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Breast Neoplasms clinical trials

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NCT ID: NCT03269981 Active, not recruiting - Breast Neoplasm Clinical Trials

Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer

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

This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).

NCT ID: NCT03266809 Completed - Clinical trials for Breast Cancer Female

CARdiac Function Evaluation in Breast Cancer Patients

CARE-B
Start date: August 1, 2017
Phase:
Study type: Observational

This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT: chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm and cardio-respiratory fitness in recently diagnosed breast cancer patients. In some patients, SAT damages the heart (so-called 'cardiotoxicity') and this can have a serious impact on the patient's quality of life and overall survival. It has also been suggested that anticancer therapies may lead to repolarization abnormalities, QT prolongation and autonomic dysfunction, clinically reflected by an increase in HR and a reduction in heart rate variability (HRV). There is a lack of information in the literature regarding the extent and time-course of changes in cardiac function, cardiac rhythm and cardio-respiratory performance ('fitness') in these patients. Moreover, the differential influences of specific treatment regimes (e.g. SAT or SAT plus radiotherapy) and different chemotherapy drugs on cardio-respiratory performance remain unclear. A better understanding of these issues is the primary aim of this study.

NCT ID: NCT03266744 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study

RESPECT
Start date: April 21, 2016
Phase: N/A
Study type: Interventional

This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment. Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.

NCT ID: NCT03266562 Withdrawn - Breast Neoplasm Clinical Trials

Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography

PEM-FES
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.

NCT ID: NCT03265574 Completed - Breast Cancer Clinical Trials

PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?

PROACT
Start date: October 4, 2017
Phase: Phase 3
Study type: Interventional

PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI) enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and non-Hodgkin lymphoma undergoing adjuvant epirubicin-based chemotherapy.

NCT ID: NCT03265379 Recruiting - Breast Cancer Clinical Trials

Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection

Start date: August 22, 2017
Phase:
Study type: Observational

Although chest wall recurrence of breast cancer is uncommon, it represents a difficult clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer recurrence in the chest wall is controversial and is complicated by the fact that no prospective evidence exists evaluating the utility of FTCWR in prolonging survival or improving health related quality of life (HRQOL) and thus, there is a lack of evidence to guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data in a prospective fashion is thus critical in this population. Therefore, we designed a prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and short-term morbidity and mortality, with secondary focus on potential long-term overall survival benefit.

NCT ID: NCT03262935 Completed - Clinical trials for Metastatic Breast Cancer

SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

TULIP
Start date: December 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

NCT ID: NCT03262831 Completed - Breast Cancer Clinical Trials

Mindful Movement in Women Receiving Adjuvant or Neoadjuvant Therapy for Breast Cancer

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

The investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. The investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. The investigators predict that this will be associated with decreased markers of inflammation. The investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. This study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.

NCT ID: NCT03262428 Completed - Breast Cancer Clinical Trials

Collaborative Self-Management Support in Chronic Conditions - Qualitative Study

CoSMaS-ql
Start date: April 14, 2018
Phase:
Study type: Observational

The management of chronic conditions is a challenge for health systems worldwide, particularly in the context of an aging population, and requires urgent improvement of health services. Integrated care and patient empowerment represent promising solutions: offering tailored self-management support in a collaborative framework led to good results in several clinical contexts. Yet, large scale implementation remains a challenge. An important limitation of existing solutions is a lack of utilization of behavioural and communication theory for identifying the dynamics of pluridisciplinary collaboration and the interactive effects of the activities performed by several actors involved in self-management support in a given chronic condition. A second limitation is not involving all relevant actors in the development of health service improvement solutions, which leads to limited programme adoption and sustainability in routine care. This study is part of a project that proposes to address these limitations and develop and interdisciplinary model of collaborative care in the self-management of chronic conditions (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative study that will consist of semi-structured interviews with several types of stakeholders: patients, caregivers, and health care professionals of different specialties (e.g. general practitioners, nurses, specialist consultants, pharmacists). The main objective of the study is to explore the experiences and of patients, caregivers, and HCPs on how self-management support is currently delivered in asthma, cancer and stroke (content, communication, organisation of care), their needs related to self-management support provision, and envisaged solutions for improving current practice. Three different chronic conditions will be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via grounded-theory and template analysis. It will inform the development of a theoretical model of collaborative self-management support in chronic conditions. It will also result in three profiles describing 'real' versus 'ideal' care processes, which will represent needs assessment stages for future health services improvement interventions in the three conditions.

NCT ID: NCT03261323 Withdrawn - Breast Cancer Clinical Trials

Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Start date: May 31, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications