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Breast Cancer clinical trials

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NCT ID: NCT03237572 Not yet recruiting - Breast Cancer Clinical Trials

Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer

Breast-48
Start date: August 25, 2017
Phase: Phase 1
Study type: Interventional

This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants will be randomized to receive their first dose of pembrolizumab before HIFU.

NCT ID: NCT03235427 Recruiting - Breast Cancer Clinical Trials

The CAROLE (CArdiac Related Oncologic Late Effects) Study

CAROLE
Start date: June 27, 2017
Phase: N/A
Study type: Observational

CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease.

NCT ID: NCT03233334 Recruiting - Breast Cancer Clinical Trials

Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)

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

The Purpose Project intervention is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of women with breast cancer to evaluate the feasibility of the Purpose Project intervention in terms of demand/acceptability, implementation, and limited-efficacy testing. Findings will be used to inform a later study to evaluate the efficacy of the Purpose Project intervention.

NCT ID: NCT03232541 Not yet recruiting - Breast Cancer Clinical Trials

The Effects of Acupuncture and the Therapist´s Communication on Chemo-therapy Induced Nausea and Vomiting

Start date: July 28, 2017
Phase: N/A
Study type: Interventional

Background: Nausea and vomiting (emesis) is a common known problem for patients with cancer who are undergoing chemotherapy. Emesis affects both the patient´s quality of life and induces high costs within the health-care system. Acupuncture is an upcoming treatment for emesis, despite lacking evidence for effects beside non-specific effects since few credibly sham-controlled studies previously have been conducted. The therapist's care and communication during the needling sessions may induce non-specific effects, potentially driven by the patient's expectations. It is not known if the type of communication, in terms of how positive the therapist communicates regarding expected effects, affects the effect of acupuncture for emesis. Aims: The aim of this study is to investigate if chemotherapy-induced nausea, vomiting, and quality of life differ between patients who receive a) standard care including antiemetics, b) standard care plus sham acupuncture or c) standard treatment plus genuine acupuncture. The aim is also to investigate if chemotherapy-induced nausea, vomiting, and quality of life differ between patients who receive the above mentioned standard care, sham acupuncture, or genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the treatment, compared to a therapist who communicates neutral regarding the outcomes. Procedure: The eligible patients will be randomized to A) standard care, including antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication with the therapist during the treatment. Outcome measures: Nausea and vomiting are documented in questionnaires and in a diary, measured with Visual Analogue Scales. Well-being, activity level and quality of life are measured with questionnaires.

NCT ID: NCT03229824 Recruiting - Breast Cancer Clinical Trials

Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial

Start date: October 3, 2016
Phase: N/A
Study type: Interventional

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.

NCT ID: NCT03227328 Not yet recruiting - Breast Cancer Clinical Trials

CHemo-ENDOcrine Therapy in Advanced Breast Cancer

CHENDO
Start date: July 2017
Phase: Phase 3
Study type: Interventional

Prospective, open label, multicenter, randomized phase III study, comparing two strategies as first chemotherapy-based treatment for locally advanced or metastatic luminal breast cancer. - Arm A: concomitant chemotherapy plus an aromatase inhibitor (AI); the AI must continue until disease progression or toxicity or patient refusal; chemotherapy may be stopped after achievement of maximum response (generally after at least about 3-6 months of treatment) or in case of toxicity or patient refusal. - Arm B: chemotherapy followed by an AI at the time of progression to chemotherapy (if an endocrine therapy is deemed indicated by the treating physician) or as maintenance therapy after achieving maximum response to chemotherapy (generally after at least about 3-6 months of treatment) or after stopping chemotherapy for toxicity or patient refusal.

NCT ID: NCT03226782 Completed - Breast Cancer Clinical Trials

Physical Exercise in the Quality of Life and Physical Fitness of Elderly Women With Breast Cancer

Start date: August 15, 2016
Phase: N/A
Study type: Interventional

Among the possibilities of intervention to minimize the effects of cancer treatment, the exercises are efficient in improving the physical fitness and quality of life of the elderly in treatment. The goal is to compare the effects of two home physical exercise protocols on quality of life and physical fitness of elderly people with breast cancer who are in hormone use. A study was carried out at the Institute of Integral Medicine Professor Fernando Figueira (IMIP) within the Professional Master Program in Palliative Care Associated with the Residency Program in Health, which evaluated the effectiveness of a protocol of 29 exercises with walking sessions, performed at home , In the quality of life and physical fitness of the elderly in the treatment of breast cancer. The results of the mentioned research showed that the elderly showed improvement both in quality of life and physical fitness. In view of the results and the clinical and functional kinetic observation of these patients, the hypothesis was that a shorter intervention protocol, with fewer exercises with fewer repetitions and a lower degree of difficulty can bring results similar to those found, requiring a shorter time In the accomplishment of the exercises, which can favor the adherence to the protocol by the patients, still achieving positive results in their quality of life and physical fitness. The elderly will undergo evaluations to characterize the sample through questionnaires, the physical fitness assessment will be performed through the Senior Fitness Test (SFT) and anthropometric evaluation before (beginning of the research), in the 6th week and after the 12th week of the research. It will be offered the elderly, instructional material developed for this research - printed manual. It will consist of a routine of 12 exercises to be performed autonomously for range of motion and muscular fitness, using the environmental resources of the home. All control and training guidelines for using the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises. The control group used a protocol with 29 home exercises in a longer manual. The results will be obtained from the statistical package SPSS 10.0 for Windows and a p <0.05 will be accepted.

NCT ID: NCT03225170 Recruiting - Breast Cancer Clinical Trials

Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling

Start date: August 18, 2017
Phase: N/A
Study type: Interventional

Background: Some women with breast cancer and ovarian cancer are genetically predisposed to them. This is called hereditary breast and ovarian cancer (HBOC). The women have to make hard choices about tests and treatment. Researchers want to study the best way to guide them. A kind of writing exercise might help if it is done before genetic counseling. It is called a self-affirmation (SA) exercise. It may lead to better communication in the counseling and better behavioral outcomes. Objective: To test if an SA exercise done with HBOC genetic counseling could improve client communication and behavior. Eligibility: Adults ages 18-90 with an appointment at the HBOC clinic at St. Luke s Health System Adults ages 18-90 who are genetic counselors with breast and ovarian cancer clients Design: Appointment participants will be screened by phone. They will arrive 15 minutes early to their appointment. They will do a 10- to 15-minute survey and writing exercise. This includes questions about: If they have cancer If they have had or were offered genetic counseling Things that are important to them After the appointment, they will take a 10- to 15-minute follow-up survey. It can be in the office or online. It includes questions about how they felt about the writing exercise and their counseling. Counselor participants will take a 2- to 5-minute survey after sessions with clients in the study. This includes questions about how the client was in the session. They will take a 10- to 15-minute survey at the end of the study. It will be about their opinions of the writing exercise.

NCT ID: NCT03222856 Not yet recruiting - Breast Cancer Clinical Trials

Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes

KELLY
Start date: October 1, 2017
Phase: Phase 2
Study type: Interventional

This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-(HR)positive/HER2-negative metastatic breast cancer (MBC) previously treated with at least one, but not more than two, prior chemotherapeutic regimens for treatment of locally recurrent and/or metastatic disease. Prior therapy must have included an anthracycline and a taxane and prior anti-hormonal therapy is mandatory. The number of patients to be included is 44 patients at 11 sites. All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle.

NCT ID: NCT03221881 Completed - Breast Cancer Clinical Trials

Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer

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

In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.