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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00392184
First received: October 24, 2006
Last updated: May 29, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention Phase
Breast Cancer
Procedure: Accelerated partial breast irradiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Enrollment: 274
Study Start Date: November 2000
Study Completion Date: October 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APBI
Accelerated Partial Breast Irradiation with interstitial Brachytherapy
Procedure: Accelerated partial breast irradiation

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392184

Locations
Austria
Hospital Barmherzige Schwestern Linz
Linz, Austria
University Hospital AKH Vienna
Vienna, Austria, 1090
Germany
University Hospital Erlangen
Erlangen, Germany, 91052
University Hospital Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Chair: Vratislav Strnad, MD University Hospital Erlangen, Germany
Study Director: Oliver J Ott, MD University Hospital Erlangen, Germany
Principal Investigator: Guido Hildebrandt, MD University Hospital Leipzig, Germany
Principal Investigator: Richard Pötter, MD University Hospital AKH Vienna, Austria
Principal Investigator: Joe Hammer, MD Hospital Barmherzige Schwestern Linz, Austria
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00392184     History of Changes
Other Study ID Numbers: German-Austrian APBI Trial
Study First Received: October 24, 2006
Last Updated: May 29, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
accelerated partial breast irradiation
multicatheter brachytherapy
high dose rate brachytherapy
pulsed dose rate brachytherapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on September 02, 2015