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Breast Neoplasms clinical trials

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NCT ID: NCT05095675 Recruiting - Breast Cancer Clinical Trials

Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back

BOUNCE
Start date: December 6, 2018
Phase:
Study type: Observational

Breast cancer accounts for 28% of all cancer cases in Europe ("WHO," 2018). Coping with breast cancer is becoming an increasingly burdensome socio-economic challenge, partly due to the increasing incidence registered in the last years, which is occurring despite continuous advances in medicine. This said, mortality rate has decreased significantly as 5-year survival rate has risen from 75% to 90% ("Breast Cancer Research Foundation," 2016). For these reasons the number of cancer survivors has grown, with important effects on quality of life even years after the end of treatments. The process of successful adaptation to breast cancer and the various accompanying stressors can be conceptually defined as the person's resilience. Resilience is a complex construct that can be defined on different levels: an individual's potential (capacity to engage in adaptive coping processes), a process (adaptive reactions to adversity), and an outcome (the final state achieved as the result of coping). While theoretical contributions regarding resilience models in medical settings have been advanced (Deshields et al., 2016), to date no one has tested the integrated contributing role of multiple psychological, biological and functional variables in predicting the patient's ability to bounce back from the stressful life event of being diagnosed with breast cancer. Resilience is going to be measured through a data-driven method (computation of resilience index on the basis of retrospective data) and through a psychometric method (various domains of resilience through questionnaires). There is a growing need for novel strategies to improve the understanding and the capacity to predict resilience of women to the variety of stressful experiences. BOUNCE European Project (H2020 European Project "Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back"; Grant Agreement Nr: 777167) will bring together modelling, medical, and social sciences experts to advance current knowledge on the dynamic nature of resilience as it relates to improved quality of life. The broad and general objective of the BOUNCE project is to build a quantitative mathematical model of factors associated with optimal adjustment capacity to cancer. The investigators will collect biomedical status (BMS), the psychosocial status (PSS) and the functional status (FUS) of breast cancer patients that literature demonstrated to be predictive of patients' capacity to bounce back during the highly stressful treatment and recovery period following diagnosis of breast cancer. The overarching goal of the model is to understand which factors predict optimal adjustment to breast cancer and which combination of factors undermine adjustment. This would allow early identification of women at risk for which it is better to intervene through a personalised psychological support. Funding: The BOUNCE Project "Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back" has received funding from the European Union's Horizon 2020 research and innovation programme, Project type: H2020 - SCI-2017-CNECT-2; Project type: H2020 - SCI-2017-CNECT-2; Grant Agreement Nr: 777167.

NCT ID: NCT05095207 Recruiting - Breast Cancer Clinical Trials

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Start date: September 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

NCT ID: NCT05094310 Recruiting - Breast Cancer Clinical Trials

Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Genetic predictors of response to acupuncture for cancer-related fatigue among breast cancer patients after chemotherapy.

NCT ID: NCT05094102 Completed - Breast Cancer Clinical Trials

Intraoperative Evaluation of Axillary Lymphatics

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

This study will assess the feasibility of using the OnLume Imaging System for fluorescence-guided surgery along with indocyanine green (ICG) dye in the operating room for the axillary reverse mapping (ARM) procedure in women with breast cancer scheduled to have axillary dissection (AD) or sentinel lymph node (SLN) biopsy.

NCT ID: NCT05093426 Completed - Breast Cancer Clinical Trials

PERSONAL - Sleep In Breast Cancer

Start date: January 15, 2022
Phase:
Study type: Observational

Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures. In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems.

NCT ID: NCT05093387 Withdrawn - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

SGT-53, Carboplatin, and Pembrolizumab for the Treatment of Metastatic Triple Negative Inflammatory Breast Cancer

Start date: November 10, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial studies the effect of SGT-53, carboplatin, and pembrolizumab in treating patients with triple negative inflammatory breast that has spread to other parts of the body (metastatic). SGT-53 is a gene therapy that changes the deoxyribonucleic acid (DNA) of patients' tumor cells to make it easier for the immune system to recognize them. SGT-53 targets the TP53 gene, which is frequently mutated in IBC cells. Chemotherapy drugs, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SGT-53, pembrolizumab, and carboplatin may help the control the disease in patients with triple negative inflammatory breast cancer.

NCT ID: NCT05093023 Completed - Breast Cancer Clinical Trials

ABCB1 SNPs as Predictors of PIPN

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

The study aim is to determine the allele frequencies of 1236 G>A and 3435 G>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.

NCT ID: NCT05092477 Completed - Breast Cancer Clinical Trials

Integrated Intervention for Breast Cancer Survivors With Diabetes

BRIDGES
Start date: January 27, 2022
Phase: N/A
Study type: Interventional

The purpose of this research study is to learn how therapy for breast cancer or DCIS/LCIS affects cognitive function and beliefs about cancer/DCIS/LCIS and diabetes (DM). For this portion of the study, the study team will integrate the information collected at previous follow-ups to create educational modules to change disease and medication beliefs and improve DM self-management behaviors (SMB). The educational counseling modules the study team plans to pilot test are rooted in the Common Sense Self-Regulation Model, a theory that posits that health behaviors are influenced by two parallel processes: cognitive (i.e., disease beliefs and expectations) and affective (i.e., emotional responses).

NCT ID: NCT05092373 Recruiting - Clinical trials for Malignant Solid Neoplasm

Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax

Start date: April 29, 2022
Phase: Phase 1
Study type: Interventional

This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.

NCT ID: NCT05090605 Completed - Breast Cancer Clinical Trials

The Role of Genetic Factors in the Development of Breast Cancer in the Kazakh Population

Start date: March 30, 2022
Phase:
Study type: Observational

This is a GWAS study that aims to identify possible candidate genes associate to breast cancer by exploring single nucleotide polymorphism (SNP) in a group of breast cancer, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with breast cancer