N/A
N=1,133
TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01440010 ↗Enrolled (actual)
1,133
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Number of Patients With Local Recurrence — 10 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- IORT with 20 Gy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Universitätsmedizin Mannheim
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Local Recurrence |
10 | — |
| SECONDARY Percentage of Patients With Chronic Higher Grade Fibrosis After IORT Boost |
132 | — |
Summary
Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT
Eligibility Criteria
Inclusion Criteria
- Tumor diameter 3,5 cm
- No indication for a boost
Data sourced from ClinicalTrials.gov (NCT01440010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.