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Breast Cancer clinical trials

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NCT ID: NCT03437161 Completed - Breast Cancer Clinical Trials

A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

Start date: January 17, 2017
Phase: N/A
Study type: Interventional

This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

NCT ID: NCT03433560 Completed - Clinical trials for Breast Cancer Female

An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)

Start date: January 18, 2018
Phase:
Study type: Observational

The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects. Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia. Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%

NCT ID: NCT03433313 Completed - Breast Cancer Clinical Trials

Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer

Start date: October 16, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12 months.

NCT ID: NCT03432429 Completed - Breast Cancer Clinical Trials

Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study

REI-EXCISE
Start date: September 5, 2017
Phase:
Study type: Observational

REI-EXCISE is a multicentre, prospective, non-randomised feasibility study, aimed to evaluate the diagnostic accuracy of rapid ionisation mass spectroscopy using an iKnife device. The iKnife will collect vapour, a by-product of surgery, which will pass through the mass spectrometer machine for analysis in order to evaluate what is "normal" and what is "cancerous" breast tissue.

NCT ID: NCT03430765 Completed - Clinical trials for Breast Cancer Female

Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy

Start date: June 21, 2015
Phase: N/A
Study type: Interventional

The proposed study will be a pilot randomized controlled trial comparing treatment as usual (TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention (TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing persistent post-operative pain. The ACT intervention is a single individual therapy session scheduled two weeks following surgery. Potential participants will be recruited from the University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the study is 72 participants. Study measures will consist of self-report questionnaires and medical record data. Data will be collected prior to surgery, one-week after surgery, and 3 months after surgery.

NCT ID: NCT03430479 Completed - Breast Cancer Clinical Trials

Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer

Start date: June 22, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.

NCT ID: NCT03429296 Completed - Breast Cancer Clinical Trials

Autohypnosis and Cancerology

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient. Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy. In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy. The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management. The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.

NCT ID: NCT03428789 Completed - Breast Cancer Clinical Trials

Nerve Coaptation in DIEP Flap Breast Reconstruction

Start date: September 2015
Phase: N/A
Study type: Observational

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated DIEP flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between September 2015 and July 2017. Semmes-Weinstein monofilaments were used for sensory testing of the breast. This study showed that nerve coaptation in DIEP flap breast reconstruction resulted in a significantly improved sensation of the reconstructed breast compared to non-innervated flaps.

NCT ID: NCT03428399 Completed - Breast Cancer Clinical Trials

Depression and Body Image Distress Following Mastectomy With Reconstruction

Start date: October 12, 2017
Phase:
Study type: Observational

Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.

NCT ID: NCT03427450 Completed - Healthy Volunteers Clinical Trials

Harvest of CTCs From MBC Patients Using the Parsortix™ PC1 System

HOMING
Start date: March 29, 2018
Phase:
Study type: Observational

The purpose of this clinical study is to demonstrate that the Parsortix™ PC1 system enables the capture and harvest of circulating tumor cells (CTCs) from the peripheral blood of patients with metastatic breast cancer (MBC) and not from healthy volunteers (HVs). The study is also designed to demonstrate that the CTCs harvested by the Parsortix PC1 system from MBC patients can be used effectively for different types of evaluations (e.g. cytopathology, FISH, qPCR, RNAseq, etc.). This is an investigational study. The Parsortix PC1 system is not FDA approved and is currently being used for research purposes only.