Prevention Clinical Trials for Breast Cancer

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
Location: 50 locations

This randomized clinical trial studies understanding and predicting breast cancer events after treatment in patients with stage I-III breast cancer. Understanding and predicting events after cancer treatment may help to establish guidelines for reducing exercise intolerance, fatigue, cardiovascular events, and improving overall survival for patients treated for stage I-III breast cancer.
Location: 53 locations

This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.
Location: 15 locations

This phase III trial studies how well metformin hydrochloride works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.
Location: 14 locations

This phase II trial studies how well hydroxychloroquine works in preventing infection with the COVID-19 virus in patients receiving radiation therapy. Hydroxychloroquine has been approved for the prevention and treatment of malaria, and the treatment of lupus and rheumatoid arthritis. Receiving radiation therapy may increase the risk of infection with the COVID-19 virus because the patients are in frequent and close contact with healthcare workers and with other patients who may have become infected. Patients receiving treatment for cancer may also have weakened immune system. Giving hydroxychloroquine may help prevent infection with SARS-CoV-2 in patients who are receiving radiation therapy for their cancer.
Location: 7 locations

This phase II trial studies how well ruxolitinib before surgery works in preventing breast cancer in patients with high risk and precancerous breast conditions. Ruxolitinib may changes the breast cell when administered to participants with precancerous breast conditions. Ruxolitinib may stop the growth of cells by blocking some of the enzymes needed for cell growth.
Location: 7 locations

This randomized phase II trial studies how well crofelemer works in preventing diarrhea in patients with Her2 positive breast cancer who are receiving trastuzumab, pertuzumab, and docetaxel or paclitaxel with or without carboplatin. Crofelemer may prevent the movement of chloride in the gut so as to prevent diarrhea.
Location: 4 locations

This trial studies an intelligent tutoring system intervention in enhancing genetic risk assessment in underserved Blacks and Latinas at risk of hereditary breast cancer. The intelligent tutoring system intervention (BRCA-gist) is a web-based tutoring system that provides education about hereditary breast and ovarian cancer. BRCA-gist may enhance the knowledge and use of genetic cancer risk assessments in at-risk Latina and Black women.
Location: 4 locations

This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by paclitaxel.
Location: 3 locations

This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent’s Riverside. This may help doctors better understand and / or treat others who have genetic mutations.
Location: 2 locations

This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.
Location: 4 locations

This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.
Location: M D Anderson Cancer Center, Houston, Texas

This trial studies how well weight management and health behavior intervention works in helping patients with hereditary breast and ovarian cancer and Lynch syndrome mutation carriers lose or maintain a healthy weight and lower their risk for cancer. Lifestyle behaviors such as physical activity, diet, and weight management may play a key role in preventing cancers and improving outcomes even in those with hereditary cancer syndromes.
Location: M D Anderson Cancer Center, Houston, Texas

This phase II trial studies whether memantine, a medication commonly used for dementia, may lessen chemotherapy-related cognitive changes, also known as ''chemobrain,'' experienced by some patients receiving treatment for breast cancer. Cancer-related cognitive change refers to memory and concentration problems that can occur with cancer and cancer treatments. Memantine blocks the uptake of calcium by certain brain cells and decreases abnormal activity in the brain. Giving memantine may prevent chemotherapy-related cognitive decline, improve quality of life, physical function, and mental health in patients with breast cancer.
Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

This trial investigates the impact of an educational video compared to a fact sheet in enhancing the use of genetic counseling and testing for Latina women at-risk hereditary breast and ovarian cancer. Having a change or alteration (genetic mutation) in certain genes can increase the risk of developing breast and ovarian cancer. Latina women are less likely than non-Latina Whites to use genetic counseling and testing. Participating in genetic counseling and testing can inform important treatment and prevention decisions for individuals at risk of hereditary breast and ovarian cancer.
Location: 5 locations

This trial studies the side effects of robot-assisted nipple sparing mastectomy (RNSM) using the da Vinci surgical system. Nipple sparing mastectomy (NSM) preserves the skin and nipple areola complex for improved body image and patient satisfaction, but it is technically demanding and has inconsistent outcomes. RNSM is minimally invasive and has the potential to improve the safety and effectiveness of NSM. This may increase patient eligibility for nipple sparing mastectomy while optimizing its surgical and oncologic safety and patient reported outcomes.
Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

This clinical trial aims to further understand hair care product use and knowledge among women of color. Phthalates are a common ingredient in hair care products and is a well-known endocrine disrupting chemical. Endocrine disrupting chemicals from the surrounding environment may influence the risk of breast cancer; especially when women are exposed to endocrine disrupting chemicals while their breast tissue is changing (such as during pregnancy and postpartum). Learning about the different chemicals in hair care products may help participants make informed decisions about which hair care products they use.
Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

Mechanistic data show that compounds in fruits and vegetables have anti-inflammatory and anti-carcinogenic properties that can reduce breast cancer risk. However, observational and interventional studies have provided mixed results, and a recent report by the American Institute for Cancer Research (AICR) concludes that the data are insufficient but suggestive that non-starchy vegetables and foods containing carotenoids reduce risk. Measurement error, relatively low levels of carotenoid-rich fruit and vegetable intake in the study populations, emphasis on diet in later adulthood, and confounding factors likely contribute to the weak associations. Therefore, the investigators will conduct a randomized diet intervention trial in young women to assess the extent to which at least 8 to 10 daily servings of deeply pigmented and nutrient dense fruits and vegetables reduces biomarkers of breast cancer risk. The intervention is focused on breastfeeding women because: 1) pregnancy and lactation are normal early life course events; 2) the risk of pregnancy-associated breast cancer (PABC) is increased for up to 10 years postpartum; 3) a dietary intervention to reverse the detrimental molecular changes associated with puberty and pregnancy is more likely to be successful in younger than in older women;4) a diet rich in fruits and vegetables is hypothesized to reduce the inflammation during lactation / weaning and lower PABC risk; 5) postpartum lactating women may be a highly motivated population; and 6) breastmilk provides access to the breast microenvironment and breast epithelial cells to non-invasively assess the diet intervention directly in the breast. Four hundred nursing mothers will be randomly assigned to either the intervention arm, in which they are asked to increase fruit and vegetable intake to at least 8 to 10 daily servings for one year, or to a control condition in which participants receive a dietary guideline for breastfeeding mothers. Women in the intervention arm will receive counseling and boxes of fruits and vegetables for the first 20 weeks, after which they will continue to receive counseling. Changes in DNA methylation and cytokine profiles in breastmilk will be evaluated. Maternal weight and body fat distribution, and infant growth will be monitored. These results will greatly expand our knowledge of how diet alters molecular pathways in a specific organ, ultimately contributing to both breast cancer etiology and prevention.
Location: University of Massachusetts, Amherst, Amherst, Massachusetts

This phase II trial studies how well a telephone genetic counseling intervention works in enhancing genetic cancer risk assessment in Latinas at risk of hereditary breast and ovarian cancer. Genetic counseling may help providers and patients make decisions for cancer prevention or cancer treatment. Adapting a telephone genetic counseling intervention in Spanish for Latinas who are at risk of hereditary breast and ovarian cancer may enhance their use of genetic counseling services.
Location: MedStar Georgetown University Hospital, Washington, District of Columbia

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
Location: M D Anderson Cancer Center, Houston, Texas

This study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in Nipple Sparing Mastectomy procedures.
Location: M D Anderson Cancer Center, Houston, Texas

This trial studies how well acute exercise intervention works in reducing the risk of breast cancer in healthy participants. Acute exercise intervention may affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer.
Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.
Location: M D Anderson Cancer Center, Houston, Texas

This phase II trial studies how well sirolimus works in preventing invasive breast cancer in patients with breast cancer confined to the mammary ducts or lobules of the breast. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

This is a pilot study evaluating the effect of hydroxytyrosol, a component of olive oil, on mammographic density in women at high risk of developing breast cancer.
Location: See Clinical Trials.gov