Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients (PRILI): A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating
The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury. This study intends to conduct a randomized, double-blind, single-center clinical study of pirfenidone versus placebo in the prevention of acute radiation induced lung injury after breast cancer surgery
NCT05704166 — Acute Lung Injury
Status: Recruiting
http://inclinicaltrials.com/acute-lung-injury/NCT05704166/
Multi-Functional Magnetic Resonance Imaging Modalities for Assessment of Breast Cancer Response to Neoadjuvant Chemotherapy
The goal of this observational study is to investigate and validate multi-parametric magnetic resonance imaging (MRI) modalities for assessment of breast cancer response to neoadjuvant chemotherapy in a multi-site and multi-MRI scanner platform setting. This study is conducted at Oregon Health & Science University (OHSU), University of Washington (UW), and University of Iowa (UI) using Siemens, Philips, and General Electric MRI scanners, respectively. MRI is a type of scan that uses a very strong magnet and no radiation to take very detailed pictures of parts of the body. MRI is often used as standard of care to take pictures of breast tumor(s) before and after chemotherapy treatment in order to measure the tumor size changes in response to treatment, and in order to plan for surgery. MRI is used because the images it takes are very clear and the borders of the tumor can be measured very accurately. However the tumor size alone is often not a good early indicator of whether or not the tumor responds to treatment. Tumor size change usually happens late during the period of treatment, and tumor size measured with MRI after treatment can overestimate or underestimate the residual cancer. This makes it difficult to do the right surgical planning. In addition to measuring tumor size, the MRI scans in this research study will also measure changes in tumor blood vessels and the number of cancer cells per unit of tumor volume. The purpose of this study is to see whether MRI measurements of these functional tumor properties provide better early prediction and evaluation of breast cancer response to neoadjuvant chemotherapy than tumor size measurement. This is an observational study because the MRI procedures are not expected to have an effect on health outcomes. Eligible participants on this study are receiving standard of care neoadjuvant treatment for their cancer.
NCT05704062 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05704062/
Oncologic Safety of Sentinel Node Biopsy in Clinically Palpable Axillary Lymph Node in Breast Cancer Patients
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.
NCT05703295 — Sentinel Lymph Node Biopsy
Status: Not yet recruiting
http://inclinicaltrials.com/sentinel-lymph-node-biopsy/NCT05703295/
Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial
The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are: 1. Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives. 2. Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications. 3. Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain. 4. Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats. Participants can complete all parts of the study at home. They will: 1. Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months. 2. Attend 3 meetings in the first month of the study, all of which can be held via a video conference. 3. Use an electronic pill bottle to track their use of their AI medication. 4. Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program. Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.
NCT05703178 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05703178/
Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education
The goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.
NCT05700396 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05700396/
An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging
The goal of this pilot observational study is to learn about the feasibility of collecting patient-reported data and stool and blood samples from patients age 65 and older treated with aromatase inhibitor therapy for breast cancer. Participants will be treated with standard of care aromatase inhibitor therapy and will undergo serial phlebotomy, complete patient-reported questionnaires, and submit serial stool samples. The main exploratory translational questions it aims to obtain preliminary data for are: - What are the effects of aromatase inhibitor therapy on biomarkers of aging? - What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.
NCT05700006 — Aging
Status: Recruiting
http://inclinicaltrials.com/aging/NCT05700006/
Prognostic Value of Some Biochemical Markers in Breast Cancer
breast cancer is the most common type of cancer in women and first cause of cancer death among them. in Egypt it constitutes 33% of female cancer cases and more than22000 new cases diagnosed each year. there are many prognostic factors for breast cancer as Tumer size, axillary lymph node status, hormonal receptor status, and tumer markers as Ca15-3 and interferon gamma.
NCT05699577 — Breast Cancer Female
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT05699577/
Analysis of the Cost of Using FLUOrescence in Green of Indocyanine for the Detection of the Sentinel Lymph Node in the Breast Cancer.
The purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (Indocyanine Green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...
NCT05699291 — Sentinel Lymph Node
Status: Completed
http://inclinicaltrials.com/sentinel-lymph-node/NCT05699291/
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase III Efficacy and Safety Study of Thero2-01S22 add-on Therapy on Top of First-line Anti-HER2 Targeted Treatment of Patients With Metastatic Breast Cancer
Trastuzumab and pertuzumab based regimen are the standard of care for patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC), significantly improving survival outcomes. However, an unmet medical need remain for patients with disease refractoriness and recurrence. Interestingly, HER2 over-expression is associated with upregulation of vascular endothelial growth factor (VEGF) in cancer cells in vitro and in vivo. Preclinical studies indicated that VEGF expression is positively regulated by HER2 signaling. In the clinical setting, HER2 over-expression correlated significantly with VEGF over- expression in samples from patients with breast cancer. There is, therefore, a biologic rationale for targeting both HER2 and VEGF pathways in patients with HER2-positive breast cancer. PURPOSE: The hypothesis that justifies this research is that the addition of Thero2-01S22 as add-on therapy on top of first line anti-HER2 targeted treatment will improve the efficacy of anti-HER2 targeted containing regimen at the metastatic setting for breast cancer.
NCT05698186 — HER2-positive Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/her2-positive-breast-cancer/NCT05698186/
Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.
This project will investigate the efficacy of a cognitive remediation programme in patients treated for breast cancer. patients will be randomized between "no intervention" and "intervention programme". Efficay will be assessed in term of improved quality of life.
NCT05690828 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05690828/