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Breast Cancer clinical trials

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NCT ID: NCT03524248 Terminated - 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: NCT03480659 Terminated - Breast Cancer Clinical Trials

Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

Start date: June 1, 2018
Phase:
Study type: Observational

A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in breast cancer patients.

NCT ID: NCT03456661 Terminated - Breast Cancer Clinical Trials

Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block

Start date: May 19, 2014
Phase: Phase 4
Study type: Interventional

A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure. The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups . The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.

NCT ID: NCT03448250 Terminated - Breast Cancer Clinical Trials

Evaluating a Novel Web-based Intervention for Breast Cancer Survivors

OPTIMUNE
Start date: March 16, 2018
Phase: N/A
Study type: Interventional

The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast cancer who are past the active eradication phase and free from disease recurrence. The present study will test the hypothesis that Optimune has an impact on immune status, markers of inflammation and psychometric outcomes. Therefore, 150 woman with breast cancer will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU) and receive access to Optimune after a delay of 6 months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives 12-month access to Optimune and may also use CAU. The primary outcome measure is the effect on inflammatory parameters six month post-baseline.

NCT ID: NCT03430466 Terminated - Breast Cancer Clinical Trials

Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer

Start date: June 22, 2017
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.

NCT ID: NCT03429101 Terminated - Breast Cancer Clinical Trials

A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

Start date: July 13, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.

NCT ID: NCT03422679 Terminated - Breast Cancer Clinical Trials

Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies

Start date: December 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.

NCT ID: NCT03417024 Terminated - Breast Cancer Clinical Trials

Automated Breast Ultrasound Case Collection Registry

Start date: July 12, 2018
Phase:
Study type: Observational [Patient Registry]

The contribution of automated breast ultrasound (ABUS) to the screening pathway for breast cancer is not fully understood. This prospective study aims to collect longitudinal data in women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis (DBT). The data are intended for use in future research on the value and effectiveness of ABUS in routine clinical care. Data will be collected from eligible women who have been prescribed or have completed DBT and ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast cancer status and results of any diagnostic breast exams and/or treatment.

NCT ID: NCT03407430 Terminated - Breast Cancer Clinical Trials

Trial of Pregabalin for Granulocyte Colony-stimulating Factor (GCSF)-Induced Bone Pain

Start date: January 27, 2016
Phase: Phase 2
Study type: Interventional

Purpose: To evaluate the preventative effects of pregabalin on pegfilgrastim-induced bone pain in cycle 1. Because granulocyte colony stimulating factor (G-CSF) receptors are found at nerve endings which modulate the pain signal, blocking this with pregabalin is theorized to prevent the occurrence of this adverse effect. Participants: Patients will be at least 18 years of age with either a diagnosis of a non-myeloid hematologic malignancy scheduled to initiate a cycle of chemotherapy that requires prophylactic use of a G-CSF, or with a diagnosis of breast cancer scheduled to initiate dose-dense doxorubicin/cyclophosphamide chemotherapy or docetaxel/cyclophosphamide that requires prophylactic use of a G-CSF. Procedures (methods): This is a randomized (1:1), single center, placebo-controlled, double blind, crossover phase II study. The primary objective is to compare the proportion of patients who have an increase in pain score of ≥3 from baseline in cycle 1 between Arm A (pregabalin) and Arm B (placebo). In consultation with the treating physician, the PI will determine what day pegfilgrastim will be initiated in each eligible, consented patient. Pregabalin or placebo will begin 4 days prior to pegfilgrastim administration, and continue for 7 additional days starting the day of pegfilgrastim administration.

NCT ID: NCT03407040 Terminated - Breast Cancer Clinical Trials

Generation of Cancer Antigen-Specific T-cells From Human Induced Pluripotent Stem Cells (iPSC) for Research and Potential FutureTherapy

Start date: January 30, 2018
Phase:
Study type: Observational

Background: Researchers want to test if certain cells can be re-programmed into stem cells. Stem cells can keep reproducing for a long time. Cells made by stem cells can be turned into different types of cells. These include cancer-fighting cells, skin cells, etc. The stem cells generated in this study will be used to make specific tumor-fighting cells that can recognize different types of mutations in cancer cells. They may also help identify new tumor mutations that may not have been identified yet. Objectives: To test if a certain type of tumor-fighting cells can be re-programmed into stem cells. Eligibility: Participants in another Surgery Branch protocol who are at least 16 years old Design: Participants already gave samples of blood and/or tumor tissue in the other protocol. They do not need to come back to the clinic or give any other samples. Participants will give consent for their samples to be used in this study. Researchers will obtain cells from the samples. They will grow those cells in the lab. They will create stem cells from them. Researchers will do genetic tests on the samples. Most tests will not show important health results. But if they do, the participant will be invited to talk to a genetic counselor and get more detailed testing to confirm the results. Some of the samples and results will be stored indefinitely. They may be used in future research. No personal information will be stored with them. ...