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NCT ID: NCT06449417 Not yet recruiting - Breast Cancer Clinical Trials

Aurora: A Human-centered Program for Breast Cancer Patients in Chile, Easing Neoadjuvant Chemotherapy's Effects

Aurora
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Breast cancer is the most prevalent cancer worldwide and the leading cause of cancer death among women in Chile. The Aurora intervention program is designed to improve the quality of life and mitigate the physical consequences of breast cancer in patients undergoing neoadjuvant chemotherapy. It aims to promote physical activity through a human-centered design product system, incorporating elements of personal motivation, peer learning, and community engagement in alignment with the COM-B model. In a 9-week randomized controlled trial, we will include 30 female patients under 70 years undergoing neoadjuvant therapy for breast cancer in the Metropolitan Region of Chile. Baseline and post-intervention measurements will assess biopsychosocial breast cancer effects through a questionnaire as well as adverse physical effects through functional capacity tests. Biological consequences will be evaluated through lipid profiling, inflammation biomarkers, and tumor progression. In addition, Aurora's patient perception of behavior change will be addressed by analyzing the patient's records in a journal. Moreover, the perceived value of Aurora's design attributes influencing behavior change will be studied through in-depth interviews. Preliminary results describe Aurora's design process and indicate that it is well-received by patients, especially as its logbook is a valuable tool for self-reflection and progress tracking. The study anticipates the confirmation that significantly higher physical activity, improved quality of life, and enhanced functional capacity will be attained in the intervention group. The Aurora intervention program represents a novel approach to support breast cancer patients undergoing chemotherapy, emphasizing physical activity, peer learning, and self-reflection. The integration of the behavior change COM-B model and a human-centered design provides a facilitating tool for tailored interventions for breast cancer patients' needs. Yet, the potential correlation between physical activity, fatty acid metabolism, and chemotherapy response necessitates further exploration. The Aurora intervention program shows promise as a supportive tool for breast cancer patients undergoing neoadjuvant chemotherapy. Further research is imperative to evaluate the intervention's impact on patient outcomes, refine the design based on user feedback, and explore potential relationships among physical activity, fatty acid metabolism, and chemotherapy response.

NCT ID: NCT06447532 Active, not recruiting - Breast Cancer Clinical Trials

Use of Machine Learning Techniques for Serial Assessment of Systemic Inflammatory Markers in Breast Cancer Patients

INFLAMMATE
Start date: April 1, 2024
Phase:
Study type: Observational

Breast cancer is the most common cancer in women globally, with 2.3 million new cases diagnosed in 2020. Hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer is the most prevalent subtype, comprising 69% of all breast cancers in the USA. Within the tumor immune microenvironment, a higher intensity of myeloid cell infiltration and low levels of lymphocyte infiltration have been associated with worse outcomes. Markers in peripheral blood have emerged as predictive biomarkers that can be easily obtained non-invasively and at low cost. Experiments have confirmed the relative components of these tests (such as the immune cells) directly or indirectly participated in tumour occurrence, development, and immune escape, underscoring the potential use of laboratory tests as tumour biomarkers

NCT ID: NCT06445738 Not yet recruiting - Breast Cancer Clinical Trials

Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International Validation Experience

PROSPECTIVE
Start date: January 1, 2025
Phase: N/A
Study type: Interventional

The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery. The main question it aims to answer is: * Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.

NCT ID: NCT06444269 Not yet recruiting - Breast Cancer Clinical Trials

Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

1. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

NCT ID: NCT06443359 Recruiting - Breast Cancer Clinical Trials

HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER

Start date: November 13, 2018
Phase: N/A
Study type: Interventional

This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. After enrollment, participants will be stratified into 2 Groups based on the extent of axillary surgery. Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment.

NCT ID: NCT06441890 Recruiting - Breast Cancer Clinical Trials

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

BRE-10
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care

NCT ID: NCT06441474 Not yet recruiting - Clinical trials for Breast Cancer Female

Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women

Start date: December 2024
Phase:
Study type: Observational

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal observational study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

NCT ID: NCT06441240 Recruiting - Breast Cancer Clinical Trials

Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy.

NEORISK
Start date: November 1, 2023
Phase:
Study type: Observational

INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer. The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes. Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment. In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT. Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT.

NCT ID: NCT06440018 Not yet recruiting - Breast Cancer Clinical Trials

INSPIRE: A Multi-Cancer Early Detection Study

INSPIRE
Start date: June 20, 2024
Phase:
Study type: Observational

This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis

NCT ID: NCT06439940 Recruiting - Breast Cancer Clinical Trials

Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs

Start date: July 14, 2021
Phase:
Study type: Observational

Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test aims to improve the accuracy of cancer detection, thereby reducing patient mortality and healthcare costs. To develop this test, the discovery and validation phases have been completed. In addition, Machine learning and AI were used to determine the algorithm for breast cancer detection. The overall objective of this protocol is to implement a pilot test to enroll 1,000 women without a previous cancer diagnosis who are attending their annual medical check-up. To achieve this, we will develop the following specific objectives: Enroll women over age 35 who attend the gynecological annual check-up. Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR. Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems (USA) on mammogram images. Compare the results obtained from the clinical check-up (BiRad from mammogram), IMAGO Systems and RT-qPCR (Oncoliq breast test). Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test. Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey. Subsequently, a small blood sample of 3-5 mL will be drawn via venipuncture.