Full TitlePhase II Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions Back to top
Women who have a mastectomy as treatment for locally advanced breast cancer may need radiation therapy afterward. But in women who received a breast implant (a tissue expander or permanent implant) as part of breast reconstruction, the radiation may damage the implant. In this study, researchers are evaluating the effectiveness of a different form of radiation therapy for these patients to see if it results in fewer complications.
With the standard method, three-dimensional radiation is delivered using two to five radiation beams. With the investigational method being assessed in this study, eight to twelve small radiation beams will be delivered through an approach called multi-beam intensity-modulated radiation therapy (IMRT). This method enables highly tailored radiation to be given to the implant, breast, chest wall, and lymph nodes. Multi-beam IMRT may also lower the radiation dose to the heart, lungs, and other nearby healthy tissues.Back to top
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have locally advanced breast cancer that was treated with mastectomy followed by reconstruction with an implant (tissue expander or permanent implant).
- Patients should be scheduled for radiation therapy.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is open to patients age 18 and older.