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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

October 24, 2006
May 29, 2015
November 2000
February 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00392184 on ClinicalTrials.gov Archive Site
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Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving Surgery
The purpose of this study is to determine whether accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy is safe and effective.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Procedure: Accelerated partial breast irradiation
Experimental: APBI
Accelerated Partial Breast Irradiation with interstitial Brachytherapy
Intervention: Procedure: Accelerated partial breast irradiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
October 2010
February 2009   (final data collection date for primary outcome measure)

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
Female
35 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00392184
German-Austrian APBI Trial
No
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University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
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
University of Erlangen-Nürnberg Medical School
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP