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Breast Cancer clinical trials

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NCT ID: NCT03529383 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer

Start date: May 2018
Phase: N/A
Study type: Interventional

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

NCT ID: NCT03529110 Not yet recruiting - Breast Cancer Clinical Trials

DS-8201a Versus Ado Trastuzumab Emtansine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane

Start date: August 10, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

NCT ID: NCT03524248 Suspended - Breast Cancer Clinical Trials

Development of Real-time Image-guided Radiotherapy

Start date: May 17, 2012
Phase: N/A
Study type: Interventional

The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup or motion errors can be detected and corrected. However, CBCT is not available for situations with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any irregular respiration or body movement during beam-on time. Thus, it is essential to develop a real-time image system that can detect organ/body motion during beam-on time, and correlate simulation-planning images with prior treatment CBCT images.In this proposed clinical trial, we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging techniques and validate the feasibility and accuracy of 4D video image guidance in correlation with 4D CT/CBCT useful for advanced IGRT.

NCT ID: NCT03523585 Not yet recruiting - Breast Cancer Clinical Trials

DS-8201a Versus Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Pretreated With Prior Standard of Care

Start date: August 2018
Phase: Phase 3
Study type: Interventional

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T DM1.

NCT ID: NCT03523572 Not yet recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (DS-8201a) With Nivolumab in Advanced Breast and Urothelial Cancer

Start date: May 2018
Phase: Phase 1
Study type: Interventional

The purpose of this phase 1b study is to test the combination of an experimental drug known as DS-8201a given along with Nivolumab (a marketed drug) in participants with HER2-expressing breast and urothelial cancer who had disease progression during or after prior therapies, did not respond to standard therapies, or for whom no standard therapy is available. The study will be performed in 2 parts. - Part 1 is to look at different doses of DS-8201a when given along with a fixed dose of nivolumab, and establish the most effective and safe dose (maximum/recommended tolerated dose) when used in combination with nivolumab. - Part 2 is to understand the positive or negative effects of this dose combination on the participant's body and disease. The study will also determine the pharmacokinetics of DS-8201a when administered with nivolumab.

NCT ID: NCT03523546 Not yet recruiting - Breast Cancer Clinical Trials

Oncology Episode Payment Model in Hawaii

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

The Oncology Episode Payment Model (EPM) is a payment model designed to test the effects of better care coordination on health outcomes and costs of care for Hawaii Medical Services Association (HMSA) members with cancer who receive chemotherapy.

NCT ID: NCT03520218 Not yet recruiting - Breast Cancer Clinical Trials

Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

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

The goal of this pilot project is to test the new Radialis Positron Emission Mammography (R-PEM) system in breast cancer patients that has a higher sensitivity with lower radiation doses than conventional PET/CT. The plan for the pilot study is to image patients who are already scheduled for diagnostic imaging for breast cancer after a positive core biopsy. Participants will be injected with 5mCi of F-18 FDG and patient will wait for a couple of hours for uptake of FDG. After this time, the first R-PEM scan will occur. Additional optional R-PEM scans can be performed 4 hours after injection and 7 hours after injection with reductions in radiation emission. Additionally, R-PEM images will be compared to standard-of-care breast MRI and digital breast tomosynthesis to study extension of disease and screening of contralateral breast.

NCT ID: NCT03519438 Recruiting - Breast Cancer Clinical Trials

Evaluating Mepitel in Post-mastectomy Patients and the Role of the Skin Microbiome in Radiation Dermatitis

Start date: April 11, 2018
Study type: Observational

The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.

NCT ID: NCT03518957 Recruiting - Breast Cancer Clinical Trials

12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers

Start date: March 12, 2015
Phase: Phase 3
Study type: Interventional

Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.

NCT ID: NCT03518606 Not yet recruiting - Breast Cancer Clinical Trials

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

Start date: June 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.