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

Phase 2

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT01008514
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2009-11-04
• Study First Submitted QC: 2009-11-04
• Study First Posted: 2009-11-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

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