TARGIT-A Trial

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Background

The purpose of this study is to evaluate whether a single fraction of radiotherapy given intra-operatively and targeted to the tissues at the highest risk of local recurrence is equivalent to standard post-operative external beam radiotherapy after breast conserving surgery in women with early stage breast cancer in terms of local relapse within the treated breast. This study has ended recruitment. 

Eligibility

Study Status: THIS STUDY IS NOW CLOSED TO ENROLLMENT.  THE FINAL RESULTS HAVE BEEN SUBMITTED FOR PUBLICATION.  


Inclusion criteria

  • Age 45 years or older
  • Operable invasive breast cancer (T1 and small T2, N0-1, M0) confirmed by cytological or histological examination
  • Suitable for breast conserving surgery
  • Previously diagnosed and treated contralateral breast cancer may be entered but will be randomized to a separate stratum.
  • Available for regular follow-up for at least ten years.

Exclusion criteria

  • More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography or ultrasonography.
  • Bilateral breast cancer at the time of diagnosis.
  • Ipsilateral breast had a previous cancer and/or irradiation.
  • Patients known to have BRCA2 gene mutations, but testing for gene mutations is not required
  • Lobular cancer or Extensive intraductal Component (EIC =>25% of the tumour is intraductal) on core biopsy or initial pathology (if performed)
  • Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumor size should be excluded; those given short duration (up to 4 weeks) systemic therapy can be included.
  • Patients presenting with gross nodal disease, considered to be clinically malignant or proven cytologically or by scanning. In general, 4 or more positive nodes or extranodal spread are not suitable for Targit alone and should receive EBRT as well. However, individual centers may decide that anything more than micrometastasis should receive EBRT.
  • Patients with any severe concomitant disease that may limit their life expectancy.
  • Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
  • Any factor in the Treatment Policy. This is particularly relevant to patients entered into the post pathology stratum.
  • 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.

Sponsors and Collaborators

University College London

National Institute for Health Research, United Kingdom

ClinicalTrials.gov Identifier:

 NCT00983684

Study Contact

Allison Zimmerman

Helen Rey Breast Cancer Research Foundation

Telephone: 818-539-1985 Fax: 818-539-1985