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Breast Neoplasms clinical trials

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NCT ID: NCT03198286 Completed - Clinical trials for Stage IIIA Breast Cancer

Carevive Survivor Care Planning System in Improving Quality of Life in Breast Cancer Survivors

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

This pilot clinical trial studies how well the Carevive Survivor Care Planning System works in improving quality of life in breast cancer survivors. A personalized survivor care plan includes a summary of a patient's cancer treatment and a customized survivor care plan and may provide beneficial information and resources.

NCT ID: NCT03197935 Completed - Clinical trials for Triple-negative Breast Cancer

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

IMpassion031
Start date: July 24, 2017
Phase: Phase 3
Study type: Interventional

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

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: NCT03196037 Completed - Clinical trials for Cognitive Impairment

Feasibility of an 8-week Tai Chi Chuan Intervention for Breast Cancer Survivors

Start date: December 5, 2017
Phase: N/A
Study type: Interventional

Purpose:To gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive performance, health-related quality of life, brain activity, and blood-based biomarkers. Participants: Adult survivors (> 18 years old) who report experiencing cognitive impairment and are within 60 months of completion of chemotherapy for treatment of a breast cancer diagnosis. Procedures (methods): A single arm pre-/post-test non-randomized study design in adult cancer survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60 months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and consist of feasibility, acceptability, expectancy/credibility, health-related quality of life, cognitive performance, serum biomarkers, and brain activity.

NCT ID: NCT03195192 Completed - Clinical trials for Metastatic Breast Cancer

Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer

Start date: March 9, 2017
Phase: N/A
Study type: Interventional

This is an open-label, multicenter study in patients with metastatic breast cancer who are candidates for standard first line treatment with palbociclib or ribociclib plus endocrine therapy. To be eligible, patients must have received no prior chemotherapeutic or hormonal regimen for metastatic disease. However, patients may still be considered eligible if they have already started treatment with endocrine therapy (an aromatase inhibitor or fulvestrant) plus palbociclib or ribociclib for no longer than 4 weeks prior to study enrollment, as long as they meet all other eligibility criteria. Eligible patients must have had a diagnostic biopsy of the metastatic lesion no more than 4 months prior to study enrollment and with sufficient tissue to complete the proposed biomarker analysis. Patients who develop disease progression within the first 12 months of starting palbociclib or ribociclib plus endocrine therapy will be eligible for an optional additional tissue biopsy at time of disease progression to repeat the analysis at time of disease progression and obtain real-time (10-14-day turn-around) multi-omic data produced under College of American Pathologist (CAP)/Clinical Laboratory Improvement Amendments (CLIA) development and/or compliant practices.

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: NCT03193853 Completed - Clinical trials for Triple Negative Breast Cancer

TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer

Start date: July 18, 2017
Phase: Phase 2
Study type: Interventional

This study evaluates efficacy of TAK- 228 and TAK- 117 followed by cisplatin and nab paclitaxel in patients with metastatic triple negative breast cancer.

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.

NCT ID: NCT03190083 Completed - Breast Cancer Clinical Trials

Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer

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

The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.