View clinical trials related to Breast Cancer.
Filter by:This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or non-small cell lung cancer.
The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to reconstruct a breast mound with preservation a patient's natural skin envelope. Preservation of the nipple and areola complex during mastectomy and breast reconstruction is associated with improved quality of life and a better cosmetic result. However, this surgical technique relies on tenuous blood supply to maintain the nipple and areola. Therefore a certain proportion of women will actually lose their preserved nipple-areolar complex due to vascular insufficiency. Furthermore, some women may find out after a nipple-sparing mastectomy that cancer had invaded the nipple-areolar complex, and would require another operation to completely remove the cancer. Despite these devastating complications, there have been no controlled studies to investigate mechanisms to reduce the chance of their occurrence. Our research study will use a pre-operative minor procedure to enhance blood flow to the nipple-areola complex prior to standard nipple sparing mastectomy among eligible women undergoing mastectomy for breast cancer or risk reduction. A secondary objective is to test how many women actually have active cancer in their nipple at the time of this minor surgical procedure, prior to standard NSM. The investigators hypothesize that our innovative and novel nipple-delay procedure will reduce the risk of loss of the nipple due to vascular insufficiency and may be of benefit to identify the small proportion of women with nipple-areola complex involvement, in order to optimize the ultimate cancer ablation. For this study the investigators propose to undertake a Pilot RCT as the first step in the evaluation of a delay procedure prior to NSM, and the results will be used to determine the feasibility and inform the optimal design for a definitive RCT. This study question has the potential to set a new standard of care in the management of women seeking NSM for the management of their breast cancer.
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.
A malignant tumor has higher temperature than normal tissue and the temperature of the tumor is dependent on the tumor growth rate. Thus tumor temperature is the universal indicator of tumor activity. The temperature changes begin in the stage of atypical hyperplasia and increased proliferation and this opens up the possibilities for detection of patients with high risk lesions. Microwave radiometer (RTM-01-RES) allows measurement of temperature changes of internal tissue at the depth of several centimetre and allows visualization of the temperature on the thermogram and temperature field. It is noninvasive and the measurement of internal temperature is based on receiving natural electromagnetic radiation from the tissue in the gigahertz (GHz) frequency range. The device is absolutely harmless and has no risk because it does not emit any radiation. It can be used repeatedly as a method of monitoring. Microwave radiometry has successfully completed seven clinical trials of more than 1000 patients in different countries. Microwave device (RTM-01-RES) is used in more than 300 medical centers in 30 countries. Medical technology of microwave radiometry is included in the nomenclature of medical services in the Russian Federation, the Ministry of Health and is part of the standard of care for patients with malignant tumors of the breast. This method of microwave radiometry is recommended by leading Russian mammalogists in the National guidelines of breast care. The investigators would like to use the device in clinics in Scotland and later United Kingdom (UK) for breast diagnosis and monitoring treatment. During 3 months the investigators aim to examine 150 patients with breast cancer and 150 patients without cancer who will be the control group. The results of temperature measurement will be compared with the results of histology, in particular, tumour cellulants p53 expression and other gene expression data for metabolic biomarkers and other tumor indicator. Statistical analysis of data will be performed. The device and initial training will be provided by RES Company (device producer).
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment. The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts. Real Imaging is continuously developing the technology including image acquisition hardware and objective analysis of the imaging biomarkers. To further improve and optimize this novel metabolic imaging technology, Real Imaging will introduce an improved imaging device. The purpose of this clinical study is to collect more imaging data in order to establish superiority of the newer device over the previous one. The investigators hypothesize is that the new device will be at least as good as the previous one.
Patients will be treated in a dose escalation scheme to investigate a role for the addition of a statin in the treatment of estrogen receptor positive breast cancer. Patients will take oral rosuvastatin daily. The maximum number of patients evaluable for a DLT is 12. Dosing will be as follows: Cohort 1 - rosuvastatin 20mg, Cohort 2 - rosuvastatin 40mg. The patients will have a total of 4 blood draws and 4 breast biopsies. The breast biopsies will be collected to evaluate cholesterol metabolites and tumor microenvironment characteristics including gene expression profiling and metabolomics. Sampling will occur at study entry, week 4, week 8, and at the time of surgery in early stage patients or at week 16 for metastatic patients. Patients will begin endocrine therapy following the acquisition of week 4 samples (blood and tissue biopsy).
The goal of this behavioral research study is to compare 2 different types of residential group programs to help researchers learn if and how well these groups may help to improve physical and emotional well-being in patients with stage IV breast cancer.
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.
This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy.
The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab. This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.