Breast Clinic

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Ado-trastuzumab emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients

   Rochester, Minn.

   The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.

2. A Study to Evaluate Chemotherapy-Induced Nausea in Breast Cancer Patients

   Rochester, Minn., Mankato, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

   The long-term goal of this study is to alleviate the occurrence of CIN and fatigue and to improve chemotherapy treatment outcomes. The identification of associations between fatigue, CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie patient symptom experience. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate fatigue and CIN.

3. Understanding the Relationship Between Benign Breast Tissue, Benign Breast Disease, and Breast Cancer Development

   Jacksonville, Fla.

   The purpose of this study is to culture human mammary cells to identify cellular characteristics associated with lobular involution status. 

4. Breast Cancer, Reasoning, And Activity Intervention

   Scottsdale/Phoenix, Ariz.

   This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.

5. A Study to Evaluate the Patient Experience Regarding Image-Guided Percutaneous Breast Biopsy

   Jacksonville, Fla.

   The purpose of this study is to to better understand the concerns of patients prior to a breast biopsy so that we may improve our practice and ultimately enhance overall patient experience.

6. Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

7. Turkey Tail Mushrooms for women with ER+/HER2- Breast Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine changes in proliferation (Ki-67) in ER+HER2-breast cancers that receive turkey tail administration.

    

8. A Study to Evaluate the Immune Response to Anti-HER2 Therapies

   Jacksonville, Fla.

   The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.

9. Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

   Jacksonville, Fla.

   This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in this trial.  Patients will receive VSL#3® 450B sachets probiotics, which will be provided as part of this trial, at least 3 days but preferably 1-2 weeks prior to starting on ICIs. Patients will be followed per standard of care during ICI treatment and continue VSL#3 for 12 more weeks while on ICI. Patients will complete dietary questionnaire and have research blood draws and stool collections at baseline prior to starting VSL#3 and 3 additional time points. Adherence to the probiotic schedule will be captured in a study diary.  Adverse events as well as incidence and severity of IIC will be graded using NCI CTCAE version 5. Patients will have imaging performed per standard of care.

   Primary Goal

   • To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-CTLA-4 +/- anti-PD-1/PD-L1, and (2) anti-PD-1/PD-L1 +/- chemo.  

   Secondary Goals

   • To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.
   • To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.

   Exploratory Goals

   • To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.
   • To evaluate changes in immune response with ICIs and multi-strain probiotic blend.

10. A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

    Rochester, Minn., Jacksonville, Fla.

    This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.