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Breast Cancer clinical trials

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NCT ID: NCT04474652 Suspended - Breast Cancer Clinical Trials

Guide for Prioritisation of Patients for Referral to Breast Clinics

Start date: February 12, 2020
Phase:
Study type: Observational

GPs in primary care in England currently refer over 2.17 million patients per year with vague symptoms to the urgent cancer referral pathway. While this catches over 150,000 cancer cases each year, 93% of the referred patients do not have cancer. For breast cancer, GPs refer 343,000 cases per year. Each of these patients are referred to a one stop clinic for diagnosis. The Leeds teaching Hospitals' Trusts' Breast Unit, receives 10,000 per year, with only 5% of patients actually being diagnosed with cancer. The breast cancer pathway involves a triple assessment process, which includes a clinical examination, imaging (mammogram or ultrasound) and possibly a biopsy test. It is a particularly expensive process as it is an imagingintense pathway; this places considerable strain on NHS diagnostic facilities. Small changes will not be enough to solve this problem - a new approach is needed. The purpose of this study is to see if we can develop a blood test that can support doctors in identifying patients for whom the likelihood of having breast cancer is extremely low. This would avoid unnecessary referral for those patients to the one stop clinic. Patients with higher chances of suspected breast cancer would be referred to the one stop clinic in the usual way. Key to the idea of safely "ruling-out" patients is that the test must not miss patients who do have cancer. By measuring a broad range of indicators (markers) in blood, the test will provide a more accurate picture of the underlying biology. The test is also being developed within the NHS, so that it can be adopted quickly into NHS computer systems and laboratories to maximise patient benefit, whilst being held to the NHS's high standards for clinical evidence and value.

NCT ID: NCT04434040 Suspended - Breast Cancer Clinical Trials

Ipatasertib + Atezolizumab to Prevent Recurrence in TNBC

Start date: July 2, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if a combination of two drugs ipatasertib and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: - Ipatasertib - Atezolizumab

NCT ID: NCT04293874 Suspended - Breast Cancer Clinical Trials

Adaptive Symptom Care Using Fish-Based Nutritional Directives Post Breast Cancer

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

Inflammation has been consistently associated with psychoneurological symptoms (PNS) among breast cancer survivors (BCS). Evidence supporting interventional strategies promoting symptom-self management in reducing inflammation-induced PNS in BCS is limited. Current guidelines for BCS encourage the consumption of foods rich in omega-3 fatty acids. The omega-3 fatty acid docosahexaenoic acid (DHA), abundantly available in fish, has a role in inflammatory downregulation. Low dietary DHA has been associated with inflammation and fatigue in BCS. Dietary planning targeting increased fish consumption thereby reducing red and processed meats are components of the major nutritional recommendations for BCS. A critical gap exists in knowledge regarding interventions promoting adherence to dietary guidelines in BCS supporting PNS self-management. This investigation uses personalized meal planning among BCSs (n=150) who are 1-2 years post-treatment for early-stage breast cancer and experiencing PNS (pain, fatigue, depression, sleep disturbance, stress) to evaluate the feasibility of a personalized meal planning approach in supporting adherence to current dietary guidelines for BCS. As a first step in this program of research, we will evaluate the feasibility of an personalized meal planning approach in promoting adherence to dietary guidelines for BCS through evaluating the feasibility of a personalized meal planning approach in a cohort of BCSs with respect to recruitment, group allocation, salivary inflammatory quantification and receptivity to and adherence with dietary interventions. This investigation will also contribute to a preliminarily evaluation of the efficacy of high or low fish diet in reducing inflammation (IL-1β, IL-6, TNF-a) and PNS symptoms. Nationally, there is a priority for the development of personalized health strategies supporting self-management of adverse symptoms. This investigation focused on PNS in BCS is an initial step in generating new knowledge in efficacious approaches toward guiding decisions on dietary behavior change strategies that are personalized, cost-effective, and sustainable.

NCT ID: NCT04292847 Suspended - Breast Cancer Clinical Trials

LCCC1931:Post-treatment Intervention in Women With Breast Cancer (70y/o+)

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

This study recruits woman over the age of 70 who have completed primary treatment for early breast cancer in the last 2 months. A survey called the geriatric assessment will be used to identify symptoms and issues participants experience.This information will be given to the patient's medical oncology team, and used to make referrals to specialists. This study is designed to determine if these assessments and timely interventions can be completed during clinic visits, and determine if these participants comply with recommendations.

NCT ID: NCT04267315 Suspended - Breast Cancer Clinical Trials

Trigger Point Injections for Post-Mastectomy Pain Syndrome

Start date: January 3, 2020
Phase: Phase 2
Study type: Interventional

Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain, an specific type of muscular pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other painful conditions. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS. The intervention objective is to assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.

NCT ID: NCT04102436 Suspended - Breast Cancer Clinical Trials

Non-Viral TCR Gene Therapy

Start date: May 7, 2021
Phase: Phase 2
Study type: Interventional

Background: A person s white blood cells can be modified in a lab to recognize certain changes in their tumor. Many of these cells are collected from the person, modified, then given back to the person. This may help treat some cancers. Objective: To learn if a person s white blood cells modified with T-cell receptors can cause solid tumors to shrink. Eligibility: People ages 18-70 who have cancer of the gastrointestinal tract, genitourinary tract, ovary, breast, or lung that has spread, or who have glioblastoma. Design: Participants will be screened and have their cells prepared for treatment in another protocol. Participants will be hospitalized one week before treatment. They will stay approximately 3 - 4 weeks after treatment. Participants will get the modified white blood cells and chemotherapy through an IV catheter, which is a small plastic tube inserted in a vein. Participants will take drugs by mouth to prevent infection. They will receive filgrastim as a shot or injection under the skin. Participants will have tests before, during, and after treatment: Heart, blood, and urine tests Chest X-ray Physical exam Scans: They will lie in a machine that takes pictures of the body. Possible apheresis: The participant s blood is removed through a needle in an arm. The blood goes through a machine that removes the white blood cells. The rest of the blood is returned through a needle in the other arm. Participants will have visits about 6 and 12 weeks after treatment. If they are responding to treatment, they will then have visits every 3-6 months for 3 years. Then they will join another study and be followed about 12 more years.

NCT ID: NCT03936478 Suspended - Breast Cancer Clinical Trials

Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

MAPBI
Start date: May 2021
Phase: Phase 2
Study type: Interventional

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.

NCT ID: NCT03845907 Suspended - Breast Cancer Clinical Trials

Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Start date: December 19, 2018
Phase: N/A
Study type: Interventional

Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects

NCT ID: NCT03630809 Suspended - Breast Cancer Clinical Trials

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

Start date: January 10, 2019
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: NCT03574194 Suspended - Breast Cancer Clinical Trials

Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy

Start date: June 12, 2018
Phase: N/A
Study type: Interventional

A diet consisting of a reduced quantity of the essential amino acid methionine sensitizes cancer cells to radiation therapy and reduces metastasis formation and disease progression in mice. However, to date, dietary restriction of methionine has not been tested in combination with radiation therapy in humans as a strategy to improve patient outcomes.