Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Accelerated partial breast irradiation

• Registration Number: NCT00392184
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

The purpose of this study is to determine whether accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy is safe and effective.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-25
• Primary Completion: 2009-02
• Study Completion: 2010-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 274

Inclusion Criteria

• pT1/2 (≤ 3 cm)
• pN0 or pN1 mi
• M0 and no contralateral BC
• Clear margins (≥ 2 mm)
• Age ≥ 35 years
• ER and/or PR positive

Exclusion Criteria

• Multifocality or Multicentricity
• EIC
• Lymphovascular invasion
• Poorly differentiated tumors
• Diffuse microcalcifications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APBI	Accelerated partial breast irradiation	Accelerated Partial Breast Irradiation with interstitial Brachytherapy

Trial Locations

Locations (4)

University Hospital AKH Vienna; 🇦🇹 Vienna, Austria

Hospital Barmherzige Schwestern Linz; 🇦🇹 Linz, Austria

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

University Hospital Leipzig; 🇩🇪 Leipzig, Germany