NCT01008514

Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer

A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	adjuvant therapy
RADIATION	accelerated partial breast irradiation
RADIATION	intracavitary balloon brachytherapy

Timeline

• First posted: 2009-11-05
• Last updated: 2015-03-26