NCT00392184

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_2 breast-cancer

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

8.3 years

First QC Date

October 24, 2006

Last Update Submit

May 29, 2015

Conditions

Breast Cancer

Keywords

accelerated partial breast irradiationmulticatheter brachytherapyhigh dose rate brachytherapypulsed dose rate brachytherapy

Study Arms (1)

APBI

EXPERIMENTAL

Accelerated Partial Breast Irradiation with interstitial Brachytherapy

Procedure: Accelerated partial breast irradiation

Interventions

Accelerated partial breast irradiationPROCEDURE
APBI

Eligibility Criteria

Age35 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Barmherzige Schwestern Linz

Linz, Austria

Location

University Hospital AKH Vienna

Vienna, 1090, Austria

Location

University Hospital Erlangen

Erlangen, 91052, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Related Publications (4)

  • Ott OJ, Potter R, Hammer J, Hildebrandt G, Lotter M, Resch A, Pohls 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 trial. Strahlenther Onkol. 2004 Oct;180(10):642-9. doi: 10.1007/s00066-004-1294-2.

    PMID: 15480513RESULT

  • Strnad V, Ott O, Potter 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. 2004;3(3):115-9. doi: 10.1016/j.brachy.2004.08.003.

    PMID: 15533801RESULT

  • Ott OJ, Potter 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. doi: 10.1055/s-2005-858268. German.

    PMID: 15973598RESULT

  • Ott OJ, Hildebrandt G, Potter R, Hammer J, Hindemith M, Resch A, Spiegl K, Lotter M, Uter W, Kortmann RD, Schrauder M, Beckmann MW, Fietkau R, Strnad V. Accelerated partial breast irradiation with interstitial implants: risk factors associated with increased local recurrence. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1458-63. doi: 10.1016/j.ijrobp.2010.04.032. Epub 2010 Aug 2.

    PMID: 20675064DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Vratislav Strnad, MD

    University Hospital Erlangen, Germany

    STUDY CHAIR

  • Oliver J Ott, MD

    University Hospital Erlangen, Germany

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

November 1, 2000

Primary Completion

February 1, 2009

Study Completion

October 1, 2010

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

AU(2)DE(2)