Breast Fibroadenoma

The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.

This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.

The study will consist of two phases, I and II. Phase I will include patients with metastatic TNBC, HER2/neu-negative and hormone resistant breast cancer. A total of 4 doses of sarilumab will be given with the starting dose of 150 mg SQ at 3-weeks cycles given 3 days prior to each of the first 4 of 8 cycles of capecitabine (1000 mg/m2/BID; for 14 days every 21 days). If dose escalation is possible, sarilumab will be administered every 3 weeks at 200 mg SQ for 4 doses. Blood samples will be obtained prior during the course of treatment. Bone marrow samples are optional. Phase II is a single arm study in Stage I to III TNBC with less than a complete pCR after neoadjuvant therapy evaluating the combination of sarilumab with capecitabine (1000mg/m2/BID; for 14 days every 21 days) as compared to historical control patients treated with capecitabine alone. There are 8 cycles of capecitabine. The first 4 cycles will be combined with sarilumab. The Phase II sarilumab dose will be determined by the Phase I best tolerated dose. Blood samples will be obtained prior during the course of treatment. Bone marrow samples are optional. A pilot parallel biological baseline study of standard adjuvant capecitabine in stage I to III TNBC with less than a pCR will be performed. This Arm will be open in parallel with both Phases 1 and 2. Blood samples will be obtained prior during the course of treatment. Bone marrow samples are optional.

The purpose of this study is to understand why different people have different risks and outcomes for breast cancer and non-breast cancer.

PERSEVERE is a prospective, multi-modal cohort study designed to evaluate treatment-related toxicities and quality of life in people with stage I-III early breast cancer receiving local therapy in China. Participants will be eligible if they either: Receive neoadjuvant therapy (such as chemotherapy or targeted therapy) prior to surgery, or Undergo surgery followed by postoperative adjuvant therapy, including chemotherapy, radiotherapy, endocrine therapy, or targeted therapy. The study does not include individuals with recurrent or metastatic breast cancer. Study Objectives and Methods This study aims to understand the short- and long-term physical, psychological, and social effects of breast cancer treatment and how they impact participants' recovery and daily life. At baseline, the study collects comprehensive information on participants': Sociodemographic status: marital status, education level, and household income Anthropometric measurements: height, weight, body mass index (BMI), waist and hip circumference Medical history: personal medical history, comorbidities, and past treatments Reproductive history: menstrual and fertility history Participants also undergo baseline clinical assessments, including: Echocardiography (e.g., LVEF) to screen for cardiotoxicity Pulmonary function testing, conducted for participants aged 70 or older Routine laboratory tests, such as liver and kidney function, lipid metabolism, and inflammation markers Biospecimens collected at baseline include: Peripheral blood (plasma and PBMCs) Tumor and adjacent normal tissue from surgery These samples are stored for future biomarker discovery, multi-omics analyses, and translational research on treatment-related toxicities. Following baseline assessments, participants complete a series of validated patient-reported outcome (PRO) questionnaires, which provide insight into their physical symptoms, emotional well-being, and quality of life. These include: EORTC QLQ-C30 and QLQ-BR23 for cancer-related quality of life HADS (Hospital Anxiety and Depression Scale) Pittsburgh Sleep Quality Index (PSQI) for sleep disturbances Brief Pain Inventory - Short Form (BPI-SF) Perceived Stress Scale (PSS-10) for psychological stress Social Support Rating Scale (SSRS) for social support assessment Follow-up and Data Collection Participants are followed using standardized electronic questionnaires administered via the REDCap platform at: Postoperative week 1, month 1, month 3, and every 6-12 months thereafter for up to 5 years No repeat biospecimen or clinical tests are collected after baseline. Follow-up focuses on tracking changes in symptoms and quality of life through PROs, enabling analysis of individual recovery trajectories. Quality Assurance Data collection uses REDCap with built-in logic and range validation A structured data dictionary ensures consistency across sites SOPs guide recruitment, consent, biospecimen handling, adverse event reporting, and data entry Source data verification will be conducted on a sample of participants Missing data will be managed using statistical imputation and sensitivity analysis Study Innovation and Impact PERSEVERE is one of the first large-scale prospective cohort studies in China specifically focused on treatment-related toxicities and quality of life in breast cancer patients. It is designed to: Capture a comprehensive picture of treatment-related toxicities, beyond acute effects Enable integrative analysis of biological, physical, and psychological indicators Build a clinical-biological dataset for developing prediction tools and AI-driven recovery models Guide personalized supportive care strategies based on Chinese breast cancer patients' needs The findings will provide new insights into survivorship and recovery and help clinicians deliver evidence-based, patient-centered care.

Permittivity is the measure of a material's ability to store electrical energy in the electric field. Different materials are known to have different permittivity including the human body. Research is looking into utilising permittivity differences in the human body to detect cancer. There is a particular focus in breast cancer because it is the most common type of cancer in women globally, and research has shown that permittivity of healthy breast tissue is different to cancer tissue. Furthermore, breast tissue can be easily accessible by non-invasive means and has well-established tools available to support cancer detection. However, results from many studies vary greatly and more research is needed to understand how permittivity can be used in cancer research. Zedsen Limited has developed a permittivity measuring device (Z-scanner) capable of measuring a material's permittivity. The purpose of this study is to establish the permittivity of healthy, benign, and cancer tissue associated with the Z-scanner. 90 women attending a routine screening assessment clinic or a one stop clinic at Charing Cross Hospital will be recruited over the course of a year. The study is split into 2 parts. Part A will recruit 20 participants to assess whether scanner results can be repeated and reproduced by different users and hardware. Part B will recruit 70 participants to assess whether the Z-scanner can differentiate between benign and cancerous lesion. All participants will have both their breasts scanned using the Z-scanner during their routine appointment. This allows us to investigate the ability of the Z-scanner to identify and differentiate benign and cancerous lesions from healthy breast tissue based on permittivity. Results from this study can further our understanding on how permittivity and such devices can be used in cancer research.

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.

Guidelines for node marking: Sites are advised to follow the same standards used in the ongoing ATNEC breast cancer trial. At least three nodes should be removed to allow adequate assessment of nodal tumour burden. Timing: The node may be marked at the time of needle biopsy or at a separate visit. Technique: Node may be marked using any technique e.g. clip or coil (with or without skin mark), black dye, magnetic seeds or reflector. Black dye node marking: Inject 0.2-0.4 ml of black dye into the cortex of the node Do not inject around the node or into the needle tract If the marked node is not found or if multiple black nodes are identified the surgeon may stop once a total of four nodes have been removed Single vs multiple node marking: It is not necessary to mark more than one node, even if multiple nodes are biopsied or appear malignant. The most abnormal-appearing node should be marked.

This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.

Breast cancer is the most prevalent cancers among women worldwide. Current diagnostic modalities have notable limitations. Mammography exposes patients to harmful ionising radiation whilst MRI often requires intravenous contrast agents. Additionally, diagnosing breast cancer frequently relies on invasive biopsies, which can cause patient discomfort. This study investigates the potential use of two optical modalities, diffuse reflectance spectroscopy (DRS) and photoacoustic imaging (PAI), as non-invasive diagnostic tools for breast tissue analysis. Advantages include use of non-ionising radiation, contrast-free imaging, and the ability to assess tissue properties in detail. DRS is a non-image based hand-held modality that utilises white light to generate optical signals. PAI is a hybrid biomedical imaging modality that combines traditional ultrasound with optical imaging. The latter generates a functional image that can potentially assess oxygenation levels which is known to be different in healthy vs cancerous tissue. The study will focus on analysing three types of human breast tissues: healthy tissue, benign lesions (such as fibroadenomas), and malignant lesions (invasive breast carcinomas). By identifying the unique optical signatures of each tissue type, the research aims to evaluate the feasibility of these optical techniques as complementary tool to traditional imaging methods for diagnosing or monitoring breast cancer in the future.