View clinical trials related to Ductal Carcinoma In Situ.
Filter by:Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size. After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life. This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.
The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.
This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS. Hypotheses: - For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates. - Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy. - Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer. PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.
The primary objective of this study is to compare the diagnostic accuracy of Digital Breast Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in determining the size of breast cancer preoperatively. Secondary objectives include: 1. Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions. 2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT. 3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).
The purpose of this study is to test the hypothesis that chloroquine will reduce the ability of ductal carcinoma in situ (DCIS) to survive and spread. Participants will receive either chloroquine standard dose (500mg/week) or chloroquine low dose (250mg/week) for 1 month prior to surgical removal of the tumor.
This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.
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.
Primary Objectives: - To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) - To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS