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Clinical Trials/NCT00392184
NCT00392184
Completed
Phase 2

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

University of Erlangen-Nürnberg Medical School4 sites in 2 countries274 target enrollmentNovember 2000
ConditionsBreast Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
274
Locations
4
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2000
End Date
October 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

Eligibility 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
  • Lymphovascular invasion
  • Poorly differentiated tumors
  • Diffuse microcalcifications

Outcomes

Primary Outcomes

Not specified

Study Sites (4)

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