Active clinical trials for "Breast Neoplasms"

The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects. Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia. Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%

Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm following axillary lymph nodes dissection, and it is associated to a significant functional, psychological and social morbidity, with an heavy impact on life quality. Several studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts. Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when compared with axillary lymph node dissection (ALND) leads to a significant reduction in postoperative complications. However, the advent of SLNB does not solve the problem of BCRL with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost of BCRL rehabilitative treatment is not available in literature yet. Few studies considered incidence, risk factors and treatment costs of BCRL among working-age women after breast cancer treatment, reporting that BCRL population had significantly higher rehabilitative medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications, such as lymphangitis or cellulitis when compared to "BCRL free" population (OR = 2.02, P = .009). Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the primary breast cancer. However, when the arm lymph node correspond to the SLN it should be removed for correct tumor staging, thus a lymphatic drainage disruption onset will be expected with BCRL risk increase. During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful for detecting lymphatic drainage of the upper limb and it allows in differentiating the fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).

Breast cancer is the most prevalent cancer among women worldwide [1]. 5 years after diagnosis, up to 87% survives. A substantial group of these survivors report reduced physical, psycho social and cognitive functioning. Therefore, it is increasingly important to screen for distress, both during and after treatment. The Distress Barometer (DB) is a valid, short screening instrument, used to detect elevated levels of distress in patients with cancer. It can be used either in a self-report questionnaire or in an interview format. Although the DB is used in different ways, it remains unclear whether both assessment methods would generate similar results, and which format is most suitable to represent the actual level of distress. Existing literature on the DB lacks a systematic description of the relationship between the method of assessment and the patients' responses. This study questions whether the written and interview variants of the DB reveal different results in the same patients with breast cancer.

The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.

In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

The breast cancer is composed of multiple biological entities. Recent progress in molecular biology, DNA or RNA chip, permitted the global tumour genome or transcriptome study. Those technics, leads to an increased in the molecular biology knowledge and a better oncogenesis understanding. Breast cancer taxonomy was established following the tumor genetic profile. Moreover this classification is incomplete and didn't include the metabolic pathways other than hormonal or HER2 pathways. The metabolomics is an expanding field of research exploring the metabolites in cells, tissues or biologics fluids. It allows assessing the variation activation of the different cellular metabolic pathways. In oncology, it could highlight the main metabolic disturbances, the interaction of tumor cells and to identify the metabolic pathways involved in oncogenesis using the tumor cells metabolites profiles. Compared to genomic, the metabolomics integrated the impact of the cells environments on the cells biology. The cells environment plays, in fact, a key role in the oncogenesis and in the tumor cells phenotypes. The metabolomics, thus being a complementary approach of the genomic in order to assess a better knowledge of the impact of the extracellular environment on the tumor cell phenotype. In addition, the metabolomics analyses are fast and not expensive compatible with routine practice. The main objective of this study is to highlight a metabolic alteration specific to certain tumors phenotypes in order to have better understanding of the biology of the numerous breast cancer entities and find some biomarkers which could be some possible therapeutic target. Using a high resolution mass spectrometer, the investigators will analyze 52 tumor samples from frozen breast surgical specimen preserved in the Centre Antoine lacassagne tumor bank. The tissue analysis could be associated with a serum sample analysis from the frozen serum bank of the Centre Antoine Lacassagne. With 30 patients who performed a 18 FDG-PET before the surgery, The investigators will analyzed the correlation between the tumoral activation of the glycolysis pathways, quantified with mass spectroscopy and the 18FDG uptake. Using the 17 frozen serums available, the investigators will perform a screening to identify some metabolites or metabolites profile which could be detected in the serum in order to develop a new liquid biopsy approach. This study is a retrospective study based on data and sample already available in the center and collected during the routine practice.

Sacrifice of the intercostobrachial nerve (ICBN) during surgery is associated with development of persistent post-surgical pain (PPSP), which affects up to 60% of breast cancer surgery patients. A large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing post-surgical pain after breast cancer surgery. If the effect of ICBN preservation is consistent with observational studies, the absolute reduction of rates of persistent pain would be considerable.The primary objective is to determine the effect of ICBN preservation, versus usual care, on the prevalence and intensity of PPSP at one year after breast cancer surgery involving axillary lymph node dissection (ALND). Within the larger INSPIRE pilot, we will also be conducting a biomarker sub-study. The objectives of the biomarker sub-study are: 1) to determine the association between pro-inflammatory cytokine levels and the presence and intensity of persistent pain at 3 weeks, and 3 months post-surgery, and) 2) to determine the effect of study intervention on the change in cytokine levels (pre-operative to post-operative) in participants who consent to participate in the sub-study.

The MARIEplus study is a prospective cohort of breast cancer patients recruited into the MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control study of breast cancer conducted in two German study regions, Hansestadt Hamburg and Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and lifestyle factors was collected at multiple time points: at recruitment by a standardized face-to-face interview and at follow-up median 6 years as well as 11 years later using computer assisted telephone interview. Vital status was assessed in 2009 and again in 2015 via the population registries and causes of death were obtained from death certificates and coded according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10). Information on the clinical course was abstracted from medical records to verify clinical events either self-reported in follow-up interviews or reported by treating physicians. The studies were approved by the ethics committee of the University of Heidelberg and the University of Hamburg and conducted in agreement with the Helsinki Declaration. Written informed consent was provided by all participants at baseline and during follow-up. The primary objectives of this study are To assess the association of modifiable lifestyle factors and personal factors, including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone therapy, socioeconomic status, with breast cancer survival, overall and according to tumor type, after accounting for established prognostic factors. To examine the influence of genetic variants on breast cancer relapse and survival To assess the association of lifestyle factors and their changes in the course of survivorship on subsequent breast cancer prognosis. To assess the individual and combined association of inflammation/metabolic biomarkers as well as changes in their serum levels with subsequent breast cancer prognosis overall and according to tumor type. To assess whether and to what extent the associations between breast cancer prognosis and lifestyle factors and/or their changes are mediated by circulating biomarker levels.

This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.

The purpose of this study is to test the usability of the Plan To Thrive smartphone application with cancer survivors. This study will involve three visits (baseline, follow-up, and feedback assessments). Between the baseline and follow-up time points, patients will undergo a 90-day period in which they will engage with app content. It is hypothesized that cancer survivors in this study will find the smartphone application, Plan to Thrive, an acceptable and feasible way to access post-treatment information. In addition, the investigators will explore preliminary efficacy by examining changes over time in primary (patient activation, patient knowledge and adherence to follow-up care recommendations and health behaviors) and secondary outcomes [symptom burden, health-related quality of life and patient satisfaction].