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Breast NeoplasmsTARGIT-ENCT01299987

Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer

A study testing intraoperative radiotherapy in people with Breast Neoplasms and Breast Diseases, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 70 years and older, women only
What is being tested?
intraoperative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
591 participants
Where
1 siteGermany
Study dates
Jan 2011to Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • cT1c cN0 cM0
  • ≥ 70 years old
  • invasive-ductal histology
  • compliance
  • informed consent

Who cannot join

  • 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
Show all 9Show fewer
  • missing informed consent or non-compliance
  • bilateral breast cancer at time of diagnosis
  • known BRACA 1/2 mutations (genetic testing not required)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsmedizin Mannheim UMM

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

About this study

Official title: TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer

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.

Read the detailed description

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.

Being tested
intraoperative radiotherapy
Keywords
Keywords provided by University Hospital Mannheim:, Intraoperative Radiotherapy, Early Breast Cancer, Elderly Patients
Medical subject headings
Breast Neoplasms, Breast Diseases, Neoplasm Recurrence, Local, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intraoperative radiotherapyRadiation

    Also called IORT

    intraoperative single dose radiotherapy (20 Gy)

Study groups in NCT01299987
Study groupRoleWhat they receive
Intraoperative radiotherapyExperimentalsingle arm with intraoperative radiotherapy
Receives: Radiation: intraoperative radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local Relapse

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

    Measured: up to ten years

Secondary outcomes (5)

  1. Overall Survival

    Death is an event

    Measured: up to ten years

  2. Ipsi- or Contralateral Breast Cancer

    Rate of ipsilateral and contralateral breast cancer events

    Measured: up to ten years

  3. Cosmesis

    BCCT.Core analysis of cosmesis

    Measured: up to 7.5 years

  4. General and breast-specific Quality of Life after IORT

    EORTC questionnaires QLQ C30 and BR23

    Measured: up to 10 years

  5. Late toxicity after IORT

    LENT-SOMA based toxicity at all FU time points

    Measured: up to ten years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionNov 2022
  4. Study completionNov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01299987
Sponsor's protocol ID
TARGIT-E
Acronym
TARGIT-E
Status last verified
Mar 2025
First submitted
18 Feb 2011
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: It was not planned initially back in 2011.

Publications

  • Sperk E, Lemanski C, Neumaier C, Lauer J, Siefert V, Volker R, Lindner C, Niehoff P, Tallet AR, Racadot S, Petit A, Pazos M, Le-Blanc Onfroy M, Martin E, Reuter C, Hermann RM, Pohl F, Friedrichs K, Wurschmidt F, Pigorsch S, Kolberg HC, Graf H, Brunner TB, Malter W, Park-Simon TW, Brucker C, Fleckenstein J, Petersen C, Tuschy B, Wilken EE, Buttner S, Sutterlin M, Flyger H, Wenz F. Intraoperative radiotherapy in elderly patients with breast cancer: long-term follow-up results of the prospective phase II trial TARGIT-E. BMC Cancer. 2025 Dec 4;25(1):1862. doi: 10.1186/s12885-025-15289-0.

    PubMed 41345599

  • Neumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171.

    PubMed 22569123

Questions about this trial

What is this clinical trial studying?

A study testing intraoperative radiotherapy in people with Breast Neoplasms and Breast Diseases, run by Universitätsmedizin Mannheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Relapse (time frame: up to ten years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01299987, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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