TARGIT: TARGeted Intraoperative radioTherapy versus postoperative radiotherapy

Phase 3

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN34086741
• Lead Sponsor: niversity College London (UK)

Brief Summary

2001 Results article in http://www.ncbi.nlm.nih.gov/pubmed/11583188 pilot study results 2002 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/12099658 discussion of operative technique 2004 Results article in http://www.ncbi.nlm.nih.gov/pubmed/15574144 Australian results 2005 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16277101 German results 2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16887294 German results on long-term toxicity 2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17084562 results on recurrence rates 2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17826067 international results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27160842 environmental and social benefits results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27689969 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32816842/ long-term results (added 24/08/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34035435/ new insights results (added 27/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-21
• Study Completion: 2012-03-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2298

Inclusion Criteria

Current inclusion criteria as of 17/05/2010:
1. Age 45 years or older
2. Operable invasive breast cancer (T1 and small T2, N0-1, M0) confirmed by cytological or histological examination
3. Suitable for breast conserving surgery
4. Previously diagnosed and treated contralateral breast cancer may be entered but will be randomised to a separate stratum
5. Available for regular follow-up for at least 10 years
Note: Individual centres may wish to restrict entry to a more exactly defined subset of patients, in which case only patients with these characteristics may be entered by that particular centre. For example, centres may decide at outset to recruit only women over 50 or even over 65 years of age. Such policies must be pre-defined in writing and approved by the International Steering Committee.

Previous inclusion criteria:
Eligible patients are those with tumours of good prognosis suitable for breast conserving surgery.

Prior to joining the study, women must meet with the study investigators to determine if they qualify for the TARGIT trial. This evaluation will include a physical examination, review of mammograms and ultrasounds, and review of pathology results. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining eligibility for the study.

In order to participate in the TARGIT trial, the following criteria must be met:
1. Age 40 or older
2. Invasive (also called infiltrating) breast cancer
3. Breast cancer measuring 3 cm (1-1/8 in) or less
4. Breast cancer treatable with lumpectomy
5. Capable of receiving breast radiotherapy (not pregnant, no history of previous radiotherapy to the same breast, no connective tissue disorder)

Exclusion Criteria

Current exclusion criteria as of 17/05/2010:
1. More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography or ultrasonography
2. Bilateral breast cancer at the time of diagnosis
3. Ipsilateral breast had a previous cancer and/or irradiation
4. Patients known to have BRCA2 gene mutations, but testing for gene mutations is not required
5. Lobular cancer or extensive intraductal component (EIC =25% of the tumour is intraductal) on core biopsy or initial pathology (if performed)
6. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumour size should be excluded; those given short duration (up to 4 weeks) systemic therapy can be included
7. Patients presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning. In general, four or more positive nodes or extranodal spread are not suitable for TARGIT alone and should receive EBRT as well. However, individual centres may decide that anything more than micrometastasis should receive EBRT
8. Patients with any severe concomitant disease that may limit their life expectancy
9. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater
10. Any factor included as exclusion criterion in the local centre's Treatment Policy. This is particularly relevant to patients entered into the post-pathology stratum
11. No more than 30 days can have elapsed between last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification

Previous exclusion criteria:
1. Multiple areas of cancer within the breast
2. Cancer in both breasts
3. Diagnostic biopsy shows extensive non-invasive cancer (DCIS or Ductal Carcinoma in Situ)
4. Lymph nodes contain cancer metastasis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 17/05/2010:<br> Local relapse within the treated breast<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added 17/05/2010:<br> 1. Site of relapse within the breast<br> 2. Relapse-free survival and overall survival<br> 3. Local toxicity/morbidity<br>