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Breast Cancer clinical trials

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NCT ID: NCT03632941 Not yet recruiting - Breast Cancer Clinical Trials

A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer

Start date: October 2018
Phase: Phase 2
Study type: Interventional

In this phase II study, study subjects will receive the VRP-HER2 immunizations plus pembrolizumab. There will be an initial Safety Arm during which subjects will receive the VRP-HER2 immunizations plus pembrolizumab. If there is no dose limiting toxicity in the Safety Arm, then subjects will be randomized into 3 arms. They will undergo a biopsy of their tumor and peripheral blood draw for immune cell analyses and be assigned to the applicable arm of the study. Arm A will consist of the the VRP-HER2 immunizations; Arm B will consist of pembrolizumab; Arm C will consist of the VRP-HER2 immunizations plus pembrolizumab.

NCT ID: NCT03631758 Not yet recruiting - Breast Cancer Clinical Trials

Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.

NCT ID: NCT03630809 Not yet recruiting - Breast Cancer Clinical Trials

Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1

Start date: October 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-directed dendritic cells (DC) vaccines. There is evidence that the use of anti-HER2 dendritic cell (DC) study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence. This study will use a Dendritic Cell Type 1 (DC1) vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. Dendritic cells are immune cells that can tell the participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.

NCT ID: NCT03630354 Not yet recruiting - Breast Cancer Clinical Trials

EXERCISING TOGETHER© for Couples Coping With Cancer

Start date: August 2018
Phase: N/A
Study type: Interventional

The Exercising Together trial is a single-blind, parallel group, randomized controlled trial comparing 3 arms: Arm 1 (experimental): Exercising Together where couples perform partnered exercise in a supervised, group setting versus two comparator conditions where survivors and spouses perform exercise routines separately in either a supervised group setting (Arm 2) or unsupervised at home (Arm 3). All three arms will train for a 6-month period and then be followed 6 months later. Data will be collected at baseline, 3, 6 and 12 months.

NCT ID: NCT03628066 Not yet recruiting - Breast Cancer Clinical Trials

Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

Start date: September 15, 2018
Phase: Phase 2
Study type: Interventional

This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.

NCT ID: NCT03627442 Not yet recruiting - Breast Cancer Clinical Trials

Post-op Outcomes of Enhanced Energy Delivery Dissection for Mastectomy With Immediate Breast Reconstruction

Start date: August 15, 2018
Phase: N/A
Study type: Interventional

Principal Investigator: Sheldon Feldman, MD Co-Principal Investigator: Mohamad Sebai, MD Department of Surgery, Montefiore Medical Center - Einstein College of Medicine Title Pilot Study: Post-operative outcomes of enhanced energy delivery dissection for mastectomy breast flap creation with immediate breast reconstruction Goal Determine the feasibility of a study design that includes the evaluation of breast flap viability, postoperative surgical site drainage, post-operative pain/surgical site complications, time to complete mastectomy with Photonblade (PB) vs traditional electrosurgery devices. Overall outcome If determined feasible, consider going to clinical trial. Timing 6 months starting after execution of contract Study population Women between 18-65 years old Choose bilateral mastectomy followed by immediate breast reconstruction (through tissue expander insertion) No inflammatory breast cancer/no radiotherapy Study design Single blinded, randomized controlled pilot study (n=15) Only breast surgeon knows which device was used for each breast Study feasibility endpoints Flap Viability - compare perfusion, using PhotonVue, of flaps creation using PB vs Bovie (left is better, right is better or they are similar) Site drainage - Measure drainage volume and duration Pain scores and complications - Subjective pain assessment on days 1, 2, 3, 7 and 30 post-op. (Pain visual Analog Scale). Surgical site complications will be recorded up to 30-days post-op. Time to completion of mastectomy flap using PB vs Bovie will be recorded. (Time in minutes between initial incision and completion of mastectomy for each side) Analysis Descriptive analysis will be performed to examine data distribution, missing data and data errors. Continuous variables will be summarized using means or medians; categorical variables will be summarized using proportions. CLINICAL TRIAL Objectives Determine if post-op flap viability differs between women getting mastectomy flap creation using PB vs Bovie Determine if post-op site drainage measures differs between two devices Determine if post-op pain measures differ when using PB vs Bovie Determine if time to mastectomy flap creation differs between using Bovie and PB

NCT ID: NCT03624543 Not yet recruiting - Breast Cancer Clinical Trials

CFI-400945 in Patients With Advanced/Metastatic Breast Cancer

Start date: August 30, 2018
Phase: Phase 2
Study type: Interventional

The standard or usual treatment for this disease is to undergo chemotherapy to slow the spread of the disease and relieve some symptoms of cancer. Patients will have already had at least one chemotherapy treatment for their disease at this stage.

NCT ID: NCT03619681 Not yet recruiting - Breast Cancer Clinical Trials

Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer

Start date: August 31, 2018
Phase: Phase 1
Study type: Interventional

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 4 proposed dose levels which are 5, 10, 15, and 20 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached.

NCT ID: NCT03618433 Not yet recruiting - Breast Cancer Clinical Trials

KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery

Start date: September 2018
Phase: N/A
Study type: Interventional

The main objective of the study is to investigate the effects of Kinect® video based technology on pain, functionality, muscle strength, fatigue and quality of life in patients with breast cancer surgery and axillary node dissection.

NCT ID: NCT03616457 Not yet recruiting - Breast Cancer Clinical Trials

Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis

AMELIA
Start date: August 2018
Phase:
Study type: Observational

The purpose of this study is to assess whether the Invenia™ Automated Breast Ultrasound (ABUS) device, as an adjunct to Digital Breast Tomosynthesis (DBT), improves breast cancer detection in women with dense breasts. The study aims to collect information about cancer detection, treatment, and outcomes based on individual and combined technologies in patients who receive ABUS exams in addition to DBT. The results of this study are intended to be used to extend understanding of ABUS as an adjunct in DBT screening in patients with dense breasts.