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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

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.

Feasibility of Using Imaging to Look for Cancer Cells During Lumpectomy

Feasibility of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer(NCT02438358)

Summary

To take part in this study, you must have recently been diagnosed with stage I-III breast cancer and be planning on having a lumpectomy (breast conserving surgery). This study is investigating whether using the LUM imaging system during surgery makes it more likely the surgeon will remove the entire tumor and less likely that you will have positive margins (some tumor left behind) and need to have a second surgery.

Cryoablation (Freezing) Instead of Surgery & Radiation for Women Age 50+ 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 (FROST Trial) (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 50 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.

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

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.

A Study Comparing Active Surveillance to Treatment for Low-Risk DCIS

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial (NCT02926911)

Summary

To take part in this study, you must have recently been diagnosed with hormone receptor-positive (ER+/PR+) DCIS and not yet started treatment. Not all DCIS will go on to become invasive breast cancer. This means that some women being treated for DCIS are getting more treatment than is necessary. This study will compare active surveillance--a mammogram every six months and optional anti-estrogen therapy--to the standard of care for treating DCIS. The standard of care is surgery, which may be followed by radiation and/or anti-estrogen treatment. For more information. email: thomas.lynch2@duke.edu

MRI Before Breast Conserving Surgery for Newly Diagnosed Early-Stage Breast Cancer

Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART) (NCT00948285)

Summary

Breast conserving surgery removes the the tumor along with a rim of normal tissue (a surgical margin). Magnetic resonance imaging (MRI) is not currently used before surgery to help define the surgical area. This study will evaluate whether using MRI along with mammography and ultrasound is more effective than using mammography and ultrasound alone before surgery to obtain clean margins, reduce the need for a second surgery, and achieve a good cosmetic result. To be eligible, a woman must be a candidate for breast conserving surgery (lumpectomy).

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

Telapristone Before Mastectomy for High-Risk, DCIS or Stage I-II Breast Cancer

Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy (NCT02314156)

Summary

Telapristone is an anti-progesterone drug. Laboratory studies have found telapristone can prevent tumors from growing. Telapristone can be given as a pill or absorbed into the skin through a patch. Researchers want to see if giving telapristone before surgery can help prevent breast cancer in premenopausal women. This study is comparing the effectiveness of a telapristone pill or patch to a placebo pill or patch for preventing breast cancer in high-risk women and reducing risk of recurrence in women with DCIS or stage I-II breast cancer. To be eligible, a woman must be premenopausal and scheduled to have a unilateral or bilateral mastectomy.
This is a Phase II trial

Studying Tumor-to-Breast Ratio in Patients with DCIS or Early-Stage Breast Cancer

A Prospective Trial to AssessTumor:Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction (NCT02216136)

Summary

The size of the tumor compared to the size of the breast is referred to as the tumor-to-breast volume ratio. The ratio is a factor in whether a woman has the option of having a lumpectomy. In this study, women who are scheduled to undergo lumpectomy, mastectomy, or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or early stage breast cancer will have a breast MRI that determines their tumor-to-breast volume ratio prior to surgery. After surgery, patients will complete questionnaires designed to assess their quality of life.

A Tool to Help Women Decide Whether to Have a Contralateral Preventative Mastectomy

Decision Making Tool for Contralateral Prophylactic Mastectomy (NCT02918474)

Summary

To take part in this study, you must be seeing a surgeon at MD Anderson Cancer Center and have recently been diagnosed with DCIS or stage I-III breast cancer. This study is evaluating whether an online decision support tool designed for women with DCIS or stage I-III breast cancer helps you and your doctor discuss the option of having a contralateral prophylactic mastectomy (removal of breast that does not have cancer). If you take part in this study, you will be answering a questionnaire about the decision support tool.

Using Regional & General Anesthesia to Reduce Pain & Nausea After Surgery & Reconstruction

Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting(NCT02913573)

Summary

To take part in this study, you must be scheduled to have a mastectomy followed by immediate breast reconstruction with a tissue expander or implant. General anesthesia is used before breast cancer surgery. A pectoral nerve block is an anesthetic used to numb the chest area. In this study, researchers will see whether women who receive a pectoral nerve block along with general anesthesia immediately before surgery have less pain, nausea and vomiting after surgery and reconstruction than women who receive general anesthesia alone.
This is a Phase II trial