Prevention Clinical Trials for Breast Neoplasm

Clinical trials are research studies that involve people. The clinical trials on this list are for breast neoplasm 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 1-24 of 24
  • Metformin Hydrochloride in Preventing Breast Cancer in Patients with Atypical Hyperplasia or In Situ Breast Cancer

    This randomized phase III trial studies metformin hydrochloride to see how well it 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: 24 locations

  • Alternative Dosing of Exemestane before Surgery in Treating Postmenopausal Patients with Stage 0-II Estrogen Positive Breast Cancer

    This randomized phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.
    Location: 3 locations

  • Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients

    This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S / GM-CSF versus trastuzumab + GM-CSF alone. Our target study population is high-risk HER2-positive breast cancer patients. High-risk HER2-positive breast cancer patients are defined as: Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR. Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo surgery as a first intervention and are found to have ≥ 4 positive lymph nodes. Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a first intervention and are found to have 1-3 positive lymph nodes. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed.
    Location: 4 locations

  • Nelipepimut-S plus GM-CSF Vaccine Therapy in Treating Patients with Breast Cancer

    This randomized phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and / or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.
    Location: 3 locations

  • Community Hospital Identification with MRI and Echocardiography in Detecting Chemotherapy-related Cardiotoxicity in Patients with Stage I-III Breast Cancer or Lymphoma

    This phase II trial studies community hospital identification with magnetic resonance imaging (MRI) and echocardiography in detecting chemotherapy-related cardiotoxicity in patients with stage I-III breast cancer or lymphoma. Diagnostic procedures, such as MRI and echocardiography, may help find and diagnose chemotherapy-related toxicity in patients. Different ways of measuring heart health will be explored to determine if there are easier and faster ways to measure how chemotherapy may negatively impact the function and size of the heart when being treated for breast cancer or lymphoma at a community hospital.
    Location: 3 locations

  • Vaccine Therapy in Preventing Cancer Recurrence in Patients with Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

    This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.
    Location: 2 locations

  • Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)

    Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS group have an L-Dex change that is ≥6.5 units higher than the pre-surgical baseline measure, and when patients in the tape measurement group have a volume change in the at-risk arm that is between ≥ 5% and <10% above pre-surgical baselines (without similar change in non-at-risk arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.
    Location: 2 locations

  • Diabetes Prevention Program with or without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants

    This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Physical Activity in Helping Lose Weight in Breast Cancer Survivors and High Risk Women

    This trial studies how well physical activity works in helping lose weight in breast cancer survivors and women who are at high risk for development of breast cancer. Modest calorie restriction with a graduated physical activity may help people to lose weight.
    Location: University of Kansas Cancer Center, Kansas City, Kansas

  • Weight Loss Intervention in Improving Outcomes in Patients with Breast Cancer

    This pilot clinical trial studies how well a weight loss intervention works in improving outcomes in patients with breast cancer. Participating in a standard weight loss program consisting of a reduced calorie diet, moderate exercise, and weekly group meetings may help improve the health in patients with breast cancer.
    Location: University of Kansas Cancer Center, Kansas City, Kansas

  • High-Intensity Interval Training or Moderate-Intensity Continuous Training in Preventing Breast Cancer in High Risk Patients

    This randomized clinical trial studies how well high-intensity interval training or moderate-intensity continuous training works in preventing breast cancer in high risk patients. High-intensity interval training or moderate-intensity continuous training may help to lower biomarker levels that are linked to breast cancer risk and lead to a healthier lifestyle.
    Location: M D Anderson Cancer Center, Houston, Texas

  • 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: MedStar Georgetown University Hospital, Washington, District of Columbia

  • 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. 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

  • Conjugated Estrogens / Bazedoxifene in Reducing Benign Breast Tissue Proliferation and Menopausal Symptoms in Peri or Post-Menopausal Patients at Moderate Risk for Breast Cancer

    This pilot clinical trial studies how well conjugated estrogens / bazedoxifene works in reducing an increase in non-cancerous breast tissue in patients who are experiencing hot flashes due to perimenopause or menopause and who are at a moderate risk for developing breast cancer. Giving conjugated estrogens / bazedoxifene may reduce breast tissue proliferation while also reducing the amount of hot flashes.
    Location: University of Kansas Cancer Center, Kansas City, Kansas

  • Sirolimus in Preventing Invasive Breast Cancer in Patients with Ductal Carcinoma In Situ or Atypical Ductal Breast 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 a singular lobular unit. 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

  • Aerobic Exercise Training in Lowering the Risk of Breast Cancer in Patients at High-Risk for Development of Breast Cancer

    This randomized pilot clinical trial studies how well aerobic exercise training works in lowering the risk of breast cancer in patients at high-risk for development of breast cancer. Aerobic exercise training may help lower the risk of breast cancer patients with risk factors that are associated with developing breast cancer such as exercise capacity, body weight, body composition, the expression of certain genes, and levels of inflammatory factors in breast tissue.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Omega-3 Fatty Acids in Preventing Recurrence in Patients with Hormone Receptor-Negative or HER2-Positive Stage 0-III Breast Cancer That Have Completed Treatment

    This randomized phase II trial studies omega-3 fatty acids in preventing the return of cancer (recurrence) in patients with hormone receptor-negative or human epidermal growth factor receptor (HER2)-positive stage 0-III breast cancer that have completed treatment. Omega-3 fatty acid may help prevent breast cancer from forming in patients at risk for recurrence.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members

    This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Exercise Intervention in Preventing Breast Cancer in African-American Patients With Metabolic Syndrome

    This randomized pilot clinical trial studies exercise intervention in preventing breast cancer in African-American patients with metabolic syndrome. Exercise interventions may keep cancer from forming.
    Location: MedStar Georgetown University Hospital, Washington, District of Columbia

  • Olive Oil for Breast Cancer Prevention in Women at High Risk for Breast Cancer

    This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil, on mammographic density in women at high risk of breast through assessing whether mammographic density is reduced in women at high risk of breast cancer taking hydroxytyrosol for 1 year compared with baseline imaging.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • A Study to Assess the Safety and the Efficacy of IV Fosnetupitant / Palonosetron (260 mg / 0.25 mg) Combination Compared to Oral Netupitant / Palonosetron (300 mg / 0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

    Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intraveneous (IV) fosnetupitant / palonosetron (260 mg / 0.25 mg) infusion [test] versus oral netupitant / palonosetron (300 mg / 0.5 mg) combination [control]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.
    Location: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas

  • Hypofractionated Radiation Therapy in Preventing Recurrence in Patients with Breast Cancer after Surgery

    This randomized phase II trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
    Location: 2 locations

  • NSAID Effects on Clinical and Imaging Breast Biomarkers

    This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.
    Location: The University of Arizona Medical Center-University Campus, Tucson, Arizona

  • 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. Drugs used in chemotherapy, such as bexarotene, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: M D Anderson Cancer Center, Houston, Texas