Status:
ACTIVE_NOT_RECRUITING
TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer
Lead Sponsor:
Universitätsmedizin Mannheim
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study. Patients ≥ 50 years with small, low-risk breast cancer who are oper...
Detailed Description
1. Introduction Randomized studies provide evidence that concerning the overall survival breast conserving surgery (BCS) combined with postoperative radiotherapy is equally effective as modified m...
Eligibility Criteria
Inclusion
- histologically verified invasive-ductal breast cancer
- hormone receptor positive (if known)
- cT1 or small cT2 (≤ 3.5 cm) cN0 cM0
- ≥ 50 years of age
- informed consent
- compliance
Exclusion
- extensive intraductal component (EIC)
- negative hormone receptor status
- multifocality /-centricity (mammography, breast ultrasound)
- lymph vessel invasion (L1)
- clinical signs of distant metastases or clinically suspicious lymph nodes
- other histology
- \< 50 years
- missing informed consent or non-compliance
- bilateral breast cancer at the time of diagnosis
- known BCRA1/2 gene mutations (genetic testing not required)
- any exclusion criterion in the local centre´s treatment policy
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT02290782
Start Date
October 1 2014
End Date
December 1 2026
Last Update
March 26 2025
Active Locations (4)
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1
Institut régional du Cancer de Montpellier
Montpellier, France, 34298
2
IUCT, Toulouse
Toulouse, France
3
Klinikum Kassel
Kassel, Germany, 34125
4
Department of Radiotherapy University Hospital Mannheim
Mannheim, Germany, 68167