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: 70 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: 65 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: 35 locations

This trial studies the effect of aerobic exercise in changing biomarkers in patients with solid tumors or clonal hematopoiesis, a condition in which some of the patients' blood cells have a different genetic pattern than the rest of the blood cells. Aerobic exercise stimulates and strengthens the heart and lungs, and improves the body’s use of oxygen. This may help prevent or slow the growth of tumors by changing the biomarkers (signs of disease) found in the blood or by preventing recurrence of certain cancers.
Location: 7 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 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 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 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 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: 3 locations

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: 2 locations

This clinical trial studies the effect of an exercise intervention in preventing obesity and improving movement in stage I-III breast cancer survivors. A 16-week exercise program may help to decrease inflammation in the fat tissue.
Location: 2 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 study evaluates the safety and effectiveness of the da Vinci Xi Surgical System in Nipple Sparing Mastectomy procedures.
Location: 2 locations

This phase I / II trial studies the effect of apixaban or enoxaparin in preventing blood clot in patients undergoing breast reconstruction. Apixaban and enoxaparin are anticoagulant drugs that prevent blood clot. Giving apixaban or enoxaparin after breast reconstruction surgery may prevent blood clot that starts in the vein.
Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

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 clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
Location: Mayo Clinic in Florida, Jacksonville, Florida

This clinical trial studies the effect of a web-based diet and exercise intervention in reducing obesity and improving the health of cancer survivors and their partners. The purpose of this trial is to learn how a web-based diet and exercise intervention affects the health behaviors of cancer survivors and the people around them, as well as how it affects body weight, overall health and ability to move, quality of life, and blood markers of successful aging.
Location: University of Alabama at Birmingham Cancer Center, Birmingham, Alabama

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 / III trial studies the effect of decreasing bacteria on the skin (bacterial decolonization) before treatment with radiation in preventing radiation dermatitis in patients with breast or head and neck cancer. Radiation dermatitis is a common rash that can occur from radiation therapy. Previous study showed that people who have bacteria in their nose prior to initiation of radiotherapy have an increased risk of developing radiation dermatitis. Bacterial decolonization may prevent high-grade radiation dermatitis and improve quality of life during radiotherapy in patients with breast or head and neck cancer.
Location: Montefiore Medical Center-Weiler Hospital, Bronx, New York

This clinical trial develops and tests a self-help smoking cessation intervention to motivate cancer patients to quit smoking. The smoking cessation intervention consist of self-help materials designed to help cancer patients understand the relevance of smoking upon their cancer, its successful treatment, and their recovery. A motivational smoking cessation intervention may increase motivation to quit smoking, and ultimately smoking cessation itself, among a wide spectrum of cancer patients.
Location: Moffitt Cancer Center, Tampa, Florida

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 Ib trial studies the side effects of INO-5401 with or without INO-9012 and tests a new way of administering vaccines (electroporation) in adult cancer and non-cancer patients with BRCA1 or BRCA2 mutations. INO-5401 contains genes which are active in human cancers (hTERT, PMSA, and WNT1) and are felt to be good targets for the immune system for both people who have had cancer or for those at increased risk of getting cancer. INO-9012 contains the gene for IL12, a part of the body’s immune system. Electroporation generates electrical pulses through an electrode placed in a tumor to enhance the ability of anticancer drugs to enter tumor cells. Giving INO-5401 and INO-9012 may increase the immune response to the vaccine.
Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

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