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Inflammatory Breast Cancer
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Inflammatory Breast Cancer
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 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
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Prevention

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

Studying Biomarkers in Healthy Women Who Are Not High Risk

Prostaglandin Inhibition to Prevent Breast Cancer (NCT01769625)

Summary

Some studies have suggested that inflammation in the body may increase breast cancer risk. Vitamin D helps the body absorb and maintain the right amount of calcium in the blood. It also helps control cell growth and reduce inflammation. Celecoxib (Celebrex®) is a drug that reduces inflammation by inhibiting an enzyme called COX-2. The purpose of this study is to determine if vitamin D alone or in combination with Celebrex decreases levels of certain biological markers (biomarkers) thought to be related to breast cell changes and breast cancer risk. This trial is enrolling healthy women with a normal risk of developing breast cancer.
This is a Phase I-II trial

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

The Effect of Vitamin D & Celebrex® on Breast Cancer Biomarkers

Breast Cancer Prevention Using Synergistic Prostaglandin Inhibitors (The Vitamin D/Celecoxib Study) (NCT01425476)

Summary

Some studies have suggested that inflammation in the body may increase breast cancer risk. Vitamin D helps the body absorb and maintain the right amount of calcium in the blood. It also helps control cell growth and reduce inflammation. Celecoxib (Celebrex®) is a drug that reduces inflammation by inhibiting an enzyme called COX-2. The purpose of this study is to determine if vitamin D alone or in combination with Celebrex decreases levels of certain biological markers (biomarkers) thought to be related to breast cell changes and breast cancer risk. To be eligible, a woman must be at an increased risk for developing breast cancer because she has been diagnosed with precancerous breast changes, has a five-year Gail Model risk score that is 1.66% or higher, or has a personal or family history of breast cancer.
This is a Phase I-II trial

Flaxseed to Reduce Risk in High-Risk Premenopausal Women

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer (NCT01276704)

Summary

Secoisolariciresinol digluscside (SDG) is a lignan (plant-based estrogen) that is found in flaxseed. Laboratory studies have shown that plant-based estrogens can fit into the estrogen receptor, where they act as weak estrogens in the breast and uterus. By blocking the estrogen receptor, plant-based estrogens may be able to protect cells from the stronger estrogens produced by a woman's body. Brevail® is a supplement that contains SDG made from flaxseed. The purpose of this study is to see whether Brevail® reduces the risk of breast cancer in high-risk premenopausal women. To be eligible, women must be high risk due to one of the following: a first or second degree relative with breast cancer diagnosed before the age of 60; a prior history of atypical hyperplasia, LCIS, or multiple prior breast biopsies regardless of histology; high mammographic density; prior or current evidence of atypia; or a known BRCA1 or 2 mutation.
This is a Phase II trial

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.

Flaxseed for Risk Reduction in High-Risk Premenopausal Women

Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer (NCT00794989)

Summary

Flaxseed is a good source of lignans, a compound that may act like a weak estrogen. Some researchers believe that eating these weak estrogens may keep your body from producing its strong estrogens, which, in turn, may reduce breast cancer risk. Other researchers believe that it may not be beneficial for women to consume any substances that act like weak estrogens. The goal of this trial is to determine the effect of flaxseed on the development of breast cancer. To be eligible, women must be at high risk of developing breast cancer because they have previously been diagnosed with stage I breast cancer or ductal carcinoma in situ (DCIS) and it has been more than one year since they have completed hormone therapy and/or chemotherapy; have been diagnosed with lobular carcinoma in situ (LCIS); ductal or lobular hyperplasia; or have a greater than 20 percent risk of developing breast cancer according to the Gail or Claus risk models.

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.

Letrozole for Postmenopausal High-Risk Women

Letrozole in Treating Healthy Postmenopausal Women at High Risk for Breast Cancer (NCT01077453)

Summary

Aromatase inhibitors, like letrozole (Femara®), are a class of drugs that block the enzyme aromatase, which is involved in the production of estrogen. Researchers believe these drugs may also be effective in reducing breast cancer risk in high-risk women. The goal of this trial is to study the side effects and the best dose of letrozole for treating healthy postmenopausal women who are at high risk for breast cancer. To be eligible, women must be postmenopausal and either have previously been diagnosed with lobular carcinoma in situ (LCIS) or have a 1.66% probability of invasive breast cancer within five years on a Breast Cancer Risk Assessment Tool. Women who have had a previous diagnosis of DCIS or invasive breast cancer are not eligible.
This is a Phase I trial

Increasing Physical Activity to Reduce Breast Cancer Risk

Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk (NCT01837147)

Summary

Studies have shown that postmenopausal women who are overweight or do not exercise are at higher risk of developing breast cancer. Teaching overweight women how to be aware of and increase their activity level may help reduce breast cancer risk. This study will compare whether a new electronic device that measures the body's movement and works alongside a website is better than a pedometer at increasing postmenopausal women's activity levels. If this technology-based system is found to be effective, it may be tested in larger studies that are looking at ways to decrease breast cancer risk.

Breast Cancer Screening Program for High-Risk Women

A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer (NCT00989638)

Summary

Combining multiple screening techniques may improve a woman's chance of having a small cancer or pre-cancer found early. The goal of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women using mammography, breast magnetic resonance imaging (MRI), and clinical breast exam. The study will also evaluate quality of life and compare MRI and mammography. This trial is open to women who are at high risk because they have one of the following: BRCA1, BRCA2, or another known mutation; a personal history of breast cancer before age 35; a personal history of DCIS before age 35 and a mother or sister with breast or ovarian cancer before age 50; are cancer survivors who had chest radiation before age 30; or are of African ancestry and have a relative who had breast cancer before age 40.

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.

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.

Vitamin D3 for High-Risk Women

High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer (NCT01097278)

Summary

Vitamin D is essential for the formation, growth, and repair of bones and for normal calcium absorption and immune function. It is obtained primarily through exposure of the skin to ultraviolet radiation in sunlight, but it can also be obtained from some foods and dietary supplements. Some studies suggest that higher intakes of vitamin D from food and/or supplements and higher levels of vitamin D in the blood are associated with reduced risks of some types of cancer. The goal of this trial is to determine whether a high dose of vitamin D3 (cholecalciferol) can change risk factors associated with breast cancer, such as breast density and a protein called Ki-67. To be eligible, participants must be at high risk of developing breast cancer because they have a past history of DCIS or LCIS, have a known genetic mutation, or have a Gail risk score >1.67%.
This is a Phase II trial

Using Family History Info to Help Determine Breast Cancer Risk

Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care (NCT01468675)

Summary

Knowing a patient's family health history can help a primary care provider determine whether that patient may be at high risk of developing breast cancer or other diseases. However, many primary care providers do not have the time to obtain a family health history or to provide individualized risk assessment during a routine office visit. This study is investigating whether adding a risk report created from a patient's answers to a web-based risk assessment questionnaire on family health history and lifestyle to a patient's medical record will help providers identify high risk patients. To be eligible for this trial, participants must have had a recent visit to a participating primary care practice.

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 

Side Effects of Ovarian Removal in Women with a BRCA Mutation

(NCT01948609)

Summary

Women who carry a BRCA1 or BRCA2 genetic mutation have a greatly increased risk of developing breast and ovarian cancer. Surgically removing the fallopian tubes and ovaries (called a risk reducing salipingo-ooporectomy or RRSO) reduces the risk of both breast and ovarian cancer because it reduces estrogen production. However, shutting down estrogen production can increase the risk of heart disease, memory problems, osteoporosis and bone fractures and result in a decline in wellbeing and sexual function. This study is comparing the health of women with a BRCA mutation who choose RRSO with women with a BRCA mutation who do not choose RRSO. To be eligible for this study, a woman must have had a genetic test that showed she has a BRCA1 or BRCA2 genetic mutation.

Using MRI to Identify New Breast Cancer Risk Factors

Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk (NCT01649661)

Summary

Researchers are studying the normal (non-cancerous, healthy) breast to try to identify new breast cancer risk factors. The purpose of this study is to learn whether a woman's health history and hormone levels influence what her breast looks like on a breast MRI. The investigators' goal is to find a way to identify which women may be at higher risk of developing breast cancer. To be eligible, participants must not have a prior history of cancer and be scheduled for a breast MRI at Memorial Sloan-Kettering Cancer Center.