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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392184
• Other study ID #: German-Austrian APBI Trial
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2006
• Last updated: May 29, 2015
• Start date: November 2000
• Est. completion date: October 2010

Study information

• Verified date: May 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: October 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Accelerated partial breast irradiation

Locations

Country	Name	City	State
Austria	Hospital Barmherzige Schwestern Linz	Linz
Austria	University Hospital AKH Vienna	Vienna
Germany	University Hospital Erlangen	Erlangen
Germany	University Hospital Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (3)

Ott OJ, Pötter R, Hammer J, Hildebrandt G, Lotter M, Resch A, Pöhls U, Beckmann MW, Sauer R, Strnad V. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter tria — View Citation

Ott OJ, Pötter R, Hildebrandt G, Hammer J, Lotter M, Beckmann MW, Sauer R, Strnad V. [Partial breast irradiation for early breast cancer with favorable prognostic factors: 3-year results of the German-Austrian phase II-trial]. Rofo. 2005 Jul;177(7):962-7. — View Citation

Strnad V, Ott O, Pötter R, Hildebrandt G, Hammer J, Resch A, Lotter M, Ackermann S, Beckmann MW, Sauer R. Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial. Brachytherapy. 200 — View Citation