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Breast Cancer clinical trials

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NCT ID: NCT02586025 Completed - Breast Cancer Clinical Trials

Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel

PEONY
Start date: March 14, 2016
Phase: Phase 3
Study type: Interventional

This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months.

NCT ID: NCT02585362 Completed - Breast Cancer Clinical Trials

Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Start date: March 2016
Phase: N/A
Study type: Interventional

This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.

NCT ID: NCT02583815 Completed - Breast Cancer Clinical Trials

Feasibility of Activity Monitoring in Patients With Cancer: Physical Activity Monitoring in Cancer Patients (PAMCaP)

PAMCap
Start date: August 2015
Phase:
Study type: Observational

This is an open label feasibility pilot study of commercially available physical activity monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.

NCT ID: NCT02583568 Completed - Breast Cancer Clinical Trials

Fluorescence Guided Surgery in Breast Cancer

MARGIN
Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.

NCT ID: NCT02581956 Completed - Breast Cancer Clinical Trials

Walking Affecting Immunology and Quality of Life of Breast Cancer Patients

Start date: November 2008
Phase: N/A
Study type: Interventional

Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is increasing probably due to the prolonged life expectancy and a variety of environmental factors. Fortunately, breast cancer outcome and survival are improving due to early detection and new treatment modalities. After making first strides against breast cancer, i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a series of chemotherapy, which could prolong their survival but almost inevitably downgrade their quality of life due to grueling side effects, such as lack of energy and vulnerability to infection. Numerous medical interventions have been tried by healthcare providers to alleviate these side effects, but some of them are expensive and therefore become another burden for the cancer-afflicted patients. Previous studies have already indicated that exercise generated long-term benefits to breast cancer survivors, including improved physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both immune function and quality of life. Among a variety of exercises, walking is the least costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap some benefit either physically or psychologically. Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T helper cells, play an assistant role in the immunologic process, such as maturation of B cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a widely adopted tool to evaluate patient's individual health status. By means of serial blood sample collections and the delivery of SF-36 survey, this study aimed to objectively and quantitatively evaluate the effects of aerobic walking on the breast cancer patients undergoing chemotherapy.

NCT ID: NCT02580799 Completed - Breast Cancer Clinical Trials

Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples

Start date: February 2014
Phase: N/A
Study type: Observational

A multi-center non-interventional, in-vitro trial for evaluation of concordance of the results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the Immunohistochemical (IHC) method in pathological samples collected from participants with breast cancer.

NCT ID: NCT02580448 Completed - Breast Cancer Clinical Trials

CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)

CLARITY-01
Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to determine the safety, pharmacokinetics, pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.

NCT ID: NCT02574507 Completed - Breast Cancer Clinical Trials

Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

Start date: October 2015
Phase: N/A
Study type: Interventional

The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.

NCT ID: NCT02574455 Completed - Breast Cancer Clinical Trials

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

ASCENT
Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

NCT ID: NCT02569294 Completed - Breast Cancer Clinical Trials

Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being

GIBC
Start date: January 2013
Phase: N/A
Study type: Interventional

This is a clinical non-randomized prospective study. This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer, at three times after the end of the interventions (just after the end, at a 3-month and at a 9-month follow-up).