Prevention Clinical Trials for Breast Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for breast cancer prevention. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 25
  • Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection

    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

  • Understanding and Predicting Breast Cancer Events after Treatment in Patients with Stage I-III Breast Cancer

    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

  • Metformin Hydrochloride in Preventing Breast Cancer in Patients with Atypical Hyperplasia or In Situ Breast Cancer

    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

  • A Study of Hydroxychloroquine versus Placebo to Prevent COVID-19 Infection in Patients Receiving Radiation Therapy

    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

  • Aerobic Exercise in Changing Biomarkers in Patients with Solid Tumors or Clonal Hematopoiesis

    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

  • 4-hydroxytamoxifen Topical Gel in Reducing the Risk of Breast Cancer in Women with Mammographically Dense Breast

    This randomized phase II trial studies whether putting afimoxifene (4-hydroxytamoxifen topical gel) on the breast skin lowers mammographic density compared with putting placebo gel on the breast skin. Women with dense breast tissue have a higher risk for developing breast cancer. 4-hydroxytamoxifen topical gel applied to the breast skin may allow the drug to get into the breast and lower risk of breast cancer with fewer unwanted effects than oral tamoxifen.
    Location: 7 locations

  • Ruxolitinib in Preventing Breast Cancer in Patients with High Risk and Precancerous Breast Lesions

    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

  • Crofelemer in Preventing Diarrhea in Patients with Her2 Positive Breast Cancer Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel with or without Carboplatin

    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

  • Intelligent Tutoring System Intervention in Enhancing Genetic Risk Assessment in Underserved Blacks and Latinas at Risk of Hereditary Breast Cancer

    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

  • Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients with Breast Cancer

    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: 2 locations

  • Pro-Active Genetic Testing in Patients with Solid Tumors, Inherit Study

    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

  • Retinoid 9cUAB30 in Producing a Biologic Effect in Patients with Early Stage Breast Cancer

    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

  • Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women

    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

  • Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

    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

  • Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

    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

  • Telephone Genetic Counseling Intervention in Enhancing Genetic Cancer Risk Assessment in Latinas at Risk of Hereditary Breast and Ovarian Cancer

    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

  • Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants

    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

  • Comprehensive Lifestyle Change in Preventing Patients from Breast Cancer

    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

  • Cancer Education and Empowerment for Preventing and Controlling Cancer in Breast or Ovarian Cancer Survivors, The Grace Study

    This trial studies cancer education and empowerment for preventing and controlling cancer in breast and ovarian cancer survivors and their families. Cancer education strategies, such as targeted generic print and tailored telephone counseling, may help survivors learn more about the risks for hereditary and ovarian breast cancer, as well as learning about current screening guidelines or other cancer prevention measures.
    Location: Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

  • Sirolimus in Preventing Invasive Breast Cancer in Patients with Ductal Carcinoma In Situ, Lobular Carcinoma In Situ, Atypical Lobular Hyperplasia, or Atypical Ductal Hyperplasia

    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

  • Olive Oil for High Risk Breast Cancer Prevention in Women

    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

  • Tamoxifen Citrate or Afimoxifene in Treating Patients with Estrogen Receptor Positive Breast Cancer

    This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
    Location: 7 locations

  • Making Informed Choices on Incorporating Chemoprevention into Care (MiCHOICE)

    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: See Clinical

  • Alendronate Sodium in Preventing Breast Cancer in Premenopausal Patients Undergoing Risk-Reduction Surgery

    This pilot phase I clinical trial studies how well alendronate sodium works in preventing breast cancer in premenopausal patients that have high risk gene mutations and are undergoing surgery to reduce the risk of breast cancer or are undergoing routine surveillance or are willing to undergo two clinic biopsies. Alendronate sodium may increase the number and activity of special immune cells that are able to kill new tumor cells in breast tissue.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer

    This phase I trial studies the side effects and best dose of bexarotene in preventing breast cancer in patients at high risk for breast cancer.
    Location: See Clinical