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This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.
The study is designed to evaluate the effectiveness of liquid crystal contact thermography in detecting pathological changes in female breasts compared to standard diagnostic methods.
500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI
The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.
The role of immunity in the development of cancers, and the associated escape mechanisms, have attracted renewed interest since the publication of tests testing immunological checkpoint inhibitors. One of the steps in the probably least studied immunological response is the penetration of immunocompetent cells within the tumor across the vascular barrier. This infiltration is suggested as a prognostic and predictive marker of treatment response, particularly in triple negative HER2 (Human Epidermal Growth Factor Receptor-2) overexpressing breast cancers. The methods of evaluating these infiltrates are complex and have been the subject of recommendations. A better understanding of the mechanisms of infiltration of immunity cells within tumors will certainly help to better understand the impact of cancer treatments and develop new therapeutic strategies. It is this issue of vascular endothelium that Dr. Soncin's team is developing as part of an INCa (Institut National du cancer) project. The egfl7 / VE-statin (vascular endothelial-statin) gene is thought to be involved in transendothelial passage of immune cells from vascular lumen to tumor. Its expression has already been studied in a series of breast cancers. Other markers of endothelial activation are currently being identified. The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al. that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised. Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation
Elderly cancer patients are a special group, often complicated by a variety of chronic diseases, which bring serious obstacles to surgery and adjuvant treatment. It is for these reasons that most patients with high-level evidence-based randomized controlled clinical trials will be part of these patients. Exclusions ultimately lead to a lack of standards for the treatment of elderly breast cancer patients, especially the chemotherapy. Investigators' purpose was to determine whether geriatric assessments are associated with completion of a chemotherapy course, grade III/IV toxicity or survival in older adults with breast cancer in older patients. Investigators want to prospectively enroll breast cancer patients with age ≥70 years. By recording the pre-treatment baseline laboratory tests and geriatric assessments, through questionnaires, including Karnofsky performance status(KPS), Eastern Cooperative Oncology Group(ECOG), Mini Nutritional Assessment(MNA), Activity of daily living(ADL), Instrumental activities of daily living(IADL), Mini-Mental State Examination(MMSE), Geriatric Depression Scale(GDS), G-8, Vulnerable Elders Survey-13（VES-13） and FRAIL, Tilburg. Investigators want to learn the relationship between the geriatric assessments and chemotherapy toxicity, chemotherapy completion and overall survival. Establish a model for predicting chemotherapy side effects in old breast cancer patients.
The aim of this study is to evaluate the effect of a 6-mo individualized and specialized food-based nutrition intervention program in breast cancer patients' body composition, metabolism and antioxidant activity associated with micronutrients, during antineoplastic treatment. It is a quasi-experimental prospective follow-up study of women with primary diagnosis of invasive breast cancer in Sonora, Mexico. Conducted between September 2015 through July 2018. The Ethics and Research Committees of The Oncology State Centre and the Food and Development Research Centre, have approved the study's protocol and procedures. At baseline, all participants must sign an informed consent form and answer an oral interview, including self-reported questionnaires, for their nutrition record. At the beginning and 6-mo after, participants will be weighed during the morning in a digital scale and height will be measured using a digital stadiometer. Body mass index (BMI) will be calculated and classified according to the World Health Organization criteria. Waist and hip circumferences will be measured with a metal tape, according to the protocol of the International Society for the Advancement of Kinanthropometry (ISAK), by a certified anthropometrist. Body composition components will be measured in a dual-energy x-ray absorptiometry (Hologic Corporation 4500 Waltham, MA) by total body, L1-L4, and femur neck scans. Blood samples will be drawn by a certified phlebotomist using sterile equipment and aseptic techniques. Breast cancer patients' total energy expenditure will be estimated using an algorithm for Mexican population. Diet plans and recommendations will be based on the individual's nutritional status, dietary habits, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein to avoid sarcopenic obesity and considering a caloric restriction (500-1000 kcal/d), when required. The individualized nutrition intervention program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. To guarantee that the obtained content for each macronutrient (g/day) meets the theoretical calculations, protein ±1g/d, total fat ±1g/d, carbohydrates ±2g/d and energy ±15 kcal/d variations will be accepted. Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed, and initial measurements will be repeated. The differences in body composition determinants will be analyzed using paired Student's t-test analysis for each variable. A two-tailed P-value of 0.05 or less will be considered significant. Retinol, tocopherol and carotenoids determination will be performed using HPLC. Serum will be thawed and retinol will be extracted using chloroform:methanol (3:1) and hexane, extracted layers will be combined and then evaporated to dryness under a soft stream of nitrogen. Samples will be re-suspended in ethanol before injecting onto the HPLC using a YMC C-30 column (30 cm length, 4.6 mm internal diameter, 3 µm particle size and 100 mm pore size). The HPLC system is an Agilent 1200 with UV-Vis and PDA detectors. Commercial standards and internal standards will be used to assess concentration and extraction efficiency, respectively. Additionally, the investigators will use a standard NIST serum (National Institute of Standards and Technology; Gaithersburg, Maryland USA). The cut-off point for vitamin A deficient status will be set at < 1.05 μmol /L. The plasma antioxidant capacity will be determined by the trolox-equivalent antioxidant capacity test (TEAC) and oxygen radical absorbance capacity assay (ORAC). For both assays, results will be expressed as millimoles of Trolox equivalents per liter. The effect and their interaction on the response variables will be determined by ANOVA. Tukey's test will be used for the comparison of the means. Values of p<0.05 will be accepted as statistically significant. Human inflammatory cytokines and chemokines will be analyzed by using a panel of 12 pro-inflammatory cytokines as a conventional ELISA protocol all at once under uniform conditions. The cytokines and chemokines represented by this array will be IL1A, IL1B, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNg, TNFa, and GM-CSF. Plasma activities of both enzymes, glutathione peroxidase (GPx) and superoxide dismutase (SOD) will be determined in baseline samples and after 6-mo, by using an ELISA (enzyme-linked immunosorbent assay) based upon a sandwich assay principle and can be used to detect levels of SOD as low as 0.066 ng/mL and 1.56 ng/mL for GPx.
This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.