View clinical trials related to Breast Neoplasms.
Filter by:The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory studies have shown that melatonin may decrease cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot flashes, and mood will also be measured.
Regional lymph node status is the most important prognostic factor for disease-free and overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery. Today, in early-stage invasive breast cancers with clinically negative lymph nodes, minimally invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of regional lymph node staging. To optimize the effectiveness of SLNB, precise pre-and intraoperative mapping of lymphatic drainage is important. The (SLNB) technique is not standardized. The most common and most accurate way of lymphatic mapping is performed with the combined application of a gamma-emitting isotope labeled substance and blue dye, the so-called double labeling technique. Functional lymphatic drainage of SLNB double staining in the mammary gland, skin and axilla present a number of uncertainties. According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided the axillary region into four subregions: brachial (lateral), pectoral (anterior), central and subscapular (posterior) zones. They revealed clear relationship between the anatomic location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in Level I in 96% and in Level II in 4% by SPECT/CT. Knowedge of relationships between the drainage of sentinel lymph node staining into the axillary subregions, location of the primary tumor, tumor size, SLN positivity and its location within the subregion are of particular importance in the decision making whether or not axillary lymphadenectomy (ALND) needs to be performed. In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not performed in early breast cancer patients with clinically negative axilla and breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average follow-up of 6.3 years, data were compared to the traditional ALND group and no difference was detected in 5-year overall survival or disease-free survival at 5 years. Aims of the investigation: To examine the location of SLN in the axillary subregion (anterior, posterior, central, lateral, apical) in patients with early breast cancer (T <5 cm). To statistically assess correlations between the location, size, histological parameters of primary breast tumor and the subregion of the SLN. To statistically assess SLN positivity and its location within the sbregion. To statistically assess subregional localisation of positive SLN and the number of all positive regional lymph nodes, to predict a limited number of cases with lymph node metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be omitted.
This study was designed and developed in the Emilia Romania research and innovation program (PRI ER). The study does not have commercial sponsors and comes under the independent studies provided for by Ministerial Decree 17.12.2005. The PRI ER program will guarantee a contribution to the study for the first three years of recruitment through the regional Innovation Fund, to cover the costs of coordination and data management sustained by the Coordinating Center. Primary Objectives The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery, is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control (incidence of ipsilateral recurrences as prime event). Secondary Objectives Comparison of the global survivals, freedom from locoregional recurrences (with exception for contralateral tumors and second tumors), distant relapse-free (except for local or regional relapses or in the contralateral breast) in patients treated with conventional radiotherapy and accelerated partial radiation. To evaluate whether accelerated partial irradiation offers cosmetic results, acute toxicity comparable with conventional irradiation. Possible connection with other national and international studies Similar studies which nonetheless evaluate different methods of partial irradiation are currently underway. Study Design Multicenter phase III controlled randomized, unblinded study of non-inferiority. Number of cases Recruitment of 3302 patients is planned. Target Population of the Study Women aged = > 49, ECOG 0-2, undergoing conservative breast surgery for invasive breast cancer, pT 1-2 (< 3 cm in diameter) pN0-N1 M0, unifocal, resection margins histologically negative (³ 2 mm) at first intervention or after subsequent widening. Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is planned and a follow-up period of 5 years for an overall duration of the study of 13 years. Treatment The patients will be randomized to receive one of the following treatments: Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval of at least 6 hours between the two fractions, for five consecutive working days. Control arm 50.0 Gy in 25 fractions (2 Gy per fraction), once a day for 5 days in the week. Endpoints Primary: survival free of local ipsilateral recurrence as prime event Secondary: global survival, locoregional recurrence-free, distant recurrence-free, acute and late toxicity (RTOG) and cosmetic result. Evaluation and Follow-Up Program Controls are planned during the radiotherapy, at the end of treatment, at 6 weeks, 3-6-12 months from the end of the radiotherapy and then once a year until the end of 5 years. Data Analysis Partial irradiation will be considered not inferior to the standard irradiation if the top extreme of the HR confidence interval at 95% (to endpoint) does not exceed the established value of 1.5 The study was sized in relation to the rate of local ipsilateral breast recurrences as prime event at 5 years and assuming that this rate in the standard treatment group is 4%, accepting as maximum Hazard Ratio inferior to 1.5 and error a and b equal respectively to 0.05 and 0.10 and test at an endpoint. The survivals will be calculated using the Kaplan-Meier method. The hazard ratio (HR) will be calculated using the Cox model and its confidence interval at 95% will be reported. Ethical Aspects and Informed Consent For participation in the study an informed consent is planned appropriately drawn up and submitted to the approval of the Ethics Committees. The clinical study will be carried out according to the ethical principles of the Helsinki Declaration, the GCP guidelines, the Italian laws and regulatory activities for carrying out clinical studies. Before formal commencement of the study its approval/sole opinion by the reference Ethics Committee of the proposing group is stipulated. The individual investigators of the different participating institutions are directly responsible for the submission for approval of the protocol by their Ethics Committees.
The purpose of this study is to see how the look of telangiectasias (small dilated blood vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's overall well being. Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets red blood vessels and delivers heat causing the telangiectasias to become smaller and less visible. The laser has been used safely to treat telangiectasias on the skin of patients who received radiation for breast cancer. Patients in the study will be asked to complete a questionnaire asking how they feel about the telangiectasias, their radiated skin and its effect on their daily lives. The questionnaire will be given at every visit. The improvement in the look of patients' radiated skin will also be compared to answers to the questionnaire. We hope the study will improve our understanding of how patients feel about the long term effects of radiation on their skin.
To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1 receptor blockade.
Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style. Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program. Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care. Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.
This randomized clinical trial studies an educational intervention for reducing work disability in breast cancer survivors. Web sites providing symptom management education may be an effective method to help breast cancer survivors reduce work disability after treatment
Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation. Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks. Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.
Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients). Fulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy. Everolimus is an orally administered drug that blocks a signaling pathway called "mTOR". "mTOR" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth. The combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant or néoadjuvant chemotherapy.