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Breast Cancer clinical trials

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NCT ID: NCT05259267 Recruiting - Breast Cancer Clinical Trials

Online Group Therapy for Breast Cancer

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

Breast cancer is a serious and life-threatening health problem that is increasing all over the world and in Turkey. Although the survival rate increases with the improvement of the diagnosis and treatment processes for breast cancer, cancer patients experience some psychosocial problems both due to their treatment and the disease. Decreases in quality of life, psychological distress, especially depression and anxiety, post-traumatic stress disorder as well as sleep disorders, fatigue, fear of cancer recurrence could be common negative outcomes that experienced by the breast cancer patients. Although, cancer could be such a life-threatening disease, some patients report that they experience positive changes in their lives after the diagnosis of cancer. The concept of Post-Traumatic Growth (PTG) was first developed by Tedeschi and Calhoun (1995). PTG is a concept that refers positive psychological changes after struggling an stressful life event. According to the Functional-Descriptive model of Tedeschi and Calhoun, post-traumatic growth occurs in five areas; relating to others, personal strength, spiritual changes and appreciation of life. In this context, a group intervention program has been developed for PTG, which will bring the person to a better functionality than before the trauma to enhance the Post-Traumatic Growth level of women with breast cancer. The current research project will consist of three arms; therapy group, support group and wait-list. Online group therapy consists of eight sessions that continue approximately 90 minutes. In addition to an active treatment group for PTG, an online support group has been developed by the researchers to investigate the effectiveness of the therapy. Online support group also consists of eight sessions during approximately 90 minutes as in intervention program. Wait-list is considered as a control group. A set of reliable and validated measurement tools will be administered and heart rate variability as a physical measurement will be used to examine the effects of the therapy. The research hypotheses are based on that patients who participated active treatment group will have better PTG level and other related concept with PTG (like higher score of deliberate rumination) and better Heart-Rate Variability scores than other groups. The researcher will plan to take three time measurement: pre-intervention, post-intervention, and 1-month follw-up.

NCT ID: NCT05258539 Recruiting - Breast Cancer Clinical Trials

Breast Cancer Prevention and Screening Membership

AdDePi_KS
Start date: May 31, 2022
Phase: N/A
Study type: Interventional

The AdDePi-KS project aims to contribute to the renovation of the breast cancer screening program. In order to improve information to women on breast cancer risk factors and their participation in organized screening, but also to reduce the incidence of the disease, the prevention policy currently in place could be adapted and optimized based on the assessment of women's individual risk factors. The current principle of the platform is to offer women a breast cancer risk assessment and prevention consultation with a clinical examination and the use of three breast cancer risk calculation models: Tyrer Cuzick (TC) Mammorisk© (MMR) and CANRISK. In parallel to the use of these three softwares, the Eisinger and Manchester scores are also calculated to evaluate the indication of an oncogenetic consultation. At the end of this analysis, a personalized prevention plan (PPP) proposal, adaptable by the practitioner by shared decision with the consultant, is generated and proposed. The risk assessment and the monitoring strategy are explained to the consultant and when "actionable" risk factors are identified, personalized assistance is proposed (dietary consultation, smoking consultation, distribution of information documents, particularly on physical activity). The objective of this study is to evaluate the impact of the consultation in the long term, in particular on compliance with the recommended monitoring methods and on the "actionable" personal risk factors. For this purpose, investigators propose to set up follow-up questionnaires at 2, 3 and 5 years. These questionnaires will also make it possible to monitor over time how the notion of risk is perceived and how this could influence primary (action on risk factors) and secondary (screening) prevention behaviors. Thus, by accompanying the objectives and methods of prevention in a genuine health democracy process, investigators will be able to identify certain obstacles and levers linked to the implementation of these actions.

NCT ID: NCT05258526 Recruiting - Breast Cancer Clinical Trials

Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)

BENEFIT-CA
Start date: April 7, 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.

NCT ID: NCT05254678 Recruiting - Breast Cancer Clinical Trials

Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy

Empower
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

The primary purpose of this study is to determine the feasibility of our proposed intervention approach involving (1) an integrated physiotherapy and exercise intervention for individuals with breast cancer who are undergoing chemotherapy and (2) delivery of programming via an electronic health (eHealth) application. The secondary objective is to determine the efficacy of the program on upper extremity outcomes, general physical fitness, cancer treatment-related symptoms and quality of life.

NCT ID: NCT05252390 Recruiting - Breast Cancer Clinical Trials

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Start date: March 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

NCT ID: NCT05251714 Recruiting - Breast Cancer Clinical Trials

CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer

Start date: May 27, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of an investigational drug called CFI-402257 alone in advanced solid tumors and in combination with Fulvestrant in advanced breast cancer patients.

NCT ID: NCT05250336 Recruiting - Breast Cancer Clinical Trials

Tumor-Infiltrating Lymphocytes and Programmed Cell Death - Ligand 1 in Breast Cancer

Start date: January 19, 2019
Phase:
Study type: Observational

The morphological evaluation of Tumor-infiltrating Lymphocytes (TILs) in breast cancer is gaining momentum as evidence strengthens for the clinical relevance of this immunological biomarker. In breast cancer (BC) lesions, TILs are seen in intratumoral and stromal areas. TILs are predictive of response to treatment and this association appears to be strongest in Triple-negative (TNBC) and Her 2 (Human epidermal growth factor receptor) positive breast cancer subtypes. Contrastingly, the association in Estrogen Receptor (ER) positive, HER 2 negative tumors have not been established. Programmed cell death 1 (PD-1), are receptors expressed on the surface of T, B, and Natural killer cells and in some tumor cells. These attenuate the cellular immune response by inducing T-cell apoptosis. Programmed Cell Death Ligand 1 (PD-L1) overexpression is reported to be associated with large tumor size, lymph node metastasis, and ER-negativity. Importantly, PD-L1 is expressed more frequently in TNBC patients. High PD-L1 expression may be a prognostic indicator for reduced overall survival6. This information may be helpful to screen candidates for anti-PD-1/PD-L1 therapy, especially patients with TNBC The aim of this study is to characterize the cohort of patients with breast cancer based on a semiquantitative assessment of TILs and to correlate the concentration of TILs and PD-L1 in various intrinsic subtypes (based on Immunohistochemistry) with the overall outcome. Also to correlate the TILs and PD-L1 expression with tumor response to Neoadjuvant Chemotherapy (NACT) and to stratify the predictive value of this biomarker in TNBC.

NCT ID: NCT05246592 Recruiting - Clinical trials for Breast Cancer Lymphedema

Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

PLEDGE-R
Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).

NCT ID: NCT05245812 Recruiting - Breast Cancer Clinical Trials

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Start date: March 8, 2022
Phase: N/A
Study type: Interventional

This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer. Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.

NCT ID: NCT05243641 Recruiting - Breast Cancer Clinical Trials

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Start date: August 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to learn if the combination therapy of capmatinib and neritinib can help to control metastatic or locally advanced breast cancer. Researchers also want to find the highest tolerable dose of the combination therapy of capmatinib and neritinib that can be used in this study drug combinations. The safety of this drug combination and the CELsignia MP test methodology will also be studied.