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Preventing Breast Cancer

A Sleep Intervention for Women Who are at High Risk of Breast Cancer

A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer (NCT02613923)

Summary

To take part in this study, you must be at high risk of developing breast cancer. You must also sleep 6 hours or less per night, have access to the internet, and have an email address. This study is investigating whether the GO! to Sleep Program helps improve the sleep duration and sleep quality of women at high risk of developing breast cancer. The GO! to Sleep Program is an interactive, online program, designed for people who are experiencing short term insomnia.

Effect of Olive Oil on Breast Density in High-Risk Women

A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer (NCT02068092)

Summary

Studies have shown that women with dense breast tissue are at increased risk for developing breast cancer. Laboratory studies have found that hydroxytyrosol--a major component of olive oil--is a powerful antioxidant with very low toxicity in the human body, even at high doses. Researchers think that hydroxytyrosol may reduce dense breast tissue. This study will evaluate the effect that hydroxytyrosol has on the breast tissue of women who are at high risk for developing breast cancer.


This is a Phase II-III trial

Metformin to Reduce Breast Cancer Risk in Women with Atypical Hyperplasia, DCIS or LCIS

Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology After 12 Months Metformin (1,1-Dimethylbiguanide Hydrochloride) Chemoprevention Versus Placebo Control in Premenopausal Women (NCT01905046)

Summary

Women who have been diagnosed with atypical hyperplasia, DCIS or LCIS are at increased risk of developing breast cancer. Researchers are trying to find drugs (chemoprevention) that can reduce this risk. Findings from previous studies suggest that metformin, a drug used to treat diabetes, can reduce breast cancer risk in high-risk women. This study is looking at whether metformin is better than a placebo at reducing breast cancer risk in women with atypical hyperplasia, DCIS or LCIS. To be eligible, a woman must have had a digital mammogram within the previous 180 days and have a BMI ≥25 (overweight).


This is a Phase III trial

Metformin For Reducing Breast Cancer Risk in Overweight Premenopausal Women

Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk (NCT02028221)

Summary

Women who are overweight are at greater risk of developing breast cancer after menopause. Doctors think this may be because being overweight is linked to a metabolic syndrome that increases hormone levels and inflammation. Previous research findings suggest that metformin, a drug commonly used to treat type 2 diabetes, may reduce breast cancer risk. This study is looking at whether metformin is more effective than a placebo at reducing breast cancer risk in overweight premenopausal women who have a BMI ≥25.


This is a Phase II trial

Using Breast Duct Cells to Assess Cancer Risk

Characterization of High Risk Breast Duct Epithelium by Cytology, Breast Duct Endoscopy, and cDNA Gene Expression Profile (NCT00028340)

Summary

Most breast cancers begin in the cells that line the milk ducts in the breast. Previous studies have identified certain changes in the ductal cells and breast tissue that are associated with an increased risk of developing breast cancer. Ductal lavage and ductal endoscopy are techniques that allow researchers to study the cells and fluid that line the breast duct. In this study, researchers will use ductal lavage and ductal endoscopy to compare the ductal cells and tissue of women who are at high risk for breast cancer, breast cancer survivors and healthy volunteers.

Effect of Vitamin D on Breast Cells in Women With DCIS or LCIS

An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS (NCT02936999)

Summary

DCIS is a non-invasive breast cancer. Non-invasive means it has not spread out of the milk duct into the breast tissue. LCIS is an area of abnormal cell growth. Having DCIS or LCIS increases your risk for developing breast cancer. In this study, researchers will have women with LCIS or DCIS take vitamin D before surgery. The researchers will then study the tissue removed during surgery to see the effect the vitamin D has had on the breast cells.

Breast Cancer Risk Assessment in Women Aged 40-49 in Boston, Massachusetts

Breast Cancer Risk Assessment in Women Aged 40-49 (NCT03180086)

Summary

To take part in this study, you must be age 40 to 49 and be scheduled for a routine visit at HealthCare Associates, Beth Israel Deaconess Medical Center, in Boston, Massachusetts, in 4 to 12 weeks. This study is evaluating a personalized risk-based approach for mammography screening and breast cancer risk reduction for women age 40-49. Women who take part in this study will receive personalized information about their risk of developing breast cancer in the next 5 years. They will also receive information about mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing.

Web-based Decision Aids for High-Risk Women

Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial (NCT03069742)

Summary

To take part in this study, you must be at high risk for breast cancer. You must also have a primary care provider at Columbia University Medical Center/ New York-Presbyterian Hospital. This study is evaluating how well the newly developed RealRisks decision aid works to help you understand your breast cancer risk and your risk reduction options and to develop an action plan with your provider. RealRisks is a web-based decision aid for patients that is designed to work with the Breast Cancer Risk Navigation tool developed for doctors.

Fosamax Before Preventive Mastectomy in High-Risk Women or Women with DCIS

Pilot Clinical Trial of Short-Term Bisphosphonate Administration as Chemoprevention for Breast Cancer Via Engagement of γδ T Cells (NCT02781805)

Summary

To take part in this study, you must be scheduled to have a preventive (prophylactic) mastectomy of one or both breasts because you are at high risk for developing breast cancer or because you have been diagnosed with ductal carcinoma in situ (DCIS). You must also be premenopausal (still have your period). Alendronate (Fosamax) is a drug used to help maintain bone strength. Studies suggest this drug may also have an effect on breast tissue and cancer cells. Giving a drug before surgery allows researchers to study the effect it has on breast tissue. If you take part in this study, you will take Fosamax before you have your mastectomy.


This is a Phase I trial