s breasts look dense on mammograms. To determine what types of cells and tissues make up dense areas of breasts and why these tissues may be more likely to become cancerous. Eligibility: Women between 40 and 65 years of age who have not had breast cancer or received medicines or radiation for any type of cancer and who are scheduled to undergo a breast biopsy. Design: This study is conducted at the University of Vermont, in collaboration with the NCI. Participants undergo the following: * Review of their medical records collected over the last 2 years by the Vermont Mammography Registry. * Participation in a short telephone interview. * Height and weight measurement. * Testing of biopsy tissue collected for diagnosis or treatment. * Future contacts regarding health status for up to 10 years, including review of additional mammograms, removed tissues, questionnaires and medical records collected by the Vermont Mammography Registry during the 10-year study. Participants may also undergo the following optional procedures: * Provide a mouthwash sample for genetic testing. * Provide a blood sample to test for markers of dense mammograms or breast cancer.
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
The primary goal of this 5-year study is to determine whether exemestane alone or in combination with celecoxib decreases breast tissue density in healthy postmenopausal women at high risk for breast cancer. Dense breast tissue seen on mammography has been linked to an increased risk of breast cancer. The study will also examine the effects of exemestane and celecoxib on bone density, blood hormone levels and quality of life. Exemestane, approved by the Food and Drug Administration for treating postmenopausal women with breast cancer, lowers the amount of estrogen in the body. Celecoxib, approved for treating arthritis pain and for reducing the number or colon polyps in an inherited syndrome, is an anti-inflammatory drug. Half of the women in the study will receive exemestane alone and half will receive exemestane and celecoxib together. In December 2004, the arm using exemestane and celecoxib was closed to accrual Postmenopausal women who are at increased risk for developing invasive breast cancer may be eligible to participate. Candidates are screened with breast cancer risk assessment, medical history and physical examination, blood tests, review of medical records, if needed, breast biopsy, and dual energy x-ray absorptiometry (DEXA) scan to assess bone density. For the DEXA scan, the subject lies still on a table for about 30 minutes while the spine and hip are scanned using a small amount of radiation. Participants take exemestane in pill form once a day for 2 years. They also take calcium and vitamin D pills daily to help protect bone health. They are followed in the clinic during the course of the study to determine the amount of drug taken and any side effects, and for the following tests and procedures: * Medical evaluation and blood tests at after 1 and 3 months on study drugs * Medical evaluation at 6 months * Breast biopsy at screening and then at 12 months * dual-emission x-ray absorptiometry (DEXA) scan of the spine, mammogram and routine blood tests before starting study drugs and then yearly for 5 years.