The Journey of Women With Breast Cancer in Mozambique: What is the Best Path? A Prospective Cohort With Patient Navigation as an Intervention to Reduce Treatment Disparities
The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows: - Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment? - Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.
NCT06257888 — Breast Neoplasm Malignant Primary
Status: Not yet recruiting
http://inclinicaltrials.com/breast-neoplasm-malignant-primary/NCT06257888/
An Open-label, Single-arm Study of Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer
This is an open-label, single-arm, exploratory study planned to include 40 patients with HRD-positive HR +/HER2- advanced breast cancer treated with Adebrelimab in combination with fluzoparib. To observe and evaluate the efficacy and safety of Adebrelimab combined with fluzoparib in the treatment of HRD-positive HR +/HER2-advanced breast cancer
NCT06254066 — Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/histopathologically-confirmed-advanced-hr-her2-invasive-breast-cancer/NCT06254066/
Cardiac Rehabilitation for Breast Cancer Survivors at Risk for Cardiovascular Disease Secondary to Cardiotoxic Treatment
Women with breast cancer treated using anthracyclines and/or trastuzumab are at an increased risk of cardiovascular disease (CVD) following treatment completion. Exercise is known to reduce CVD risk in healthy and several clinical populations, but, whether existing cardiac rehabilitation programs can be leveraged to reduce CVD risk in breast cancer survivors is unknown. This study aims to: i) understand the feasibility of virtual versus in-person cardiac rehabilitation in breast cancer survivors; and ii) compare the effect of virtual versus in-person cardiac rehabilitation on cardiovascular function and injury biomarkers, physical fitness, and psychosocial health. 50 breast cancer survivors with increased CVD risk will be recruited and randomized to either the in-person or virtual arm of the cardiac rehabilitation program at Women's College Hospital (WCH). Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility. Other clinically relevant outcomes to be collected include: i) imaging and blood-based biomarkers of cardiovascular function; ii) physical fitness; iii) objective and self-reported physical activity levels; and iv) self-reported measures of psychosocial wellbeing. These findings will be used to inform the design of a larger-scale cardio-oncology trial and will facilitate development of more comprehensive CVD risk management strategies for breast cancer survivors at WCH.
NCT06251401 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06251401/
The Effects of a Nurse-led Using Wearable Technology Physical Activity Program on Health-Related Quality of Life and Physical Activity Level Among Breast Cancer Survivors
A nurse-led physical activity program including an individualized exercise program using wearable technology and health coaching based on Social Cognitive Theory will be implemented for women surviving cancer. The impact of the nurse-led physical activity program on physical activity level, health-related quality of life and cognitive factors (self regulation, outcome expectation, self efficacy, perceived social support, perceived environment) will be evaluated in the study.
NCT06248918 — Health Behavior
Status: Enrolling by invitation
http://inclinicaltrials.com/health-behavior/NCT06248918/
Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.
NCT06246968 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06246968/
A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Cyclosporin A on Triple Negative Breast Cancer With Defective DNA Repair
This will be a single arm, non-randomized, pre-surgical clinical trial of women with newly diagnosed triple negative breast cancer with high g-H2Ax (gamma H2AX antibodies) comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.
NCT06246786 — Triple Negative Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/triple-negative-breast-cancer/NCT06246786/
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients: Nakhon Phanom Hospital - a Single Blinded Randomized Control Trial
The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are: - To compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients Participants will be randomly divided into 2 groups, 1. Mastectomy flap fixation 2. Conventional surgery with non flap fixation. Researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery. Researchers will compare with conventional surgery to see if seroma formation, and wound infection.
NCT06243796 — Breast-cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT06243796/
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study
CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.
NCT06243432 — Advanced Breast Carcinoma
Status: Recruiting
http://inclinicaltrials.com/advanced-breast-carcinoma/NCT06243432/
PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer
OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with fulvestrant or trastuzumab. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with standard dose fulvestrant (Part B) or standard dose trastuzumab (Part C). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.
NCT06239467 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06239467/
Prospective Biomarker Analysis in HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2- advanced/metastatic breast cancer patients
NCT06236269 — Breast Cancer Stage IV
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer-stage-iv/NCT06236269/