Active clinical trials for "Breast Diseases"

Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).

This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.

Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .

The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.

This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive, HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and anastrozole, which represents a novel and all biologic approach to the treatment of HR+, HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential biomarkers of response to palbociclib including cyclin D1, cyclin E1 and cyclin E2 expression levels, CDK 2, 4, and 6 levels, phosphorylated retinoblastoma expression and p16 levels. The researchers intend to use RNA sequencing to assess for other predictors of response in an unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated retinoblastoma expression as well as evaluate for potential mechanisms of resistance.

Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.

A prospective, non-randomized, single-center cohort study to evaluate the value of audio-guided meditation during breast biopsy procedures. The main criterion of judgment is based on the evaluation of tolerance, which includes anxiety and pain felt. This is assessed with questionnaires (STAI-ETAT and EN) before and after the procedure. Secondary endpoints include tolerance of additional physical pain, reduction in the number of per-procedure complications, overall satisfaction of the practitioner with the biopsy procedure, and comparison of the tolerance of the procedure in patients who practice meditation at home before the procedure

This study is a randomized, open-label, phase II study, comparing the efficacy and safety of trastuzumab plus aromatase inhibitors, with or without pyrotinib, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. This study was initially designed as a single institution study, however, currently, the study was extended to the multicenter study including 22 institutions over the country. Using the established prospective cohort data, a comparative study of robotic mastectomy with conventional mastectomy and reconstruction, and cost-effectiveness and satisfaction of robotic endoscopic surgery, and cost-effectiveness and satisfaction of reconstructive surgery are to be analyzed.