Role of Metastases Directed Radiotherapy in Addition to Standard of Care Systemic Treatment in the Management of Extracranial Oligometastatic Breast Cancer
This is a phase III randomized study evaluating the benefit from adding metastases directed therapy and locoregional treatment of the primary in breast cancer patients diagnosed with de novo oligometastatic disease patients will be randomized to receive the standard of care (SOC) treatment vs. systemic treatment + Stereotactic Ablative Radiation Therapy. Responders will be randomized to either undergo loco-regional management of the primary tumor or not
NCT06144346 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06144346/
Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.
NCT06143020 — Postoperative Pain
Status: Completed
http://inclinicaltrials.com/postoperative-pain/NCT06143020/
The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer. Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.
NCT06142344 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06142344/
RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.
NCT06139107 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06139107/
a Randomized Trial for OLIGo Metastases Breast cAncer With or Without Metastasis-dIrected Therapy
OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negativeBC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy does not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT.
NCT06135714 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06135714/
Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect. The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
NCT06135493 — Peripheral Neuropathy Due to Chemotherapy
Status: Recruiting
http://inclinicaltrials.com/peripheral-neuropathy-due-to-chemotherapy/NCT06135493/
Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).
NCT06133647 — Ductal Carcinoma in Situ
Status: Recruiting
http://inclinicaltrials.com/ductal-carcinoma-in-situ/NCT06133647/
Promoting Resilience in Women With Breast Cancer
The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.
NCT06133348 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06133348/
High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia. The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. The study is multicenter, randomized, double-blind, and placebo-controlled. Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.
NCT06132776 — Chemotherapy-induced Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT06132776/
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast. Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy. In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response. There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
NCT06131632 — Inflammatory Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/inflammatory-breast-cancer/NCT06131632/