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Breast Neoplasms clinical trials

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NCT ID: NCT01734499 Completed - Breast Cancer Clinical Trials

The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors

CCIP
Start date: October 2012
Phase: N/A
Study type: Interventional

This study is proposed to assess long-term Quality of Life issues in breast cancer survivors by measuring the impact on the quality of life made by the structured "Change Cycle Work Shop" coping class as compared to current local standard of care programs. It has been shown that breast cancer treatment can have long-term bio-psychosocial consequences. Specific evidence-based interventions are needed to address Quality of Life concerns in order to improve the overall outcome of breast cancer and its treatment beyond the focus on mortality rate.

NCT ID: NCT01733628 Completed - Clinical trials for Metastatic Breast Cancer

Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer

BRECOL
Start date: October 23, 2012
Phase:
Study type: Observational

This is a multicenter, post-authorization observational with prospective follow-up (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or metastatic colorectal cancer. The hypertension will be evaluated as a predictor of efficacy of bevacizumab associated with chemotherapy, in terms of progression-free survival (PFS) (Main endpoint). The duration of the study will be approximately 42 months.

NCT ID: NCT01730729 Completed - Clinical trials for Stage IV Breast Cancer

Cabergoline in Metastatic Breast Cancer

Start date: February 11, 2013
Phase: Early Phase 1
Study type: Interventional

Prolactin is a hormone produced in the pituitary gland. Previous studies have revealed that elevated levels of the hormone prolactin might be associated with an increased risk of breast cancer. Cabergoline has been shown to lower prolactin levels in the blood. The purpose of this study is to evaluate the effectiveness of cabergoline in treating metastatic breast cancer disease in those who test positive for the prolactin receptor.

NCT ID: NCT01730612 Completed - Clinical trials for HER2 Negative Breast Carcinoma Expressing CEA

ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA

iTEPsein
Start date: December 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma. Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;

NCT ID: NCT01730118 Completed - Breast Cancer Clinical Trials

Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing

Start date: March 4, 2013
Phase: Phase 1
Study type: Interventional

Background: - Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in several other types of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates, and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune system to recognize HER2. The vaccine, called adenoviral transduced autologous human epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an individual's own immune cells. These cells will be collected and used to produce the vaccine. Objectives: - To test the safety and effectiveness of AdHER2 vaccination. Eligibility: - Individuals at least 18 years of age who have HER2-expressing tumors. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed. - Participants will have an apheresis procedure to collect immune cells to create the vaccine. - Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24. - Participants will be monitored with physical exams, frequent blood tests and imaging studies.

NCT ID: NCT01727362 Completed - Breast Cancer Clinical Trials

Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy

Start date: October 2012
Phase: N/A
Study type: Interventional

The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care.

NCT ID: NCT01727011 Completed - Breast Cancer Clinical Trials

Single Fraction Elderly Breast Irradiation (SiFEBI)

SIFEBI
Start date: November 2012
Phase: N/A
Study type: Interventional

Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. At least eight phase III trials attempting to answer this question and thus provide a sufficient level of evidence to make this concept a new standard of care for sub-groups of patients well defined (1). However, without waiting for the final results of these randomized trials (which will not be fully valid with a drop of at least ten years), the American societies (ASTRO) and European (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups according to the risk to the patient in terms of local recurrence after IPAS. And are defined by the ESTRO: - The low-risk group ("suitable" for ASTRO) - The intermediate-risk group ("cautionary" in ASTRO) - The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group "low risk." The results of phase II trials as a long-term analysis of the matched team of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation photons in low energy X whose results were recently published (5) confirm the value of this new therapeutic concept for post-operative breast cancer at low risk of local recurrence. In France, the therapists were quickly directed to a sub-population for which the IPAS could represent a real improvement in the therapeutic management in significantly reducing the number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6). Several French phase II trials were started specifically targeting the female population aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9). On a technical level, two main approaches are used (10): - Irradiation intraoperative electron or low-energy photons, - Radiation after surgery The advantage of intraoperative irradiation is the optimal reduction of total processing time radio-surgery because the patient is irradiated during the lumpectomy. However, 15-20% of these patients receive partial breast irradiation, as histo-prognostic criteria provided in the histologically final report, confirm the non-adapted indication of IPAS (5). In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days separated by at least 6 hours).

NCT ID: NCT01725633 Completed - Clinical trials for Metastatic Breast Cancer

Aerobic Training in Metastatic Breast Cancer

Breast Mets
Start date: December 2010
Phase: N/A
Study type: Interventional

This study is being done to examine the safety and feasibility of a supervised progressive exercise program in women diagnosed with metastatic breast cancer. Previous research among women with metastatic breast cancer has shown that some of the treatments commonly used in this population may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects in women with early-stage breast cancer receiving common cancer treatments. However, it is not known if supervised exercise training is a safe and feasible intervention in women with metastatic breast cancer. This study is designed to find out if supervised exercise training is safe as the patients undergo treatments for metastatic breast cancer.

NCT ID: NCT01725386 Completed - Breast Cancer Clinical Trials

An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic or Advanced Breast Cancer

Start date: March 2011
Phase: N/A
Study type: Observational

This observational study will evaluate the routine clinical use and the safety and efficacy of Xeloda (capecitabine) in patients with metastatic or advanced breast cancer. Eligible patients will be followed for up to 24 months.

NCT ID: NCT01724606 Completed - Breast Cancer Clinical Trials

Whole Brain Radiotherapy (WBRT) With Sorafenib for Breast Cancer Brain Metastases (BCBM)

Start date: November 5, 2012
Phase: Phase 1
Study type: Interventional

Sorafenib is a new type of anti-cancer drug. It belongs to a new class of medications known as tyrosine kinase inhibitors. Sorafenib is thought to work against cancer in many ways. It helps decrease blood supply to the tumor. It also blocks some proteins that help the tumor cells to grow." Sorafenib is approved by the Food and Drug administration (FDA) for treatment for other cancers like liver and kidney cancer. Sorafenib has also been studied in the treatment of breast cancer that has spread but is not specifically approved for the treatment of breast cancer. It has been studied both as a single agent and also in combination with other anti-cancer therapies for breast cancer. In laboratory models and in some patients with other cancers, sorafenib has been studied in tumors in the brain. In this study, sorafenib will be given together with whole brain radiation therapy (WBRT). Overall this research study is designed to answer 2 main questions: 1. What dose of sorafenib should be used together with WBRT? 2. What are the side effects of sorafenib and WBRT when given together?