View clinical trials related to Breast Neoplasms.
Filter by:To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.
This subproject is included in a project coordinated between program groups Evaluation of Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is to evaluate different aspects of health care received by patients with breast cancer from the diagnostic process, treatment, complications, survival and quality of life, to provide information to improve the effectiveness of interventions, reduce variability, have best predictive rules and increase the quality of life. The main objective of the subproject is to create and validate prospectively predictive rules of recurrence, complications, mortality, changes in quality of life in these patients at admission and one/two years of treatment and to evaluate the external validity of our rules to predict relapses, complications and mortality in the retrospective sample of patients participating in screening programs. Observational methodology with information available from a retrospective cohort of women diagnosed between 2000 and 2009 and another 2-year prospective follow-up included 2040 incident cases of breast cancer in 18 hospitals of 5 regions. Cohorts will learn clinical and health care diagnosis, tumor, treatment, hospital, follow-up (complications, relapse, and vital status) cost and quality of life. Prediction rules are created by means of regression/Cox models at the prospective sample and also investigators will assess the external validity in the retrospective cohort in the case of recurrence, complications and mortality. Expected results: There are currently no results of cohort analysis of the diagnostic process of care that integrates different aspects. The study will create tools to assist prognostic and therapeutic decision making process in these patients
For most breast cancer patients, surgery is the primary treatment. When patients undergo a lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which results in incomplete tumor removal as determined by a positive margin assessment several days after the initial surgery is completed. Most patients with positive margins will undergo a second or even a third surgery to complete the tumor removal. The investigators hypothesize that the LUM Imaging System can reduce the rates of positive margins and, thus, the rates of second surgeries by identifying microscopic residual cancer in the tumor bed. This is a non-randomized, open label study to evaluate the safety and efficacy of an intraoperative imaging system, the LUM Imaging System (LUM015 in conjunction with LUM 2.6 Imaging Device), in identifying residual cancer in the tumor bed of female breast cancer subjects. The study is composed of a Feasibility Trial divided into two phases: Phase A (15 total subjects) and Phase B (up to 50 total subjects). During Phase A, 15 subjects will be evaluated to collect additional patient safety data, select the dose of LUM015 for Phase B and evaluate the device function. During Phase B, subjects will be injected with LUM015 at the dose determined during Phase A to preliminarily assess the performance of the detection algorithm against pathology margin assessment. In Phase B, the surgeon will perform standard of care surgery and then use the LUM Imaging System to guide the removal of additional cavity shavings as indicated by the LUM Imaging System.
To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery. Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women in both arms will complete a number of surveys including questionnaires on fatigue, pain, depression, sleep, and social support. In addition, a blood sample will be collected prior to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of inflammatory biomarkers, and their potential association with exercise and fatigue.
This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.
It has been found that the chemical changes that take place in a patient's body during the development of inflammation may provide an environment which stimulates cancer cells. One step in the development of inflammation is the production of certain chemical substances which are important in the formation and spread of tumours. These are called prostaglandins. Cyclo-oxygenase II (COX-2) is an enzyme (a substance that speeds up chemical changes in the body) involved in the production of these prostaglandins and although it is not usually present in most tissues it is made at the sites of inflammation. Celecoxib is a selective Non-Steroidal Anti Inflammatory Drug (NSAID) which works by blocking the action of the COX-2 enzyme, leading to a decrease in the production of prostaglandins and a reduction in inflammation. The purpose of this study is therefore to find out if celecoxib can be used after breast cancer treatment (chemotherapy and/ or radiotherapy) to reduce inflammation and thus reduce the ability of new tumours to grow and survive. 2590 women with primary breast cancer will be recruited in this study from several locations in the United Kingdom and Germany. Eligible patients will be randomly allocated a treatment group, which can be celecoxib or placebo. Both treatments are taken orally (celecoxib 400mg daily, placebo 2 tablets daily) for a total of 2 years. In addition, hormone receptor positive patients will receive endocrine treatment as per local practice. Patients will prematurely discontinue treatment with celecoxib/placebo if disease progression is confirmed or if patients experience unacceptable toxicity. Patients will be seen every 6 months for the first 3 years and then off treatment follow-up is carried out annually. Participating patients will also be given the option to take part in the pathology sub-study by donating a sample of the tumour tissue collected at the time of the primary surgery.
In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of Neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of Neupogen daily injection. Neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost. This study will use an "integrated consent model" that involves an "oral consent" rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost. While determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.
This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.