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Breast Neoplasms clinical trials

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NCT ID: NCT03475992 Completed - Breast Cancer Clinical Trials

Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.

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

The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation. Microwave imaging is an emerging imaging modality for the early detection of the breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at microwave frequencies. Microwave imaging can potentially be used for monitoring neoadjuvant chemotherapy treatment, breast health monitoring, and for routine screening and diagnosis of the breast cancer at the early-stage. The non-invasive and the non-ionizing characteristics of microwaves should allow for frequent scans of the breast using microwave imaging, unlike X-ray mammography. In addition to safety, microwave imaging does not require uncomfortable breast compression and it is potentially a lower-cost modality. This is a first-in-human clinical test of the investigational device, which has been so far tested only with experimental phantoms modelling the human female breast. The clinical data that will be collected in the context of this study is intended to provide early safety information for the investigational medical imaging device. In addition, this exploratory data will guide the refinement of the device hardware and the imaging algorithm design, before decision to proceed (or not) with further clinical tests. Furthermore, this study will be used to guide sample size calculation for a subsequent study designed to evaluate efficacy should that appear warranted once this study is completed.

NCT ID: NCT03475433 Completed - Clinical trials for Neoplasm of Breast (Disorder)

An Observational Prospective Cohort Study Using an Actigraphy Device.

Start date: May 15, 2018
Phase:
Study type: Observational

This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device. This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique Identification number (ID), which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.

NCT ID: NCT03473639 Completed - Breast Cancer Clinical Trials

A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

Breast49
Start date: January 29, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the safety and side effects of combining entinostat, an investigational drug, with capecitabine, a drug commonly used in breast cancer (BC), in both participants with metastatic breast cancer (MBC) and then participants with high-risk breast cancer after neo-adjuvant therapy.

NCT ID: NCT03472794 Completed - Breast Cancer Clinical Trials

Adaptation of a Knowledges Exchange Portal Between (KEP) Healers and Patients : Obstacles and Sources to KEP Use for Breast Cancer Women

Sav-AQ
Start date: March 16, 2018
Phase:
Study type: Observational

The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context

NCT ID: NCT03471741 Completed - Breast Cancer Clinical Trials

Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

Start date: June 1, 2001
Phase:
Study type: Observational

To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

NCT ID: NCT03471663 Completed - Breast Cancer Clinical Trials

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

Start date: March 18, 2018
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

NCT ID: NCT03471494 Completed - Gastric Cancer Clinical Trials

GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

GS3
Start date: April 1, 2018
Phase:
Study type: Observational

Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication rates after cancer surgery. The secondary aim is to characterise infrastructure and care processes in the treatment of these cancers worldwide. Primary outcome measure 30-day mortality and complication rates after cancer surgery. Primary comparison Between country groups defined by human development index. Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer. Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent. Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged. Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018). Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.

NCT ID: NCT03470935 Completed - Clinical trials for Breast Cancer Female

Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger

ARTEMIS
Start date: September 15, 2017
Phase:
Study type: Observational

Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40. The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1). The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today. The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists. Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity. At the time of diagnosis, almost 50% of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancy(s). The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially responsible for subsequent fertility disorders. In addition, a chemotherapy-induced amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is sometines definitive and sequellar of treatment. However, few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility. The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question, on the recovery of menstrual cycles and the quality of sexual life of these patients. The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility, to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life. These results could help to sensitize the doctors to the difficulties encountered by young women and to improve and/or to strengthen the global and adapted care of these patients.

NCT ID: NCT03465813 Completed - Breast Cancer Clinical Trials

Reducing Distress and Depressive-symptoms in Rural Women

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

Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. For rural cancer survivors, lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. However, these barriers may be overcome by a new Internet-based psychoeducational program designed for newly diagnosed women; CaringGuidanceâ„¢- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding and provide supportive tools to prevent/manage distress and depressive-symptoms. This pilot study will determine preliminary efficacy of the CaringGuidanceâ„¢ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer.

NCT ID: NCT03464942 Completed - Breast Cancer Clinical Trials

Stereotactic Radiation and Immunotherapy in Patients With Advanced Triple Negative Breast Cancer

AZTEC
Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

This is a multi-centre, open label, phase 2, randomised controlled trial of patients with advanced triple negative breast cancer (TNBC) who have received no more than one line of chemotherapy (not including neoadjuvant or adjuvant therapy) who will be randomised to be treated with SABR 20Gy in 1# followed by atezolizumab or SABR 24Gy in 3# followed by atezolizumab.