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Breast Cancer clinical trials

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NCT ID: NCT01516736 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

PROTECT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01515800 Completed - Breast Cancer Clinical Trials

S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer

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

RATIONALE: Measuring how text-message affects treatment compliance in women with breast cancer may help doctors plan the best treatment. PURPOSE: This randomized trial studies how well text-message works in reducing early discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who underwent breast surgery.

NCT ID: NCT01513356 Completed - Breast Cancer Clinical Trials

Pharmacodynamic Study of BKM120 in Breast Cancer

Start date: October 2012
Phase: Phase 0
Study type: Interventional

BKM120 is a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor, currently under investigation in a first-in-man study in patients with advanced solid tumors (wild type and PIK3CA-mutated). Consistent, dose-dependent pharmacodynamic activity has been demonstrated and clear signs of anti-tumor activity have been seen with BKM120.

NCT ID: NCT01513083 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Start date: February 2012
Phase: Phase 1
Study type: Interventional

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01512069 Completed - Breast Cancer Clinical Trials

Efficacy of a Web-based Tailored Self-management Program

Start date: October 2011
Phase: N/A
Study type: Interventional

Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors. Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes [goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined. Hypotheses were following: 1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group. 2. The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group. 3. The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group. 4. The intervention group will show a better HRQOL level compared to the control group. 5. The intervention group will show a better self-efficacy level compared to the control group. 6. The intervention group will show a lower fatigue level compared to the control group. 7. The intervention group will show less anxiety compared to the control group. 8. The intervention group will show less depression compared to the control group.

NCT ID: NCT01511276 Completed - Breast Cancer Risk Clinical Trials

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)

SHAPE-2
Start date: February 2012
Phase: N/A
Study type: Interventional

Physical inactivity and overweight are two accepted risk factors for breast cancer. However, because of their correlation it is not clear which is most relevant to risk. The investigators now set out to study whether physical activity in addition to weight loss by diet only, affects sex hormone levels, known to be related to breast cancer risk. In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight loss group or a control group. The aim of the first two intervention groups is to loose 5-6 kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements are performed at baseline and after 21 weeks, the end of the study period. The aim of this study is to provide insight into the effect of weight loss mainly driven by exercise compared to equivalent weight loss due to nutritional calorie restriction on breast cancer biomarkers.

NCT ID: NCT01510964 Completed - Breast Cancer Clinical Trials

The Involvement of Breast Cancer Patients During Oncological Consultations

INCA
Start date: June 2011
Phase: N/A
Study type: Interventional

The main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist. Other aims are to assess the effect of the intervention on the oncologist's level of patient involvement, on patient satisfaction and coping and to explore the role of key persons accompanying the patient. The investigators expect that patients who have the opportunity to rehearse their informative needs before the consultation will ask a greater number of questions which in turn will determine their greater involvement by the physician and a greater number of satisfied needs. The investigators expect also that the straightforward use of a list of printed questions of potential relevance for cancer patients and their companions at an early stage of illness, by modifying the process of information exchange, increases their participation and satisfaction with the consultation, with potential benefits for treatment adherence and consequently treatment efficacy.

NCT ID: NCT01509963 Completed - Breast Cancer Clinical Trials

The Memorial Sloan-Kettering Cancer Center (MSKCC

NOTEGS
Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this study is to prospectively evaluate the combined use of the MSKCC nomogram (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom additional axillary lymph node dissection (ALND) could be avoided.

NCT ID: NCT01508572 Completed - Breast Cancer Clinical Trials

VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer

Start date: October 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the uptake, (semi-)quantification and localization of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue, surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW is assessed. Another purpose is to assess the abilities of three different fluorescent signal detection systems to detect the fluorescent signal pre- and intra-operatively.

NCT ID: NCT01508273 Completed - Breast Cancer Clinical Trials

Lifestyle Intervention for High Risk Cancer Survivors

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

The goal of this behavioral research study is to find out more about the health behaviors of cancer survivors. Researchers want to understand the cultural, social, and environmental factors related to physical activity and personal diet. Researchers also want to learn if cancer survivors who take part in lifestyle interventions have better overall health and quality of life than those who do not take part in these interventions.