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Surgery

Early Surgery for Newly Diagnosed Stage IV Breast Cancer

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer (NCT01242800)

Summary

Approximately 3 to 4 percent of patients with newly diagnosed breast cancer have stage IV (metastatic) disease. When this occurs, the tumor is not usually removed unless it is causing symptoms such as ulceration or pain. (This is called palliative surgery.) It is not known whether removing the breast tumor before it causes problems (called early surgery) may help to extend survival. The goal of this trial is to compare early surgery with standard palliative surgery in individuals with metastatic disease who have a tumor in the breast. To be eligible, participants must have an intact primary (not recurrent) tumor in their breast.
This is a Phase III trial

Aggressive Local Therapy for Bone Metastases

Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients (NCT00929214)

Summary

Women with metastatic breast cancer that has spread to the bones are currently treated with chemotherapy or hormone therapy. Both chemotherapy and hormone therapy are systemic treatments that travel through the bloodstream to go after cancer cells that may be anywhere in the body. It is possible that using local therapy -- surgery and/or radiation -- along with systemic therapy may help control breast cancer cells that have spread to the bone. The goal of this study is to find out if adding local therapy (surgery and/or radiation) to standard systemic therapy (chemotherapy or hormone therapy) in the treatment of women with breast cancer that has metastasized to the bone can help to control the disease for a longer period of time than standard therapy alone. Participants must have no more than three areas of bone metastases.
This is a Phase II trial

Nipple-Sparing Mastectomy

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy (NCT01002014)

Summary

Many women choose to have a skin-sparing mastectomy when they have immediate breast reconstruction. During a traditional skin-sparing mastectomy, all of the breast skin is preserved, except for the nipple and areola. Nipple-sparing mastectomy is a procedure that allows women to keep their nipple and areola as well. The goal of this study is to observe the cosmetic outcomes, patient satisfaction, and complications of nipple-sparing mastectomy. To be eligible, women must be planning to have either a therapeutic or prophylactic mastectomy.

Breast-Conserving Surgery to Treat Multiple Breast Tumors

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer (NCT01556243)

Summary

Early data suggest that one reason the mastectomy rate is increasing is due to the increased identification of multiple ipsilateral breast cancers (MIBC)—more than one tumor in the same breast. This may be because of the perceived belief that women with MIBC are at greater risk of having a local recurrence. The purpose of this study is to assess the local recurrence (LR) rate that occurs after breast conserving surgery (lumpectomy) is performed in patients with MIBC. To be eligible, participants must have two or three foci of biopsy-proven breast cancer in no more than two quadrants of the breast.
This is a Phase II trial

A New Way to Assess Tumor Margins During Surgery

A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery (NCT01796041)

Summary

Studies suggest that up to 70 percent of women who choose to have a lumpectomy need a second operation (a re-excision) because the initial surgery did not result in a clean margin--an area around the tumor that is cancer-free. Currently surgeons feel the breast tissue to determine whether they have obtained a clean margin. This trial is looking at whether an imaging technique that can be performed during surgery makes it easier to identify tumor margins and decreases the need for a second operation. To be eligible, participants must be planning on having a lumpectomy.
This is a Phase O trial

Cryoablation (Freezing) Instead of Surgery & Radiation for Older Women with Small Tumors

Freezing Alone Instead of Resection and Radiotherapy Of Small Breast Tumors: A Study of Cryoablation in the Management of Prognostically Favorable Early Stage Breast Cancer in Elderly Women (NCT01992250)

Summary

Cryoablation uses extreme cold to destroy cancerous tumors. The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures (-276°F) to freeze and kill the breast tumor. The procedure does not leave any significant scarring. The researchers believe that cryoablation can successfully destroy a small tumor (no greater than 2.0 cm). This study is looking at how well cryoablation works to prevent local recurrence in women 70 and older who would have otherwise had surgery and radiation to treat an early-stage invasive breast cancer. To be eligible for this study, a woman must have a tumor that is classified as Luminal A on a core needle biopsy.

Reducing Post-Operative Pain From Breast Reconstruction

A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT02044302)

Summary

Opioids and sedatives like diazepam (valium) are the drugs typically used to manage pain in women who are having a mastectomy with breast reconstruction. Opioids are effective, but they can cause side effects like nausea, vomiting, sedation, and constipation. Bupivacaine is a local anesthetic. Botulinum toxin (commonly known as Botox) is a muscle relaxant. Both block the nerve impulses that send pain signals to the brain. This study is investigating whether using bupivacaine and Botox, either alone or together, during surgery will provide better pain control post-surgery and reduce incidences of opioid side effects in women who are having a mastectomy with breast reconstruction.
This is a Phase II trial

Regional Anesthesia and Breast Cancer Recurrence

Regional Anesthesia and Breast Cancer Recurrence (NCT00418457)

Summary

Surgery is the primary and most effective breast cancer treatment. The goal of surgery is to remove all of the cancer. However, scattered micrometastases and/or a few tumor cells are almost always missed. While a variety of factors determine whether a woman will go on to have a breast cancer recurrence, recent animal and human studies suggest that replacing general anesthesia/analgesia with regional anesthesia/analgesia results in a lower incidence of breast cancer metastases. This trial will help determine whether the risk of recurrence differs between women who receive regional anesthesia/analgesia compared to those who receive general anesthesia/analgesia.
This is a Phase III trial

Reducing Mastectomy-Related Pain

Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer (NCT00859157)

Summary

Post-operative mastectomy pain is a routine occurrence in women being treated for breast cancer. Tumescent mastectomy is a new surgical technique that involves use of a local anesthesia instead of a general anesthesia. The local anesthesia causes the breast to swell during surgery, which may reduce post-operative pain. The goal of this trial is to compare pain experienced by patients who receive a tumescent mastectomy with that of patients who receive a standard mastectomy. To be eligible, patients must be planning on having a mastectomy without immediate breast reconstruction.

Lumpectomy and Radiofrequency Ablation

ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer (NCT01153035)

Summary

During a lumpectomy, the surgeon removes the tumor as well as some tissue surrounding the tumor. After the surgery, if the pathologist finds that there were cancer cells near the edges (margin) of the removed tissue, a second operation may be needed to remove more tissue. Radiofrequency ablation is a procedure that uses heat generated by an electrical current to destroy tumor tissue. Researchers believe that radiofrequency ablation given during a lumpectomy may help to ensure that no cancer remains in the margins. This may reduce the need for a second surgery. It also may reduce the chance of a local recurrence. The purpose of this trial is to see if lumpectomy followed by radiofrequency ablation reduces the need for a second surgery. To be eligible, participants must be planning to receive a lumpectomy.

"Rational Dose" Gamma Knife Radiosurgery for Brain Metastases

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection (NCT02005614)

Summary

The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of Gamma Knife® Radiosurgery is a non-surgical procedure that is recognized as the preferred treatment for brain tumors. "Rational dose" is a method that assesses the best dose of radiation by taking into account tumor volume, prior radiation, and the relative resistance of the tumor to radiation. (Some tumors, like melanomas, are considered radioresistant wheres others, like breast cancer, are considered radiosensitive.) This study is evaluating the effectiveness of and side effects associated with using the rational dose method for gamma knife radiosurgery to treat brain metastases. The information will be used to design future studies on gamma knife radiosurgery. This study is enrolling patients with brain metastases from breast cancer as well as other types of cancers.
This is a Phase II trial

Radiation During Lumpectomy Surgery for Stage I-III Breast Cancer

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer (NCT01960803)

Summary

Researchers are studying new ways to give radiation therapy during or after breast cancer surgery. Intraoperative Electron Radiation Treatment (IOERT) is a radiation treatment that delivers a concentrated beam of radiation directly to the tumor bed. This study is investigating the feasibility and tolerability of giving a single dose of IOERT at the time of breast conserving surgery to patients with early stage breast cancer. To be eligible, patients must be scheduled to have a lumpectomy for stage I, II or III breast cancer.

Lymph Node Dissection & Radiation after Neoadjuvant Therapy to Treat Positive Node(s)

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (NCT01901094)

Summary

Researchers are studying the best way to treat women who have received neoadjuvant therapy (treatment given before surgery) and are found to have a positive sentinel node(s) during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery. Axillary lymph node dissection (ALND) removes tumor cells that have spread to nearby lymph nodes or other nodes in the axillary (armpit) area. This study is comparing the effectiveness of ALND plus radiation therapy to radiation therapy alone in treating women who had neoadjuvant treatment and were found to have a positive sentinel node(s) during surgery.
This is a Phase III trial