View clinical trials related to Carcinoma, Ductal.
Filter by:RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.
This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.
To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.
Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be performed on 110 patients and the CarolIReS camera will be used preoperatively to localize SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named CarolIReS and their activity will be measured with a gamma ray counter. At the end of surgery, the CarolIReS camera will be used again to check the quality of surgery which will be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective of this study is to evaluate the performances of the CarolIReS camera in assessing the axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the possible correlation between the activity, the size, and the metastatic involvement of the SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve the efficiency of the SLN procedure
PRINCIPAL INVESTIGATORS - Rakesh Patel, MD- Radiation Oncologist - Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN - Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients. SAMPLE SIZE AND SITES: - Approximately 400 patients may be enrolled. - Up to 100 qualified U.S. sites may participate in this registry. ENDPOINTS: 1. PRIMARY ENDPOINTS - Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. - Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. - Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways: - Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. 2. SECONDARY ENDPOINTS - Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years. This includes: - Ipsilateral recurrence within the initially treated volume. (Within the tumor bed) - Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure) - Axillary nodal recurrence - Survival - to be recorded at each follow-up visit - Overall Survival - Disease Free Survival - Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments: - Ability to deliver treatment - Axxent System / Balloon Applicator performance 3. TREATMENT DEVICE The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry. OVERSIGHT COMMITTEE Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.
The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).
Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests. The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
This is a study on how to activate the immune system with a vaccine. The vaccine is made up of two proteins found in breast cancer: telomerase and survivin. The vaccine is given in combination with other drugs that may also have an effect on the immune system and attack the cancer. The goals of the study are: 1. to test the safety of the combination of agents 2. to find out what effects the treatment has on advanced breast cancer