NCT01440010: TARGIT_BQR

TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

Completed Results posted Last updated 12 December 2025

What this trial tests

trial testing IORT with 20 Gy in Breast Cancer in 1,133 participants. Completed in 31 December 2020.

Timeline

1 September 2011

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Universitätsmedizin Mannheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,133
Start date	1 September 2011
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across Germany

Drugs / interventions tested

• IORT with 20 Gy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Universitätsmedizin Mannheim — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Local Recurrence Primary · 5 years

The follow-up was carried out every six months for the first two years, and then once a year. The follow-up always included a mammography in addition to a clinical examination. Kaplan-Meier-estimates were done to calculate the local recurrence rate

Group	Value	95% CI
IORT Boost	10

Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost Secondary · 84 months

Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) and oncological data took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs).

Group	Value	95% CI
IORT Boost	132

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IORT Boost With 20 Gy and Standard Whole Breast Irradition

Serious: 0/902 (0%)

Deaths: 16/902

Other adverse events (2 terms — click to expand)

Reaction	System	IORT Boost With 20 Gy and …
Palpable seroma	Skin and subcutaneous tissue disorders	—
Erythema	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT01440010 adverse events section.

Sponsor's own description

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer.
   Sperk E, Astor D, Keller A, Welzel G, et al · · 2014 · cited 16× · PMID 25015740 · DOI 10.1186/1748-717x-9-154
2. Longitudinal cosmetic outcome after planned IORT boost with low kV X-rays-monocentric results from the TARGIT BQR registry.
   Goerdt L, Poemsl J, Spaich S, Welzel G, et al · · 2023 · cited 4× · PMID 37588731 · DOI 10.21037/tcr-23-88
3. Acute and Long-Term Toxicity after Planned Intraoperative Boost and Whole Breast Irradiation in High-Risk Patients with Breast Cancer-Results from the Targeted Intraoperative Radiotherapy Boost Quality Registry (TARGIT BQR).
   Goerdt L, Schnaubelt R, Kraus-Tiefenbacher U, Brück V, et al · · 2024 · cited 3× · PMID 38893184 · DOI 10.3390/cancers16112067
4. Long-term cosmetic outcome after intraoperative radiotherapy boost with low-energy X-rays in breast-conserving therapy: a pooled cohort analysis of the TARGIT-BQR and ROKSM trials.
   Schimmelfennig P, Reuter C, Kraus-Tiefenbacher U, Brück V, et al · · 2026 · PMID 41627394 · DOI 10.1007/s00066-026-02506-3
5. Oncological outcomes of breast cancer patients after planned IORT boost with low-kV x-rays-results of the TARGIT BQR prospective phase IV trial.
   Goerdt L, Pömsl J, Kraus-Tiefenbacher U, Brück V, et al · · 2026 · PMID 40387868 · DOI 10.1007/s00066-025-02412-0