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Breast Cancer clinical trials

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NCT ID: NCT03205176 Completed - Breast Cancer Clinical Trials

AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas

Start date: June 30, 2017
Phase: Phase 1
Study type: Interventional

This is a first-time-in-man (FTIM) multicenter, dose escalation study designed to investigate the safety, pharmacokinetics, and pharmacodynamics of AZD5153 in patients with malignant solid tumors, including lymphomas.

NCT ID: NCT03200704 Completed - Breast Cancer Clinical Trials

A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

FILM-B
Start date: January 4, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.

NCT ID: NCT03200639 Completed - Physical Activity Clinical Trials

Cachexia in Gynecological Cancer and the Preventive Role of Weight Training

Start date: May 30, 2015
Phase: N/A
Study type: Interventional

The study aim was to compare the effectiveness of combined training (CT; aerobic + resistance exercises) and high-intensity interval body weight training (HIITBW) on body composition, metabolic and inflammatory profile, physical function and quality of life in older women with gynecological and breast cancer and their pair-matched controls (older women with no cancer). The hypothesis of the present clinical trial is that HIITBW is effective as well as CT for improvements on body composition, metabolic and inflammatory profile, physical function and quality of life in older women with gynecological and breast cancer.

NCT ID: NCT03199586 Completed - Breast Cancer Clinical Trials

Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

Start date: December 21, 2017
Phase: Phase 1
Study type: Interventional

Phase 1 A: First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X 28 days followed by a 14 day rest period.

NCT ID: NCT03197389 Completed - Breast Cancer Clinical Trials

Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.

Start date: January 18, 2018
Phase: Early Phase 1
Study type: Interventional

The study consists of 2 parts: a retrospective study, and a prospective clinical study with pembrolizumab (Keytruda®) (Phase 0). 1. Retrospective study (S58910): This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes (TILs), proliferation, expression of apoptosis and clinical outcome (development of distant metastases). 2. Phase 0 study: This is a Phase 0 single center, open-label, non-randomized, study in patients with early breast cancer. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0 study will consist of 2 cohorts; cohort A will include patients who are scheduled for upfront surgery. Cohort A1 will include patients with Her2 negative tumors, Cohort A2 patients with Her2 positive tumors and Cohort A3 with ER positive tumours. Cohort B will include patients who received neoadjuvant chemotherapy (with anti-Her2 therapy if Her2 positive) and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Cohort B1 will include Her2 negative tumors, Cohort B2 Her2 positive tumors and Cohort B3 ER positive tumors. The injection will be given in the oncological outpatient unit. Patients will be monitored carefully for the development of adverse experiences/events. Adverse experiences/events will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

NCT ID: NCT03196635 Completed - Breast Cancer Clinical Trials

Patient-Assisted Compression - Impact on Image Quality and Workflow

Start date: June 19, 2017
Phase: N/A
Study type: Interventional

This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled [TC]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.

NCT ID: NCT03195322 Completed - Breast Cancer Clinical Trials

Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Primary Objective: • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Secondary Objectives: - To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement - To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. - To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement. - To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. - To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. - To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant. - To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. - To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. - To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant. - To describe the patient's final assessment of pre-pectoral reconstruction from free-form text. Tertiary Objectives: • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.

NCT ID: NCT03194997 Completed - Breast Cancer Clinical Trials

Pilates and Dance to Breast Cancer Patients Undergoing Treatment

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Breast cancer is one of the most common types of cancer in Brazil, and its treatment, namely surgery, chemotherapy, radiotherapy or hormone therapy, has consequences and side effects that significantly affect the quality of life and associated physical and psychological factors. The practice of physical activity, in turn, may play a beneficial role in these factors, and help the recovery of the patient in relation to the consequences of the treatments. Two types of physical activity can be addressed in the context of breast cancer; Dance and the Pilates method. Thus, the objective of the present study will be to analyze the impact of Pilates practice and dance on quality of life and on psychological and physical factors in patients undergoing adjuvant treatment of breast cancer. Patients older than 18 years who are in adjuvant treatment, namely, chemotherapy, radiotherapy and / or hormone therapy at the Oncology Research Center - CEPON, will be invited to be part of the study. With a randomized clinical trial of three arms, the patients will be submitted to 16 weeks of intervention, and randomized in 3 groups: (A) belly dance protocol group; (B) Pilates method protocol group, and (C) control group who will continue with their routine activities. Sample randomization will be conducted in confidence by one of the researchers in a specific computer program. Information about personal and clinical characteristics, quality of life, psychological factors (depressive symptoms, body image, self-esteem, optimism, perceived stress, fatigue, pain, sexual function and sleep quality) and physical factors (cardiorespiratory fitness, balance , Posture, upper limb functionality and presence of lymphedema). All information will be collected before and after the intervention period. Statistical analysis will use the statistical package SPSS - IBM, version 20.0. Firstly, descriptive statistics (mean, standard deviation and percentage) will be used in order to know the data, and then the Anova two way test with repeated measurements and Sydak Comparison Test, in order to analyze the data. Groups of the Pilates method, of the dance and control group. Significance level of 5%.

NCT ID: NCT03194399 Completed - Breast Cancer Clinical Trials

Development of Personalized Health Care Service in Patients With Breast Cancer

Start date: November 27, 2015
Phase: N/A
Study type: Interventional

In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).

NCT ID: NCT03190720 Completed - Breast Cancer Clinical Trials

Development of Exercise Promotion Program Using a Mobile Community

Start date: January 30, 2018
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.