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

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Accelerated partial breast irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00392184

German-Austrian APBI Trial

Details and patient eligibility

About

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

Enrollment: 274 patients

Sex: Female

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

274 participants in 1 patient group

APBI

Experimental group

Description:

Accelerated Partial Breast Irradiation with interstitial Brachytherapy

Treatment:

Procedure: Accelerated partial breast irradiation