A Randomized Pilot Test of the Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Functional Recovery
The goal of this research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. Physical therapy before cancer treatment aims to help with early identification and self-management of physical and functional side effects from cancer treatment. Side effects could be joint pain, muscle weakness, or fatigue that contribute to functional impairment. The main questions this study aims to answer are: 1. Determine the feasibility (acceptability and suitability) and potential effects of an early intervention called 'Moving On-After Breast Cancer' (MOve-ABC) on physical and functional side effects of cancer compared to enhanced usual care in a large academic medical system to help us refine and adjust the intervention in preparation for a large randomized, double-blinded, controlled trial. 2. Determine whether MOve-ABC also affects patient self-management and provider knowledge and behaviors related to detection and management of physical and functional effects associated with cancer. Participants will be randomly assigned to either of the two arms of the study which are 'Intervention' and 'Enhanced usual care.' Participants in the intervention arm will receive: 1. Planned care per their oncology physician team plus: 1.1. Patient education on physical function in breast cancer 1.2. Physical therapy evaluation 1.3. Individualized home exercise prescription 1.4. Education materials in the form of a study booklet, study website, text messaging, and phone calls 1.5. Monthly monitoring of physical and functional survey scores to identify the need for physical therapy and provide referrals as needed Participants in the enhanced usual care arm will receive: 1. Planned care per their oncology physician team plus 1.2. Monthly monitoring of their physical functional scores to identify the need for physical therapy and provide referrals as needed All participants will attend three in-person visits for clinical measurements.
NCT06081127 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06081127/
Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study
The goal of this clinical trial is to compare the therapeutic effects of chemotherapy followed by surgery and surgery followed by chemotherapy in patients with locally advanced breast cancer（LABC). Patients with LABC will be randomly divided into two groups, each receiving chemotherapy followed by surgery or surgery followed by chemotherapy. The main comparison was between the disease-free survival (DFS) of two groups of patients, with the secondary study endpoint being overall survival (OS); Five year survival; Local recurrence or distant metastasis rate.
NCT06080620 — Locally Advanced Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/locally-advanced-breast-cancer/NCT06080620/
Rehabilitation Needs in Patients With Early Breast Cancer: Validation of a Questionnaire Patient Reported Outcome
Breast cancer survivors typically experience fatigue, pain, insomnia, depression, anxiety, difficulty in concentrating, memory impairment, body image problems, vaginal dryness, interest in sex decreasing, hot flashes, gain weight, and infertility. All of these problems affect quality of life (QoL) mainly during the early survival and they become even more important to understand and address if long-term effects could be prevented. The use of PROs in care settings has demonstrated improvement in provider/patient communication, recognition of previously unrecognized issues, as well as patient satisfaction with care. In order to allow to patients the use of the PRO "survivorship concerns" in their mother tongue, it is imprtant to have validated translations with transcultural adaptation. The main goals of this multicentric study are the translation, adaptability and transcultural validation of the PRO questionnaire "survivorship concerns" to put in evidence rehabilitation needs in breast cancer patients in early stage.
NCT06080607 — Quality of Life
Status: Recruiting
http://inclinicaltrials.com/quality-of-life/NCT06080607/
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy. The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to: - Experimental group: JSKN003 monotherapy - Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy
NCT06079983 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06079983/
A Prospective Study of the Healthy Eating and Active Lifestyle (HEAL): Breast Cancer Program on Survivorship Outcomes
The goal of this single-group prospective study is to examine the impact of the Healthy Eating and Active Lifestyle (HEAL) Breast Cancer program on participants' perceived stress, biometrics, basic labs, lifestyle behaviors, self-efficacy, mental health, and quality of life. Participants will participate in an 8-week program of 90-minute virtual sessions each week to decrease risk of cancer recurrence. Program participants can choose to participate in the research study which will include data collection (surveys, biometrics, basic labs). The data collection will occur at four timepoints - baseline prior to program start, post-program, 3 month follow-up, and 6 month follow-up.
NCT06078761 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06078761/
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.
NCT06076772 — Metastatic Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/metastatic-breast-cancer/NCT06076772/
Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
NCT06076616 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT06076616/
A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer
A Phase 1, open-label, dose-escalation clinical trial of MBQ-167 in participants with advanced Breast Cancer for whom Standard of Care (SOC) has failed or has proven intolerable.
NCT06075810 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06075810/
Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study
The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are: - Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants. - Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk. Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges. Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk. Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).
NCT06073717 — Cognitive Impairment
Status: Recruiting
http://inclinicaltrials.com/cognitive-impairment/NCT06073717/
Watch Your HeaRT Study - Screening and Risk Analysis of Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer
The goal of this interventional study is to evaluate the risk of atrial fibrillation (AF) and other cardiac arrhythmias and diseases in breast cancer patients treated with radiation therapy (RT). In addition to regular follow-up of patients by the radiation oncologist for 5 years, cardiovascular screening at the end of follow-up, combining the use of a connected watch and a cardiological check-up, could make it possible to identify precisely the types and frequencies of these sometimes asymptomatic, and probably underestimated, cardiac diseases. The main questions it aims to answer are: - To assess the incidence of AF and other cardiac arrhythmias and diseases occurring within 5 years after RT - To evaluate absorbed doses in the heart and cardiac substructures (chambers, conduction nodes, coronaries, pulmonary veins) based on auto-segmentation models developped with deep learning algorithms - To investigate whether the risk of AF and other cardiac arrhythmias and diseases is associated with cardiac irradiation characterized by these absorbed doses (dose-response relationship) Participants will be included between 2023 and 2025, 5 years after their RT: - Retrospective data collection will be based on a medical questionnaire designed to identify cardiac pathologies present prior to RT and those having occured in the past, between RT and 5 years post-RT. - Cross-sectional data collection will be based on screening for cardiac pathologies using a connected watch worn for 1 month (silent AF screening) and a cardiology consultation (including ECG and echocardiography) to identify cardiac pathologies at 5 years post-RT possibly not identified in the retrospective data collection.
NCT06073509 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06073509/