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TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer

Phase 2
70 Years
Open (Enrolling)
Breast Neoplasms, Breast Diseases, Neoplasm Recurrence, Local, Neoplasms

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Trial Information

TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer

Patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated
show local relapse rates around 4% after 4 years. With adjuvant whole breast radiotherapy
(WBRT) the local relapse rate drops to 1% after 4 years under Tamoxifen (Hughes et al 2004).
It has been demonstrated (Polgar et al. 2007, Vaidya et al. 2010) that the efficacy of
radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT
E study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT)
in a well selected group of elderly patients with small breast cancer and absence of risk
factors. In presence of risk factors postoperative WBRT will be added to complete the
radiotherapeutic treatment according to international guidelines.

Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse,
cancer-specific and overall survival and contralateral breast cancer as well as
documentation of quality of life and cosmetic outcome. The expected local relapse rates are
0.5/1/1.5% after 2.5/5/7.5 years, respectively.

Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6%
after 2.5/5/7.5 years. Power calculations result in 265 patients with a calculated loss to
follow-up of 20%, an alpha of 0.05 and a beta 0.1. Only centers with access to the
Intrabeam® system (Carl Zeiss) can recruit patients into the trial.

Inclusion Criteria:

- cT1c cN0 cM0

- ≥ 70 years old

- invasive-ductal histology

- compliance

- informed consent

Exclusion Criteria:

- extensive intraductal component (EIC)

- multifocality /-centricity

- lymph vessel invasion (L1)

- clinical signs of distant metastases or clinically suspicious lymph nodes

- other histology

- < 70 years old

- missing informed consent or non-compliance

- bilateral breast cancer at time of diagnosis

- known BRACA 1/2 mutations (genetic testing not required)

Type of Study:


Study Design:

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

Outcome Measure:

Local Relapse

Outcome Description:

Rate of local relapse (within 2cm of the initial tumor bed)

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Frederik Wenz, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Center Mannheim


Germany: Federal Office for Radiation Protection

Study ID:




Start Date:

January 2011

Completion Date:

November 2025

Related Keywords:

  • Breast Neoplasms
  • Breast Diseases
  • Neoplasm Recurrence, Local
  • Neoplasms
  • Keywords provided by University Hospital Mannheim:
  • Intraoperative Radiotherapy
  • Early Breast Cancer
  • Elderly Patients
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms
  • Neoplasm Recurrence, Local
  • Recurrence