View clinical trials related to Early-Stage Breast Cancer.
Filter by:RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population. PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.
While the role of automated breast ultrasound (ABUS) as an alternative to hand-held ultrasound (HHUS) in breast cancer screening has been established, the use of ABUS in preoperative evaluation of newly diagnosed breast cancer patients is still limited. This may be because axillary areas are not included in the scanning area of ABUS. Newly diagnosed breast cancer patients have undergone axillary US to predict axillary lymph node metastasis before surgery, in combination with preoperative breast US, in many institutions. However, recent studies have reported that sentinel lymph node biopsy alone is sufficient for diagnosis and treatment of axillae of patients with early-stage breast cancer, because the incidence of axillary lymph node metastasis is very low. Therefore, the clinical significance of preoperative axillary US is being lowered in patients with early-stage breast cancers. Thus, considering that coronal images provided by ABUS may be more advantageous for detection of multifocal or multicentric cancer, we hypothesized that ABUS could replace HHUS in preoperative staging of patients with early-stage breast cancers (clinical Tis, T1-2/N0 cancers) for whom preoperative axillary US is not necessary. The purpose of this study was to prospectively compare the diagnostic performances of ABUS and HHUS in preoperative evaluation of patients with early-stage breast cancers. This study will be conducted with institutional review board approval, and written informed consent will be obtained. From the Jan 2019 to Dec 2021, 675 patients diagnosed with early-stage breast cancer will be enrolled from the three institutions. Both ABUS and HHUS will be performed on each patient before surgery. Breast radiologists independently review ABUS and HHUS images. They detect all visible lesions and record the location and size of them. They characterize all detected lesions by using BI-RADS category. The primary object is to compare the diagnostic performance of ABUS and HHUS as preoperative staging tool in women with known breast cancers. The sensitivities and specificity of each US mode for the detection of breast cancers are calculated on a per-lesion basis. McNemar's test and Fisher's exact test are used to compare the sensitivities and PPVs for ABUS and HHUS. Significance testing on the lesion level and patient level is conducted using generalized estimating equations (GEEs) with a logit link and an independent working correlation structure to adjust the effect of clustering on radiologists and patients. GEEs are utilized to compare the sensitivities and PPVs for ABUS and HHUS. Diagnostic performance are assessed with receiver operating characteristics curve analysis. Area under the curves are calculated from both parametric and trapezoidal curve fitting. Agreements between tumor size measured by each US mode and pathologic the tumor size are analyzed with the intraclass correlation coefficient (ICC) and 95% Bland-Altman limits of agreement.
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.
This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes. The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.
The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.
This bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.
REaCT-RETT will demonstrate the non-inferiority of concurrent compared to sequential endocrine therapy in patients receiving post-operative radiotherapy for early stage breast cancer.