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Browse 4,817 clinical trials for breast cancer. Find studies that match your criteria and connect with research centers.
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NCT06708910
Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients. The main question it aims to answer are: Primary endpoint: 1\) Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment) Secondary endpoint(s): 1. Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment) 2. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment) 3. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment) 4. Evaluation of pre-treatment (baseline) 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction) 5. Evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction) 6. Evaluation of 18F-FDG PET/MRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction) The guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET/MRI, including dedicated 18F-FDG PET/MRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard. The study protocol involves the following examinations for all included patients: 1. Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast 2. Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after the first two cycles of systemic therapy 3. Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery
NCT04343950
The aim of this project is to assess the impact on health and economics of the implementation of text messaging (SMS) in cancer screening programs. Three interventions with SMS will be evaluated through community trials. In the colorectal cancer screening program the following interventions will be tested: a) Participation reminder: six weeks after sending the invitation letter of the colorectal cancer program if there has not been a response, a reminder SMS will be sent in front of the usual method by letter; b) Reminder to return the fecal occult blood test: SMS reminder of test delivery versus no intervention. This reminder will be sent to the individuals who have gone to the pharmacy to pick up a fecal occult blood test and they have not returned it after 14 days. The impact on participation will be analyzed and, if applicable, the proportion of advanced neoplasms will be calculated by increase in participation. In the breast cancer screening program, the invitation by SMS versus the usual invitation by letter will be studied in women who had participated in the previous screening round. The impact on participation will be analyzed. A cost-effectiveness analysis of the three interventions will be carried out. The incremental cost ratio of the interventions between cost variation and effectiveness variation will be calculated.
NCT07183813
The aim of this study is to evaluate the effects and safety of acupuncture on anxiety and/or depression among patients with breast cancer.
NCT07180810
A randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group.
NCT04994067
This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.
NCT06125314
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous reports showed variations in the criteria used to define the HER2-low subtype. Besides, data on the clinical features and prognosis of HER2-low patients are limited, and it is still unclear whether HER2-low BC has a prognostic value. Identifying the prevalence and clinical features of HER2-low BC can help establish a more accurate and reproducible definition of HER2-low BC. In the Gulf Cooperation Council (GCC) region, BC is the most common malignancy in women and still poses a significant burden on healthcare resource utilization, moreover, there is only one record for reimbursed HER2 IHC status, categorized as HER2-positive and HER2-negative. It is important to understand the prevalence, clinical features, and outcomes of HER2-low in BC patients from the GCC In this retrospective, non-interventional, multicenter study, the aim to describe the prevalence of HER2-low BC among the current HER2-negative BC population using rescored HER2 IHC samples. The local treatment patterns and the outcomes will be analyzed using the information abstracted from the corresponding medical chart review. The study will cover the GCC region countries (United Arab Emirates \[UAE\], Saudi Arabia, Qatar, Kuwait, and Oman)
NCT02893761
A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.
NCT05381038
This pilot feasibility study aims to set the foundation to investigate the applicability of QPOP drug selection followed by CURATE.AI-guided dose optimisation of the selected azacitidine combination therapy for solid tumours using CURATE.AI within the current clinical setting. QPOP will identify drug interactions towards optimal efficacy and cytotoxicity from the pre-specified drug pool based on ex vivo experimental data from the individual participant's tissue sample model. With these drug interactions, QPOP will identify the optimal drugs for the specific participant whose biopsy provided the cells for the ex vivo experimentation. Subsequently, CURATE.AI will be used to guide dosing for the selected combination therapy for that participant. Individualised CURATE.AI profiles will be generated based on each participant's response to a set of drug doses. Subsequently, the personalised CURATE.AI profile will be used to recommend the efficacy-driven dose. CURATE.AI will operate only within the safety range for each drug pre-specified for each participant. This pilot feasibility study will inform the investigators on the logistical and scientific feasibility of performing a large-scale randomised controlled trial (RCT) with the selected azacitidine combination therapy regimens and response markers. A secondary objective is to collect toxicity and efficacy data using established and exploratory response markers within and in-between cycles as exploratory outcomes.
NCT07188116
This study was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients.
NCT05425550
Multicenter, prospective, randomised and controlled study to evaluate the medidux™ app during an observation period of 12 weeks (maximum 16 weeks in case of shifts in the initially planned therapy).
NCT05414357
Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.
NCT07184749
Despite growing awareness of neurocognitive and psychological complications of systemic chemotherapy administration in breast cancer, prospective observational studies evaluating such effects in Egyptian breast cancer patients-especially with pre- and post-treatment assessments-remain limited. Given the rising incidence of breast cancer in Egypt and the growing population of long-term survivors, it is essential to investigate the extent and nature of cognitive and psychological changes associated with treatment. The current study aims to fill this gap by prospectively evaluating neurological, cognitive, and psychological parameters in newly diagnosed breast cancer patients, using validated tools before and one year after treatment.
NCT06680921
This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.
NCT04069884
The purpose of this study is to validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.
NCT05216432
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).
NCT05585476
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
NCT06534918
The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.
NCT05382286
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
NCT07095114
The goal of this clinical trial is to learn if tattoos applied with Magic Ink is as safe as commercially available standard tattoo ink for the purpose of radiation in women with breast cancer undergoing radiation treatment. The main questions are: * Is the Magic Ink as safe as standard tattoo ink * Does Magic Ink continue to function and remain visible for radiation therapists during the treatment Participants will be consented and given a skin assessment. Once enrolled participants will be administered the Magic Ink tattoo instead of the standard tattoo ink in preparation for their radiation treatment. Participants will also complete a survey regarding body image. Skin assessment will occur again after the first week of radiation and at 3 months later. Throughout the radiation therapy the medical physicist will complete surveys about ease of set-up of the equipment.
NCT05116449
The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.
