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Preventing Breast Cancer

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

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Tamoxifen to Reduce Breast Cancer Risk in Hodgkin's Survivors

Low-dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial (NCT01196936)

Summary

Chest radiation is virtually always used to treat Hodgkin lymphoma because it significantly increases survival. But radiation therapy also increases a Hodgkin's survivor's risk of developing breast cancer. Studies show that a woman who has received radiation to treat Hodgkin lymphoma has a breast cancer risk comparable to that of a woman who carries a BRCA mutation. Tamoxifen (Nolvadex®) is FDA-approved for breast cancer risk reduction in high-risk women. But the standard dose of tamoxifen often causes side effects, making some women hesitant to use it. Recent studies suggest that a lower dose may be as effective and result in fewer side effects. The goal of this trial is to determine whether a low dose of tamoxifen will be effective in reducing breast cancer risk in women who were treated for Hodgkin lymphoma as a child or young adult.
This is a Phase II trial

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Effect of Diet & Exercise Before Surgery In Overweight Postmenopausal Women with DCIS

Exploring Effects of Weight Loss on Ductal Carcinoma In Situ (NCT02224807)

Summary

Ductal carcinoma in situ (DCIS) is a stage 0, pre-cancer. Women with DCIS are at increased risk for developing breast cancer. Because it is not yet known which DCIS will progress on to breast cancer and which will not, currently most women are treated for DCIS with surgery and often radiation or hormone therapy. Post-menopausal women who are overweight are at increased risk for invasive breast cancer. Animal studies suggest that very low calorie diets may slow cancer growth. Calorie restriction in women with DCIS may reduce their risk of developing invasive breast cancer. This study is looking at the effect that diet and exercise have on biomarkers found in breast tissue and blood that provide information about cancer progression, hormonal status, inflammation, tumor proliferation and cell death. To be eligible, a woman must be overweight or obese (BMI: 25-39.9), postmenopausal and scheduled to have a lumpectomy or mastectomy for DCIS in three weeks or more.

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Exercise During Treatment for DCIS and Early-Stage Disease

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory (NCT01157130)

Summary

Studies suggest that exercise may reduce the risk of a breast cancer recurrence as well as improve quality of life. Precisely how exercise reduces recurrence risk is not fully understood. However, scientists think that exercise during breast cancer treatment may affect proteins and hormones, such as insulin and estrogen, that are related to cancer growth. The goal of this trial is to determine the effect that exercise instruction has on exercise levels, biological measures, and psychosocial factors. To be eligible, participants must have been recently diagnosed with DCIS or early-stage breast cancer and not yet begun treatment. In addition, participants must be planning to receive treatment that includes chemotherapy and/or radiation.

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hCG for Breast Cancer Prevention in Women Taking Tamoxifen

Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women (NCT00808522)

Summary

Women who have been pregnant have a decreased risk of developing breast cancer. Researchers have been evaluating different hormones and practices associated with pregnancy to determine why pregnancy lowers breast cancer risk. One of the hormones investigators are studying is human chorionic gonadotropin (hCG), which is produced by the developing embryo during pregnancy. The goal of this trial is to determine if giving hCG along with tamoxifen (Nolvadex®) might further decrease a woman's risk of a recurrence or a new cancer. This will be determined by evaluating whether hCG results in a decrease in breast density, a characteristic that is associated with increased breast cancer risk. To be eligible for this trial, women must be taking tamoxifen (Nolvadex®) for the treatment or prevention of breast cancer.
This is a Phase III trial

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Telapristone Before Mastectomy for High-Risk, DCIS or Stage I-II Breast Cancer

Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy (NCT02314156)

Summary

Telapristone is an anti-progesterone drug. Laboratory studies have found telapristone can prevent tumors from growing. Telapristone can be given as a pill or absorbed into the skin through a patch. Researchers want to see if giving telapristone before surgery can help prevent breast cancer in premenopausal women. This study is comparing the effectiveness of a telapristone pill or patch to a placebo pill or patch for preventing breast cancer in high-risk women and reducing risk of recurrence in women with DCIS or stage I-II breast cancer. To be eligible, a woman must be premenopausal and scheduled to have a unilateral or bilateral mastectomy.
This is a Phase II trial

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

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Effect of Tumeric on Breast Tissue in Obese, High-Risk Women

Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial (NCT01975363)

Summary

Laboratory studies suggest that tumeric (curcumin) may have anti-cancer effects. This may be because tumeric can reduce inflammation, which has been linked to cancer growth. Researchers think that tumeric may reduce inflammation in fat tissue and breast tissue, which may decrease breast cancer risk. This pilot study is looking at the effect that tumeric has on the breast tissue of obese women who are at high risk for breast cancer.

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Reducing the Risk of Breast Cancer with Omega-3 Fatty Acids and Weight Loss

Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention (NCT02101970)

Summary

Studies have found that women who are overweight are at increased risk for developing breast cancer. This may be because obesity is linked to chronic inflammation in breast tissue, which has been shown to increase breast cancer risk. Omega-3 fatty acids cannot be made by the body and must be obtained from food or supplements. Studies suggest that omega-3 fatty acids have the ability to resolve chronic inflammation. This study is investigating whether adding a high dose of omega-3 fatty acids to a weight loss program reduces inflammation in the breast in women who are at high risk for developing breast cancer.
This is a Phase II trial

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Metformin for Risk Reduction in High-Risk, Overweight Women

A Double Blind Prospective Study of Metformin vs. Placebo in Overweight or Obese Post-menopausal Women at Elevated Risk for Breast Cancer (NCT01793948)

Summary

Researchers are studying ways to prevent breast cancer from occurring in high-risk women. Observational studies suggest that metformin, a drug commonly used to treat type 2 diabetes, might also reduce breast cancer risk. This study is investigating whether metformin is more effective than a placebo in reducing breast cancer risk in high-risk postmenopausal women who are also overweight or obese. To be eligible, a woman must have a body mass index (BMI) >= 25 and be considered high risk due to a strong family history of breast cancer or a previous breast biopsy that showed atypical hyperplasia.

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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.

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Tetrathiomolybdate (TM) for Stage II, III, and IV Breast Cancer

A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence (NCT00195091)

Summary

Scientists are trying to develop new treatments for preventing recurrence of primary breast cancer or progression of advanced disease. Studies have shown that tumors need copper to grow new blood vessels, a process called angiogenesis. Tetrathiomolybdate (TM) is a drug that is currently being studied in clinical trials that is able to decrease copper levels in the body. This, in turn, may keep tumors from growing and spreading. The purpose of this trial is to assess the safety and effectiveness of TM in women with Stage II, III, or IV breast cancer. Note: Participants who are stage IV must have no evidence of disease.
This is a Phase II trial

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The Effect of a Time Restricted Diet on Weight Control, Hormones and Breast Tissue

A Pilot Study of Time Restricted Diet in Obese/Overweight Pre &Amp; Postmenopausal Women (NCT02154984)

Summary

Women who are overweight are at increased risk of developing breast cancer. A time-restricted diet is a type of diet that requires people to restrict their daily eating to a specific time frame each day. This study is looking at whether a time-restricted diet is easy for women to maintain and what effect it has on weight, hormones and breast tissue. To be eligible, a woman must have a stable weight and have a body-mass index (BMI) of 25-40.

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Exercise Programs in Healthy, High-Risk Young Women

Exercise Programs in Healthy Young Women at Increased Risk of Developing Breast Cancer (NCT00892515)

Summary

Studies suggest that exercise may decrease a woman's risk of developing breast cancer. It is not yet known whether certain types of exercise are more likely to reduce risk than others, or whether low-intensity exercise and high-intensity exercise have the same effects. The goal of this trial is to compare the effects of a low-intensity and high-intensity exercise program on hormone levels, breast density, and body composition in healthy women between the ages of 18 and 35 who are at increased risk of developing breast cancer.

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Prevention Education For African American Women

Disseminating Breast Cancer Prevention to African American Women (NCT01299623)

Summary

African American women are more likely to have breast cancer that is more aggressive, and diagnosed at an earlier age compared to other ethnic and racial groups. Older African-American women are less likely to be diagnosed with breast cancer, but they are more likely to be diagnosed with an aggressive, later stage tumor. Researchers are trying to develop effective breast cancer education programs for African-American women. This study will evaluate a breast cancer prevention education program that is culturally tailored to African-American women. To be eligible, participants must be a resident of the Philadelphia metropolitan area.

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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

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Studying Breast Milk & Cancer Risk in African-American Women

Epigenetics and Breast Cancer Risk in African American Women (NCT01736306)

Summary

Pregnancy and breastfeeding are believed to influence breast cancer risk. Studying cells found in breast milk may provide clues to the genetic changes that increase breast cancer risk. To date, most of the breast milk studied has been collected from white women. Collecting and analyzing breast milk samples from African-American women, and following these women to see who goes on to develop breast cancer, could help researchers learn more about breast cancer risk. To be eligible, participants must identify as African-American, Black, or African; be currently nursing a baby; and have had or be scheduled to have a breast biopsy. (Women who do not identify as African-American, Black or African can participate in another ongoing Breast Milk Study at the University of Massachusetts.)

  • Participation TimeVia U.S. Mail
  • No Visits Required for this TrialNo travel required 
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Multiplex Genetic Testing for Evaluation of Breast Cancer Risk

Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study (NCT02514499)

Summary

Multiplex genetic testing can look for many different gene mutations, rather than just one or two. Researchers are evaluating the short- and long-term benefits and risks of multiplex testing in individuals who are at high risk for developing breast cancer and BRCA1/2 negative. This study will investigate what factors affect an individual's decision to receive genetic test results and what factors affect outcomes after the participants receive their results. The researchers will use their findings to determine the best way to provide support to individuals undergoing multiplex testing.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793