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Inflammatory Breast Cancer
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Inflammatory Breast Cancer
Biomarker status:
 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
 Triple negative (ER-/PR-/HER2-)

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Surgery: Reconstruction

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.

A New Patient-Controlled Tissue Expander for Reconstruction

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction (NCT01425268)

Summary

As part of an implant reconstruction procedure, temporary tissue expanders are placed under the skin and muscle following the mastectomy. These expanders are used to stretch out the tissue and make room for the permanent breast implant. The expander is typically inflated over time, a process that requires the patient to go to the clinic to have a saline solution injected into the expander. The AirXpanders Tissue Expander System is a new patient-controlled breast tissue expander. It has a small handheld wireless controller that administers small amounts of CO2 into the device to stretch the skin. The goal of this trial is to compare the AirXpander Tissue Expander System to the traditional saline tissue expander. To be eligible, women must be planning to have breast reconstruction that requires tissue expansion.
This is a Phase II trial

Improving Outcomes in Immediate Reconstruction With Implants

The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants (NCT01315119)

Summary

Many women who have a mastectomy to treat or prevent breast cancer prefer to have immediate reconstruction with implants rather than delayed reconstruction. However, immediate reconstruction is more likely than delayed reconstruction to result in complications such as infection, poor surgical incision healing, and tissue breakdown. Poor blood flow in the skin flaps that remain after removal of breast tissue may be the cause of these complications. SPY imaging is a new technology that creates high quality images of blood flow in tissue. It may be able to help reduce these complications by allowing surgeons to identify and eliminate areas of poor blood flow in mastectomy skin flaps. The goal of this trial is to study whether SPY imaging can be used during surgery to improve surgical outcomes for women who are having a mastectomy along with immediate reconstruction with implants.

Meso BioMatrix Device for Breast Reconstruction

Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial (NCT01823107)

Summary

Breast reconstruction after mastectomy is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. Surgeons have recently begun using a mesh derived from human cadaver skin to create a pocket for the tissue expander. The Meso BioMatrix Acellular Peritoneum Matrix is a new mesh that is similar to human skin and recently cleared by the FDA. This is a feasibility trial—a small study to evaluate how this mesh performs during breast reconstruction. The results of this trial, if successful, may be used to design a larger clinical trial in the future.
This is a Phase I-II trial

Determining the Best Time for Reconstruction after Radiation

Effect of Radiation on Tissue for Delayed Breast Reconstruction (NCT01666899)

Summary

The best time to begin breast reconstruction when a patient has both a mastectomy and radiation is not yet known. The purpose of this study is to investigate the effects of radiation therapy following mastectomy by looking at samples taken from skin and blood vessels at various times after mastectomy. The investigators will look at various properties of the skin including its blood flow to determine an ideal time for breast reconstruction.To be eligible, patients must be planning to have a mastectomy, post-mastectomy radiation, and post-mastectomy breast reconstruction.

Smoking Cessation Prior to Mastectomy & Reconstruction

Treatment of Tobacco Dependence in Breast Cancer Patients Scheduled for Mastectomy/Reconstructive Surgery: A Randomized Trial of Varenicline (Chantix) (NCT01532232)

Summary

Breast cancer patients who smoke are at greater risk for treatment complications, especially if they are scheduled for surgery. The purpose of this study is to investigate the effectiveness and impact of varenicline, a prescription medicine also known as Chantix®, in helping breast cancer patients quit smoking. All patients will also receive smoking cessation counseling provided by a tobacco treatment specialist. To be eligible, participants must have smoked an average of 10 cigarettes per day for the past year and be planning to have a mastectomy with reconstruction at Memorial Sloan Kettering Cancer Center in New York City.

Botox to Reduce Pain Caused by Expanders During Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial (NCT01591746)

Summary

Breast reconstruction with implants is typically done in two stages. At the time of surgery, a temporary implant (tissue expander) is inserted, which over the course of several months is slowly filled with saline. A second surgery is then performed to replace the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. BTX-A (Botox) is currently used to reduce pain caused by migraine headaches and chronic tennis elbow as well as for post-operative pain control. This study will assess the safety and effectiveness of using Botox to reduce pain and improve physical well-being during tissue expansion. It is the first time Botox is being studied in breast cancer survivors who are having breast reconstruction with tissue expanders. To be eligible for this study, patients must be scheduled to have breast reconstruction following a skin-sparing or nipple-sparing mastectomy.
This is a Phase III trial