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.

This research evaluates (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor positive (ER+) and HER2-negative breast cancer. The study is open-label and includes two parts: a pharmacokinetic (PK) part to understand how the body processes the drug, and a treatment part to assess the drug's effect on tumor growth by measuring the biomarker Ki-67. The trial is sponsored by Atossa Therapeutics, Inc. and aims to determine if (Z)-endoxifen can slow or stop tumor growth in this patient group. Participants in the PK part receive daily (Z)-endoxifen capsules at doses of 20 mg, 40 mg, or 80 mg, with some also receiving a monthly injection of goserelin, which temporarily stops estrogen production by the ovaries. The treatment part uses a combination of (Z)-endoxifen at 40 mg daily plus monthly goserelin injections. After 4 weeks, tumor tissue is sampled via biopsy to measure Ki-67 levels. If Ki-67 is 10% or less, participants may continue treatment for up to 24 weeks; if greater than 10%, they proceed to surgery earlier. Participants attend regular visits for treatment and assessments, including blood tests and breast biopsies to monitor drug levels and tumor response. The main outcomes measured include (Z)-endoxifen blood concentrations and tumor Ki-67 reduction after 4 weeks, along with tumor response after 24 weeks. Study participation lasts up to 6 months, followed by surgery and a one-month follow-up to evaluate safety and treatment effects.

Researchers are evaluating the use of 18F-FDG PET/CT 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 II/III 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 PET/CT 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 suspected/proven locoregional recurrent breast cancer. The main goal is to determine if the PET/CT 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 CT/MRI 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 PET/CT and PET/MRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PET/CT or PET/MRI 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 PET/CT 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, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT 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 PET/CT 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 exploring the experience of breast cancer patients meeting directly with pathologists to review their pathology slides. This study aims to understand if such encounters help patients feel more informed and empowered about their disease, and also whether these meetings are practical and beneficial for pathologists. This research addresses a relatively new approach since most pathologists typically have little direct patient contact. Participants will meet with a pathologist who will review their breast tissue slides and discuss disease characteristics. The study includes questionnaires to assess patients' understanding and feelings of control over their condition, as well as their overall knowledge of breast cancer pathology. These assessments will be conducted before and after the meeting to measure any changes. During the study, participants will complete knowledge questionnaires and surveys related to their disease and anxiety levels. The primary measure is how well patients understand and feel empowered about their condition after the pathologist visit. Secondary measures include knowledge about their personal disease details and general breast cancer pathology. The study monitoring lasts 1 to 2 weeks following the visit, with no long-term treatment or interventions involved.

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 group's 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.

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 5-strain probiotic formulation called WBF-038 in women with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors reduce estrogen production to help stop cancer cell growth but can negatively affect bone health, weight, and blood sugar. This phase II trial aims to see if WBF-038 can prevent bone loss and improve metabolic health during this treatment. Participants take WBF-038 orally once daily for one year, starting three months after beginning aromatase inhibitor therapy, unless disease progression or unacceptable side effects occur. The study includes blood sample collections and bone mineral density tests at screening and throughout the trial. After the treatment year, participants are followed for an additional 90 days. During the study, researchers measure changes in bone turnover markers like C-terminal telopeptide of type 1 collagen (CTx), lumbar spine and hip bone mineral density, blood sugar levels, weight, waist size, and musculoskeletal symptoms. Safety is closely monitored through adverse event tracking. Patient questionnaires and stool sample analyses are also used to explore metabolic and microbiome changes over time.