Effectiveness of persoNalized Care After Treatment for Nonmetastasized Breast Cancer Based On Risk of Recurrence, Personal Needs and Risk on (Late) Health Effects: the NABOR Study
Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly 'one-size-fits-all', but can be personalized based on patients' risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up. The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: 'what is the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS)'. Also the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients' need for support, shared decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated. Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR). The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care. In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands.
NCT05975437 — Breast Cancer
Status: Enrolling by invitation
http://inclinicaltrials.com/breast-cancer/NCT05975437/
Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer Patients - B-REST-Study
The goal of this prospective clinical trial is to improve patient compliance and performance of deep inspiration breath hold (DIBH) to further reduce the cardiac dose from left breast radiation, and to improve cooperation and patient satisfaction through an active and formal pre-treatment respiratory training program combined with relaxation training (R&R) in breast cancer patients undergoing adjuvant radiotherapy for left sided breast cancer. The main questions the study aims to answer are: - Does the use of communication training and the use of relaxation techniques (R&R) reduce the Maximum dose to the heart (Dmax) and improve further heart dose parameters in deep inspiration during adjuvant radiotherapy for breast cancer? - Does R&R improve longitudinal anxiety and quality of life under patients undergoing DIBH adjuvant radiotherapy for left sided breast cancer? Participants will be randomly assigned to either an experimental arm, which will receive the R&R, versus a standard arm that will not receive the R&R. - training program in the experimental arm includes breath hold training, music, and nature sounds that patients can listen to on an MP3 player - both groups complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up Researchers will compare the R&R group (interventional arm) to current conventional DIBH instruction (standard group) to see if Dmax to the heart decreases and compliance and satisfaction under patients rises.
NCT05975190 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05975190/
A Phase II Clinical Study of Lactobacillus Vaginalis Capsules for the Prevention and Treatment of Symptoms of Vulvovaginal Atrophy in Young Breast Cancer Patients Receving Ovarian Function Suppression (OFS) During Chemotherapy
This study is a prospective, randomized controlled, phase II clinical study with a planned enrolment of 60 patients. The study focuses on the efficacy and safety of Lactobacillus vaginalis capsules for the prevention and/or treatment of vulvovaginal symptoms in young breast cancer patients receiving ovarian protection during chemotherapy, in order to improve compliance and quality of life in breast cancer patients.
NCT05974449 — Breast Cancer Female
Status: Recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT05974449/
A Phase III, Randomized, Open-label Study to Evaluate Capecitabine Plus Pembrolizumab vs Pembrolizumab Alone as Post-operative Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy
The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab and capecitabine compare to pembrolizumab alone, on the invasive disease-free survival, in participants who have triple negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy associated with pembrolizumab.
NCT05973864 — Triple Negative Breast Neoplasms
Status: Not yet recruiting
http://inclinicaltrials.com/triple-negative-breast-neoplasms/NCT05973864/
Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study
The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are: - Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association. - Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women. The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.
NCT05972785 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT05972785/
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.
NCT05972343 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05972343/
A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients
Lymphedema is a devastating complication of breast cancer surgery that decreases the quality of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists have collaborated to refine a surgical technique known as LVB that may be used either as a preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB). Lymphatic reconstruction with LVB may be an improvement to the current standard of care for node positive breast cancer patients undergoing ALND.
NCT05970107 — Node-positive Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/node-positive-breast-cancer/NCT05970107/
A Randomized Phase II Window of Opportunity Clinical Trial of IL-4 +/- PD-1 Inhibition in Early-stage ER+ HER2- Breast Cancer
This proposal is for a Window of Opportunity (WOO) clinical trial using a novel combination of two Health Canada approved agents, cemiplimab (Libtayo) and dupilumab (Dupixent), for off label use in early-stage estrogen receptor positive (ER+) breast cancer.
NCT05967884 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05967884/
Olaparib Plus Low-Dose Alpelisib for Breast Cancer: A ComboMATCH Treatment Trial
This phase II ComboMATCH treatment trial studies the effect of adding a drug called BYL719 (alpelisib) to the usual treatment of olaparib in patients with breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Alpelisib blocks certain proteins, which may help keep tumor cells from growing and may kill them. It is a type of kinase inhibitor. Giving alpelisib in combination with olaparib may be able to improve treatment results for patients with metastatic breast cancer.
NCT05967286 — Anatomic Stage III Breast Cancer AJCC v8
Status: Withdrawn
http://inclinicaltrials.com/anatomic-stage-iii-breast-cancer-ajcc-v8/NCT05967286/
RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Researchers think adding benralizumab to the standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.
NCT05966584 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05966584/