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A volunteer subject with no known significant health problems who participates in research to test a new drug, device or intervention. These volunteers are recruited to serve as controls for patient groups. Healthy volunteers receive the same test, procedure, or drug the patient group receives.

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Study phase

What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

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  1. Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS

    Jacksonville, FL, Rochester, MN, Scottsdale/Phoenix, AZ

    Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information

    Jacksonville, Fla.

    Open for enrollment

    Scottsdale/Phoenix, Ariz.

    Open for enrollment
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 17-010609
      • Jacksonville, Florida: 17-010609
      • Scottsdale/Phoenix, Arizona: 17-010609

    • NCT ID:

      NCT02926911

    • Sponsor Protocol Number:

      AFT-25

  2. Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer

    Rochester, MN, Scottsdale/Phoenix, AZ, Jacksonville, FL

    Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      I
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information

    Jacksonville, Fla.

    Contact us for the latest status

    Scottsdale/Phoenix, Ariz.

    Open for enrollment
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 17-000106
      • Jacksonville, Florida: 17-000106
      • Scottsdale/Phoenix, Arizona: 17-000106

    • NCT ID:

      NCT02898207

    • Sponsor Protocol Number:

      10031

  3. A Study of the Diagnostic Performance of the Nonlinear Elasticity Parameter Mapping Method with Suspicious Breast Masses

    Rochester, MN

    A Study of the Diagnostic Performance of the Nonlinear Elasticity Parameter Mapping Method with Suspicious Breast Masses

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 14-004964

    • Sponsor Protocol Number:

      14-004964

  4. A Study to Evaluate the Safety, Tolerability, Drug/Body Interactions, and Activity of Oradoxel for Patients with Advanced Malignancies

    Rochester, MN, Scottsdale/Phoenix, AZ

    A Study to Evaluate the Safety, Tolerability, Drug/Body Interactions, and Activity of Oradoxel for Patients with Advanced Malignancies

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      I
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to determine the safety, tolerability, activity, and drug/body interactions of Oradoxel for the treatment of patients who have advanced malignancies.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information

    Scottsdale/Phoenix, Ariz.

    Open for enrollment
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 16-009428
      • Scottsdale/Phoenix, Arizona: 16-009428

    • NCT ID:

      NCT02963168

    • Sponsor Protocol Number:

      KX-ORADOX-003

  5. FASN Inhibitor TVB-2640, Paclitaxel, and Trastuzumab in Treating Patients With HER2 Positive Advanced Breast Cancer

    Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

    FASN Inhibitor TVB-2640, Paclitaxel, and Trastuzumab in Treating Patients With HER2 Positive Advanced Breast Cancer

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This phase II trial studies how well FASN inhibitor TVB-2640, paclitaxel, and trastuzumab work in treating patients with HER2 positive breast cancer that has spread to other places in the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, 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. Giving FASN inhibitor TVB-2640, paclitaxel, and trastuzumab may work better in treating patients with HER2 positive breast cancer.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Open for enrollment

    		View complete study & contact information

    Rochester, Minn.

    Open for enrollment

    Scottsdale/Phoenix, Ariz.

    Open for enrollment
    Print study details

    • Site IRB:

      • Jacksonville, Florida: 16-010066
      • Rochester, Minnesota: 16-010066
      • Scottsdale/Phoenix, Arizona: 16-010066

    • NCT ID:

      NCT03179904

    • Sponsor Protocol Number:

      MC1633

  6. Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

    Rochester, MN

    Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      I
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This pilot phase I trial studies the side effects of direct tumor microinjection and fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has returned after a period of improvement or does not respond to treatment. Injecting tiny amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 16-009337

    • NCT ID:

      NCT03432741

    • Sponsor Protocol Number:

      MC1689

  7. Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors

    Scottsdale/Phoenix, AZ

    Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to find out if ginseng decreases fatigue in people who were treated for cancer.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Scottsdale/Phoenix, Ariz.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Scottsdale/Phoenix, Arizona: 17-006475

    • NCT ID:

      NCT03407716

    • Sponsor Protocol Number:

      MC16C2

  8. The Influence of Exercise Prescriptions on Physical Activity and Other Determinants of Health Among Cancer Survivors

    Rochester, MN

    The Influence of Exercise Prescriptions on Physical Activity and Other Determinants of Health Among Cancer Survivors

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to evaluate the efficacy of a new Mayo Clinic intervention in which preventive cardiology practitioners provide a baseline assessment of the nutritional and functional status and comorbidities of cancer survivors and then develop an individualized, independent exercise program.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 17-005622

    • Sponsor Protocol Number:

      17-005622

  9. Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

    Albert Lea, MN, Eau Claire, WI, Mankato, MN, Rochester, MN, Jacksonville, FL, La Crosse, WI

    Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information

    Jacksonville, Fla.

    Open for enrollment

    Eau Claire, Wis.

    Open for enrollment

    Mankato, Minn.

    Open for enrollment

    Albert Lea, Minn.

    Open for enrollment

    La Crosse, Wis.

    Open for enrollment
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-002576
      • Jacksonville, Florida: 18-002576
      • Eau Claire, Wisconsin: 18-002576
      • Mankato, Minnesota: 18-002576
      • Albert Lea, Minnesota: 18-002576
      • La Crosse, Wisconsin: 18-002576

    • NCT ID:

      NCT03414970

    • Sponsor Protocol Number:

      A221505

  10. A Study of to Evaluate Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

    Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

    A Study of to Evaluate Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to evaluate combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer in order to influence estrogen receptor (ER) signaling.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information

    Scottsdale/Phoenix, Ariz.

    Open for enrollment

    Jacksonville, Fla.

    Contact us for the latest status
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-011037
      • Scottsdale/Phoenix, Arizona: 18-011037
      • Jacksonville, Florida: 18-011037

    • NCT ID:

      NCT02907918

    • Sponsor Protocol Number:

      201610019
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