86 Clinical Trials for Various Conditions
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.
This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.
RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.
RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis. PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ.
This phase I trial studies talimogene laherparepvec given together with ipilimumab and nivolumab before surgery in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer. Ipilimumab and Nivolumab are immune checkpoint inhibitors that enhance immune response towards cancer cells. Talimogene laherparepvec is a modifies human herpes virus 1 that is an oncolytic virus targeting cancer cells and makes tumor microenvironment more immunogenic to promote immune response against cancer. This study will assess the safety and efficacy of talimogene laherparepvec, ipilimumab, and nivolumab, and provide an insight for further improvement of immunotherapy in breast cancer.
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.
This 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.
The purpose of this study is to improve our understanding of potential changes in size, shape and activity in some brain areas that can occur in women receiving different types of Breast Cancer therapy, and how these changes are related to the development of mild cognitive impairment as the result of these treatments.
This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.
According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.
This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer. The PI3K inhibitor BYL719 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving the PI3K inhibitor BYL719 together with letrozole may kill more tumor cells
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.
This pilot clinical trial studies new ways to monitor the impact of hypofractionated image guided radiation therapy in treating patients with stage IV breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells
This pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue in the laboratory from patients receiving ZA may help doctors learn more about the effects of ZA on cells. It may also help doctors understand how well patients respond to treatment.
Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast. However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks. In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer. PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer. PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold markers in the area where the tumor was removed may help doctors better direct radiation therapy and help reduce the risk of cancer recurrence. PURPOSE: This phase I trial is studying how well radiation therapy using gold markers works in treating women with early-stage breast cancer.
The goal of this clinical research study is to learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer as well as in the breasts of young breast cancer patients (less than age 40 years). Researchers also hope to learn how often the results of the MRI changes the type of surgical treatment that is recommended and understand the costs associated with using MRI in the diagnostic process. Researchers also want to use a different way of looking at the MRI scans to learn if they can more easily learn the difference between a cyst and a tumor.