Node Negative, Invasive Breast Cancer Single Fraction IOERT

Breast Cancer Clinical Trial

Official title: Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Clinical Trial Description

See points VIII inclusion/exclusion criteria

Operation:

• Lumpectomy, steninal node biopsy

• IOeRT

After Surgery:

• Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.

• Chemotherapy (if indicated)

• Hormone therapy (if indicated)

Follow-Up

• Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.

• Assessements of acute toxicity according to CTC-toxicity scoring system

• Assessments of late toxicity according to LENT-SOMA scoring systems

• Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02370797
• Study type: Interventional
• Source: Avera McKennan Hospital & University Health Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2015
• Completion date: May 2029