Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT01008514
- Brief Summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
Secondary
* To assess the toxicities associated with MammoSite® RTS in these patients.
* To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
* To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
* To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of local recurrence up to 5 years * Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume.
* Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.
- Secondary Outcome Measures
Name Time Method Safety and toxicity up to 30 months after radiotherapy Cosmetic results up to 30 months