Estrogen Receptor (ER) Positive

Breast cancer is a leading cause of death among women worldwide and is classified into subtypes based on hormone receptor and HER2 status. This research focuses on the role of epigenetic regulators, specifically non-coding RNAs like lncRNAs UPK1A-AS1 and UNC5B-AS1, which may influence gene expression involved in breast cancer development. Studying these molecular markers aims to improve diagnosis and prognosis and enhance understanding of breast cancer biology. The study is observational and involves Egyptian female breast cancer patients newly diagnosed with malignant non-metastatic breast cancer, compared to healthy volunteers. Researchers will measure the expression levels of the candidate lncRNAs and their target microRNAs using quantitative real-time PCR in serum and tissue samples. Protein levels related to these markers will be assessed by ELISA. The study will also analyze the relationship between these markers and clinical features such as tumor stage, grade, and known prognostic biomarkers. Participants will provide blood and tissue samples for molecular analysis, and clinical data will be collected from medical records. Laboratory tests include RNA extraction, qRT-PCR, and ELISA assays. The primary outcomes include evaluating the expression and role of the lncRNAs and their targets, comparing them between patients and healthy controls, and correlating these findings with clinical characteristics. The study will last about 12 months, with careful data analysis to explore potential new markers for breast cancer diagnosis and prognosis.

Researchers are studying patients with Luminal A and estrogen receptor-positive ER-positive lobular breast cancer to evaluate a new imaging method. This study aims to assess the use of hybrid PETMRI combined with a radiolabeled form of estrogen called 16-alpha-18F-fluoro-17-beta-estradiol FES for accurate, non-invasive staging of these breast cancers. The study focuses on comparing this imaging techniques ability to detect cancer spread in axillary lymph nodes with the results from axillary surgery. Participants will undergo a single cohort study where they receive primary surgery as their first treatment. Before surgery, they will have an FES PETMRI scan using the radiotracer FES to capture detailed images of their cancer. Selected patients with heterogeneous tumors on imaging will also have further analysis through pathology, imaging, genomic, and radiomic studies to explore tumor characteristics. Throughout the study, participants will be monitored for the sensitivity of the FES PETMRI in detecting axillary lymph node metastases. Researchers will collect imaging data before surgery and compare it with surgical findings. The study involves no masking or placebo and will follow patients from enrollment until after surgery to gather diagnostic performance data. The total study period extends until 2029, with primary outcome assessment planned around 50 days after imaging.

Researchers are evaluating the use of 18F-FDG PETCT imaging to detect breast cancer metastases that conventional imaging methods like CT and bone scintigraphy might miss. This study focuses on women diagnosed with stage IIIII or locoregional recurrent breast cancer, aiming to see if this imaging can improve disease staging and influence treatment decisions. It also explores how imaging and molecular characteristics may relate to patient outcomes such as overall survival and progression-free survival. Participants will undergo an 18F-FDG PETCT scan in addition to the usual CT and bone scintigraphy imaging as part of their cancer assessment. The study includes patients with newly diagnosed high-risk breast cancer or suspectedproven locoregional recurrent breast cancer. The main goal is to determine if the PETCT scan leads to changes in staging or treatment plans compared to conventional imaging alone. During the study, researchers will collect imaging data, including PET parameters and CTMRI measurements, as well as blood and tumor samples for molecular analysis. They will monitor changes in cancer staging and management over five years, along with overall survival. Participants health status will be assessed using the ECOG performance scale, and safety and outcomes will be followed throughout the study period, which runs until 2032.

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive ER breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PETCT and PETMRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PETCT or PETMRI scans. The study focuses on comparing these two diagnostic tracers accuracy in detecting cancer lesions in ER breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating the cosmetic outcomes and quality of life for breast cancer patients undergoing breast reconstruction using 3D-printed biodegradable material breast implants. This study compares these results with traditional breast-conserving surgery and traditional silicone prosthesis breast reconstruction. It also explores the safety and potential medical issues related to using 3D-printed biodegradable implants for breast reconstruction in patients not suitable for breast-conserving surgery. Participants are divided into three groups one group receives breast reconstruction using 3D-printed biodegradable implants, the second undergoes traditional breast-conserving surgery, and the third has traditional silicone prosthesis breast reconstruction. The trial includes preoperative assessments, imaging with MRI, surgical planning with 3D printing of implants for the experimental group, and surgery according to each groups procedures. Postoperative care includes wound management, systemic therapies such as chemotherapy or endocrine therapy, and radiotherapy based on clinical guidelines. During the study, participants undergo regular follow-up with breast ultrasounds weekly for the first month and monthly thereafter, MRI scans at 3, 6, 12, and 24 months, and patient-reported outcome assessments using the BREAST-Q V2.0 scale to evaluate breast aesthetics, satisfaction, and quality of life. Telephone follow-ups occur monthly, with in-person visits every three months. The primary outcome measured is cosmetic effects and quality of life one year after surgery, alongside safety and long-term survival outcomes up to ten years.

Researchers are evaluating a new imaging method called 4FMFES-PET combined with FDG-PET to improve diagnosis and management of advanced estrogen receptor-positive ER breast cancer. ER status is a key factor in guiding treatment choices, but tumors can vary in ER expression over time and across sites. This study aims to assess the full potential of 4FMFES-PET, which has shown better image quality and tumor detection than earlier tracers, in combination with FDG-PET for whole-body, non-invasive ER status evaluation in advanced breast cancer patients. Participants with advanced ER breast cancer will undergo 4FMFES-PET imaging at the start, then again at 6 and 18 months, within 4 weeks of medically prescribed FDG-PET scans. The 4FMFES tracer is given intravenously followed by PET imaging. The study will compare and complement these PET scans with conventional imaging and correlate imaging results with pathology from biopsies and with clinical outcomes like treatment response and progression-free survival. During the study, participants will have multiple PET scans to monitor ER expression and tumor activity over time. Researchers will collect pathological data and track outcomes such as time to recurrence and treatment effects. The main measurements include uptake of 4FMFES on PET scans correlated with tissue markers and clinical progress over 18 to 36 months. This approach aims to better identify patient groups who may benefit from this imaging method to guide their care.

This research aims to compare two radiotherapy approaches for women with breast cancer who are either under 40 years old or have unfavorable tumor types such as lobular carcinoma, certain aggressive subtypes, or triple negative breast cancer. The study focuses on patients with clinical stage T1-T3 and lymph node involvement Nx-N3 after breast-conserving surgery, evaluating whether a shorter, more intense treatment schedule is not worse than the current standard treatment. The trial is prospective, randomized, and designed to assess non-inferiority between these treatments. Participants will receive one of two radiation therapy regimens. One group experimental arm will have whole breast irradiation totaling 26 Gy delivered in 5 fractions, with a simultaneous integrated boost SIB to the tumor bed totaling 30 Gy. The other group standard arm will receive whole breast irradiation totaling 40.05 Gy in 15 fractions, with SIB to 48 Gy. Intensity modulated radiotherapy IMRT plans will be used to optimize coverage and protect organs at risk. Both treatments are given after surgery and may include lymph node areas. During the study, participants will be monitored for local relapse-free survival over 5 years, along with various toxicity assessments at 1 month, 3 months, and up to 5 years. Other outcomes include local control, breast tumor recurrence, regional relapse-free survival, distant metastasis-free survival, disease-free survival, breast cancer-specific survival, overall survival, and cosmetic results. Additional evaluations will assess treatment-emergent adverse events, organ movement, radiomics, and predictive factors for toxicity and disease progression. The study will run through June 2035.

Researchers are evaluating the difference between a 5-day course and a 9-day course of whole breast radiation therapy for women with early-stage breast cancer. This phase II randomized trial aims to compare patient satisfaction and side effects from these two radiation schedules to determine if the shorter treatment is as acceptable as the longer one. The study is sponsored by the University of Utah and focuses on women with specific breast cancer types and stages after lumpectomy surgery. Participants will be randomly assigned to receive either 5 fractions or 9 fractions of hypofractionated radiation therapy to the whole breast, with a boost to the tumor area. The radiation treatments are given over the respective number of days, and the study compares these two schedules to assess differences in outcomes. Both groups receive radiation therapy as directed by the study protocol, with no placebo or masking involved. During the study, participants will be followed for several years to evaluate breast satisfaction using Breast-Q scores and to monitor for radiation-related side effects and cancer recurrence. Various assessments will include cosmetic evaluations using photographic scales and patient-reported outcomes collected at multiple time points up to 5 to 8 years. Safety and effectiveness are monitored through adverse event tracking and cancer surveillance, with total study duration extending up to 8 years after treatment.

Researchers are evaluating a probiotic called WBF-038 in patients with early-stage hormone receptor-positive breast cancer who are beginning treatment with aromatase inhibitors. Aromatase inhibitors reduce estrogen production to help prevent cancer growth but can negatively impact bone health, weight, blood sugar, and waist size. This Phase II trial aims to see if WBF-038 can help prevent bone loss and improve metabolic health during this treatment. Participants receive WBF-038 by mouth once daily for 365 days, starting three months after beginning aromatase inhibitor therapy, unless disease progression or unacceptable side effects occur. During the study, patients undergo blood sample collections and bone mineral density tests at screening and various points throughout the trial. After completing the year of probiotic treatment, participants are followed up for 90 days. Throughout the study, researchers measure changes in bone turnover markers, bone mineral density in the lumbar spine and hips, blood sugar levels, weight, waist circumference, and inflammatory markers. Patient-reported symptoms related to aromatase inhibitor treatment are also assessed. Safety and fracture risk are monitored by tracking adverse events. The total participation is approximately 18 months from baseline to final follow-up.