An interventional study of intraoperative radiotherapy in Breast Neoplasms, Breast Diseases and Neoplasm Recurrence, Local, sponsored by Universitätsmedizin Mannheim. Completed at 1 site in Germany. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Universitätsmedizin Mannheim · Not applicable, Interventional, and Treatment
This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 591 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single arm with intraoperative radiotherapy
Radiation: intraoperative radiotherapy
intraoperative single dose radiotherapy (20 Gy)
Also known as: IORT
Local Relapse
Rate of local relapse (within 2cm of the initial tumor bed)
Time frame: up to ten years
Overall Survival
Death is an event
Time frame: up to ten years
Ipsi- or Contralateral Breast Cancer
Rate of ipsilateral and contralateral breast cancer events
Time frame: up to ten years
Cosmesis
BCCT.Core analysis of cosmesis
Time frame: up to 7.5 years
General and breast-specific Quality of Life after IORT
EORTC questionnaires QLQ C30 and BR23
Time frame: up to 10 years
Late toxicity after IORT
LENT-SOMA based toxicity at all FU time points
Time frame: up to ten years
Plan to share: No — It was not planned initially back in 2011.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Universitätsmedizin Mannheim