Clinical Research Directory

ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)

AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes. The study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden. This study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.

Receptive Music Therapy Effects on Anxiety, Depression, QoL, and EGF, IL-8, and NfL During the Breast Cancer Treatment.

The goal of this clinical study is to investigate whether receptive music therapy can help women with breast cancer by reducing anxiety and depression symptoms, improving quality of life, and influencing specific analytes in plasma, including epidermal growth factor (EGF), interleukin-8 (IL-8), and neurofilament light chain (NfL). Main Questions the Study Aims to Answer: GENERAL OBJECTIVE: To investigate the effect of receptive music therapy on anxiety and depression symptoms, quality of life, and the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma during treatment in women with breast cancer. SPECIFIC OBJECTIVES: * To determine whether there is a correlation between the levels of epidermal growth factor, interleukin-8, and neurofilament light chain in plasma and the severity of anxiety and depression symptoms. * To determine whether there is a correlation between the severity of anxiety and depression symptoms and quality of life. Participants will be randomly assigned to either a music group or a control group. The study will take place during the perioperative period and chemotherapy (in participants for whom chemotherapy will be indicated). At two (perioperative) or three (+ chemotherapy) time points, participants will: * Undergo assessments for anxiety, depression, and quality of life * Provide blood samples for analytes analysis (EGF, IL-8, NfL) * Receive music therapy sessions (for those in the intervention group) The scientific contribution of this study lies in understanding the relationship between the application of receptive music therapy and the plasma levels of epidermal growth factor, interleukin-8, and neurofilament light chain in women with breast cancer during the perioperative period and chemotherapy, as well as its association with the occurrence of pronounced anxiety and depression symptoms related to the malignant process. This study represents the first application of such research in this patient population and serves as a foundation for the future implementation of receptive music therapy in the complementary treatment of breast cancer.

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).

AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc

The study aims to develop educational media interventions to prepare Latinx Spanish-speaking radiation oncology patients for a course of breast or prostate cancer radiation therapy and to foster receptivity and informed decision-making around cancer clinical trial participation.

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).

Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer

BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer

To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.

Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study

There is no granular retrospective data on breast cancer in transgender and gender-diverse (TGD) persons from a contemporary and diverse American cohort. The purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of TGD persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.

The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis

This is a real-world multicentre study to investigate the metastatic pattern of axillary lymph node and its association with breast cancer prognosis.

Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)

The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer

Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Since the publication of IBCSG23-01, ACOSOG Z0011 and AMAROS study, these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNB+ALND followed by adjuvant radiotherapy. Therefore, an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy. However, they also pose new challenges for adjuvant radiotherapy decisions. In the Z0011 study, patients were required to receive breast tangent field radiotherapy. In the AMAROS study, axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area, but the study results showed a local recurrence rate of only 1.19% at 5 years in the axillary radiotherapy group. Consequently, there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients. In contrast, results from the EORTC-22922 and MA-20 studies, which included patients undergoing axillary lymph node dissection, showed that adjuvant radiotherapy to the entire lymphatic drainage area, including the internal mammary region, reduced the risk of disease-free survival and breast cancer-specific mortality. Therefore, the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial, with a lack of high-level evidence to support it.

Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.

Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy. Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study. The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy). The nature of the chemotherapy treatment will be decided according to the standards of each center. The patients will be followed for the study up to 36 months after the surgical procedure.

Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer

The present trial aims to compare the effectiveness of an "intensive" vs a "standard" nutritional intervention on body weight regulation and some metabolic parameters in women on adjuvant/neoadjuvant therapy for breast cancer.

A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery

Background: Breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. Traditional radiotherapy is complex and time-consuming, affecting patient experience. To streamline this, an AI-assisted All-in-one (AIO) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. Preliminary results are promising, with significant time savings and high pass rates in initial assessments. Further exploration is needed to confirm the accuracy, effectiveness, and safety of AIO radiotherapy. Primary objective: To conduct a prospective phase II clinical trial to determine the feasibility (including efficacy and safety) of AIO radiotherapy, and to provide a basis for establishing standard operating procedures. Secondary objectives: To assess the impact of AIO radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. To investigate the incidence and contributing factors of cardiac damage after AIO radiotherapy.

NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.

The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are: Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature. Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.

Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.

Intra-operative Detection of Positive Margins in Breast Surgery

In this project, we will develop a unique OCT-Raman system based on a selective sampling approach optimised for high-resolution analysis of whole lumpectomy specimens. The aim of using OCT is not to detect the cancer but to identify the adipose tissue, such that the large adipose tissue regions are excluded from any further measurements by Raman spectroscopy. While OCT has a limited ability to distinguish between tumour and surrounding normal stroma, adipose tissue has a distinctive appearance in the OCT images due to low backscattering within adipose cells (filled with lipids and small/flattened nuclei) compared to the highly scattering benign dense tissue (stroma, ducts and lobules) and malignant tissue. Such specific patterns allow identification of normal adipose tissue from breast tissue (classification models based on reflectivity profiles) with 94% sensitivity and 93% specificity. This will reduce the task of Raman measurements, which can be focused on the smaller remaining regions to discriminate between the benign and malignant tissue. This flexible and adaptable scanning strategy will achieve a much-improved diagnosis accuracy and speed to cover all surgical margins within practical timescales.

Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania (Fast-ABCD Sequencing)

This pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in Tanzania. It aims to show that nanopore sequencing is non-inferior to the current standard of care, with the potential for faster and more cost-efficient results. By enhancing the speed and accuracy of diagnosis, this approach could improve treatment planning and outcomes for patients in resource-limited settings.

Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab

This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.

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.

Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device

Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up. The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy

The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.