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BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation (BRCA-P)
Rochester, Minn.
The purpose of this trial is to compare denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.
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GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance: A Study to Determine if a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women (GENRE 2) (GENRE2)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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Screening Contrast Enhanced Digital Mammogram (CEDM) in Study Participants at Intermediate Breast Cancer Risk and Polygenic Risk Score (PRS) Results
Rochester, Minn.
The purpose of this study is to evaluate a low-cost Contrast Enhanced Digital Mammogram (CEDM) protocol as a supplemental screening method to standard mammographic screening in women at intermediate lifetime-risk (and not undergoing annual MR surveillance) for breast cancer.
Closed for Enrollment
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A Randomized Trial Evaluating Mindfulness-Based Intervention Assessing a Wearable Wellness Brain Sensing Device in Newly Diagnosed Breast Cancer Patients Undergoing Surgery
Rochester, Minn.
The purpose of this study is to determine the usefulness and effectiveness of Muse, a brain sensing headband intervention, to affect quality of life, stress, fatigue and sleep in newly diagnosed breast cancer patients who are undergoing surgical treatment.
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AFT-25, Comparing an Operation to Monitoring, with and without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial (COMET)
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.
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Assessing Biomarkers of Breast Cancer Risk In Underserved Women in Olmsted County
Rochester, Minn.
This research study is being done to determine if a low vitamin D level and mammographic density may be risk factors for developing breast cancer.
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Assessing Vitamin D and Mammographic Breast Density in a Population of Alaskan Native Women
Rochester, Minn.
This research study is being done to determine if there is an association between vitamin D level and mammographic breast density.
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Counseling and Uptake of Low Dose Tamoxifen by Patients at High Risk for Breast Cancer
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to determine if counseling patients about low dose tamoxifen will influence the decision to take (or not take) preventive therapy among women at increased risk for breast cancer.
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Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake: A Pilot Study to Determine if a Polygenic Risk Score Influences the Decision to Accept Breast Cancer Preventive Medications (Tamoxifen, Raloxifene, or Exemestane) Amongst Non-BRCA Women at Risk (GENRE)
Rochester, Minn.
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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Low-dose Tamoxifen For Radiation - Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial (LDTam)
Rochester, Minn.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells
This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
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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
Rochester, Minn.
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. Note: The standard drug used for the "breast cancer prevention" is tamoxifen. If the patient is eligible to take tamoxifen, he/she must be offered tamoxifen prevention as part of clinical care. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen. Metformin is not approved for preventing breast cancer, but is currently being tested to determine if it can prevent breast cancer.
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