Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the...
CarcinomaDuctal1 moreHypotheses: The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization. Overall Objectives: To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients...
Estrogen Receptor-positive Breast CancerInvasive Ductal Breast Carcinoma8 moreThis pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma...
Anatomic Stage 0 Breast Cancer AJCC v8Bilateral Breast Carcinoma4 moreThis clinical trial assesses if the use of a three-dimensional imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room (intraoperative imaging) for patients with breast cancer and breast ductal carcinoma in situ. Breast conservation surgery or lumpectomy is a standard of care (routine) procedure that removes the tumor and a rim of surrounding normal tissue (margins) while leaving as much normal breast tissue as possible. A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the primary tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed. As part of standard of care, surgeons take two-dimensional x-ray images of the tissue that has been removed in the operating room to assess if there is any additional tissue that should be shaved (removed) to get a negative margin. After the surgery is over, the tissue is examined once again by a pathologist in a laboratory to determine if there are any small pieces of tumor left in the margin that were not visible during surgery. If residual tumor is detected in the margin, a reoperation may be required to remove additional tissue until the tumor has been completely removed from the margin. Diagnostic procedures, such as intraoperative volumetric specimen imaging may reduce the rate of reoperation of for patients who previously underwent lumpectomy.
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk...
Deleterious BRCA1 Gene MutationDeleterious BRCA2 Gene Mutation4 moreThis pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In...
Atypical Ductal Breast HyperplasiaBRCA1 Mutation Carrier3 moreThis randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer.
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v814 moreThis is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v87 moreThis phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
Breast Ductal Carcinoma In SituBreast Lobular Carcinoma In Situ11 moreThis randomized phase I trial studies the side effects and best dose of endoxifen hydrochloride in treating participants who are undergoing breast surgery. Endoxifen hydrochloride may treat or reduce the risk of breast cancer.
Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With...
Breast Ductal Carcinoma In SituCOVID-19 Infection2 moreThis study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.
Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer
Breast Ductal Carcinoma In SituThis phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.