Prevention Clinical Trials for Breast Cancer

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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 27
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  • Atorvastatin Calcium in Preventing Cardiovascular Complications in Patients with Newly Diagnosed Stage I-III Breast Cancer or Stage I-IV Lymphoma Undergoing Anthracycline-Based Chemotherapy

    This randomized phase II / III trial studies atorvastatin calcium in preventing cardiovascular complications in patients with newly diagnosed stage I-III breast cancer or stage I-IV lymphoma undergoing anthracycline-based chemotherapy. Atorvastatin calcium may help prevent cardiovascular complications caused by drugs used in chemotherapy.
    Location: 42 locations

  • 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: 21 locations

  • A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

    The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
    Location: 7 locations

  • Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax

    The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide / granulocyte macrophage-colony stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is node-positive (NP) (or node-negative [NN] if negative for both ER and PR) breast cancer patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care therapy. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed. E75 is a CD8-eliciting peptide vaccine that was restricted to HLA-A2+ or HLA-A3+ patients (approximately two-thirds of the US population), and has been extended to HLA-A24+ and HLA-A26+ as well.
    Location: 6 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

  • Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema

    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: 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: 4 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 be more effective in treating 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

  • Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy

    This phase II randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.
    Location: 3 locations

  • 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

  • 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 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 BRCA-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 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

  • Metformin Hydrochloride in Reducing Obesity-Associated Breast Cancer Risk

    This phase II randomized trial studies the side effects and how well metformin hydrochloride works in reducing obesity-associated breast cancer risk. Metformin hydrochloride may help prevent, stop, or delay breast cancer from forming by reducing some of the risk factors associated with breast cancer such as breast density, certain proteins and hormones, certain metabolites produced by the body, body weight, and waist and hip sizes.
    Location: The University of Arizona Medical Center-University Campus, Tucson, Arizona

  • Curcumin in Reducing Inflammatory Changes in Breast Tissue in Obese Patients At High Risk for Breast Cancer

    This randomized pilot clinical trial compares whether a higher or lower dose of a new formulation of curcumin will reduce inflammatory changes in breast tissue in obese patients at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may lower the risk of developing breast cancer.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer

    This randomized clinical trial studies metformin hydrochloride in overweight or obese patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the expression of early tumor makers in breast tissue of patients at increased risk for breast cancer.
    Location: Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis, Indiana

  • Metformin Hydrochloride and Lifestyle Intervention in Improving Biomarker Levels in Blood Samples From Stage I-IIIA Breast Cancer Survivors

    This randomized clinical trial studies metformin hydrochloride and receiving health information or a telephone-based weight loss intervention in improving biomarker levels in blood samples from stage I-IIIA breast cancer survivors. Studying samples of blood in the laboratory from patients receiving metformin hydrochloride and a lifestyle intervention may help doctors understand the effects of metformin hydrochloride and lifestyle interventions on biomarkers.
    Location: University of California San Diego, San Diego, California

  • 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


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