Clinical Research Directory

CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.

This study looks at a new way to treat early-stage breast cancer in older adults using a freezing technique called cryoablation. Older adults with early-stage breast cancer are usually treated with surgery or primary endocrine therapy (hormone therapy). While these treatments can be effective, they may also be burdensome. Surgery can lead to pain, slow recovery, or complications, and primary endocrine therapy often requires long-term medication and may cause side effects or stop working over time. Cryoablation may offer a less invasive treatment option. The goal of this study is to find out whether cryoablation can be safely and successfully used as the main treatment for older adults with early-stage breast cancer. Cryoablation destroys the tumour by freezing it. The procedure is performed through the skin using imaging guidance and does not involve surgical removal of the tumour. Participants in this study are adults aged 70 years or older who have a small breast tumour that has not spread to the lymph nodes. All participants receive cryoablation as a single treatment. After the procedure, participants are followed closely. Researchers will collect information on side effects, recovery, whether additional treatment is needed, and how participants experience the treatment. Quality of life will also be assessed. This study is carried out in several hospitals. All participants must give written informed consent before taking part. The results of this study may help determine whether cryoablation could be a safe and practical treatment option for older adults with early-stage breast cancer and guide future research.

Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial

The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC). A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.

Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy. Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are: 1. How breast cancer responds to endocrine therapy given prior to surgery? 2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will: * receive endocrine therapy as part of regular care for breast cancer * consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor * participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed

Virtual Rehabilitation for Cancer Survivors

Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.

Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors

The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression.

Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making

This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.

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.

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer

A Study of the TheraBionic P1 Device in Breast Cancer

The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.

Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer

Phase III, single-center, randomized, double-blind, placebo-controlled, 2x2 cross- over study, assessing the efficacy of CBD in patients with early HR+ BC, presenting aromatase inhibitor-related musculoskeletal pain

A New Tool to Promote Patient's Engagement in Their Healthcare Process

Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice. Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.

CARE (Chemotherapy Alopecia REduction)

The goal of this research study is to determine if the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients.

Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity

The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.

Taking AIM at Breast Cancer

The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.

Optimizing Surgical Decisions in Young Adults With Breast Cancer

The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions. Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.

Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer

This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients with mild cognitive difficulties during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.

Herbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations

This research study is enrolling participants diagnosed with breast cancer and receiving/received chemotherapy and/or endocrine therapy. The study's primary objective is to assess the differences in the use of herbs and supplements among the populations served at Cleveland Clinic Florida and Ohio by administering a participant-reported questionnaire.

Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients

This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.

Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.

Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study

Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative. (2) Most breast cancer cases can be cured by multimodality treatment, although cure rates vary by clinical stage, subtype and the clinical behavior of cancer which affected by the composition of pro- and anti-tumor immune mediators within the tumor microenvironment. (3, 4) Immune gene signatures in breast tumors -that comprise genes with specialized roles in immune biology- Significantly, have been shown to correlate with patient survival outcomes. (5-8)chemotherapy responsiveness. (7, 9), and more recently, response to immunotherapies.(10-12)One such candidate, the gene encoding Triggering Receptor Expressed on Myeloid Cells (TREM)-1, which emerged as a robust therapy predictive and prognostic marker. TREM1 encodes a type I trans-membrane receptor of the Ig superfamily expressed by effectors of innate immunity including neutrophils, monocytes and macrophages. The TREM-1 receptor is known to augment inflammatory signaling in response to infectious pathogens by promoting release of cytokines that modulate the activation, recruitment and survival of myeloid and lymphoid cells. (13) In this study we hope to gain a better understanding of TREM-1 clinical and molecular relevance in HER2 negative BC either triple negative or hormonal positive which represent significant subset that lack target therapeutic options, evaluating its effect as predictive and prognostic marker and so the potential implications for patient management.

OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes

The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.