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TARGIT: A Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy With Conventional Post-operative Radiotherapy After Conservative Breast Surgery for Women With Early Stage Breast Cancer

Phase 3
45 Years
Not Enrolling
Invasive Breast Cancer, Breast Cancer

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Trial Information

TARGIT: A Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy With Conventional Post-operative Radiotherapy After Conservative Breast Surgery for Women With Early Stage Breast Cancer

TARGIT is an international randomised clinical trial designed to test the hypothesis that
the strategy of delivering a single dose of targeted intraoperative radiotherapy (IORT) in
patients eligible for breast conserving therapy (with the addition of whole breast
radiotherapy in those patients at high risk of recurrence elsewhere in the breast [e.g.
lobular carcinomas and extensive intraductal component]) is equivalent to a conventional
course of post-operative external beam radiotherapy (EBRT). The primary endpoints are local
and loco-regional recurrence rates. It is a pragmatic trial in which each participating
centre has the option to define more restrictive entry criteria than in the core protocol.
Only centres with access to the Intrabeam® (Carl Zeiss) enter patients into the trial.
Eligible patients are those with tumours of good prognosis suitable for breast conserving
surgery. After giving consent patients are randomised to either IORT or to EBRT. They may
receive any other adjuvant treatments as deemed necessary, except for neoadjuvant therapy.
The protocol requires that patients be followed at six monthly intervals for five years and
then annually.

Inclusion Criteria

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 randomised to a separate stratum.

- Available for regular follow-up for at least ten 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.

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

- 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 tumour 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 centres 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 included as exclusion criterion in the local centre's 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local relapse within the treated breast.

Outcome Time Frame:

3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months

Safety Issue:


Principal Investigator

Jeffrey S Tobias, MD FRCP FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals


United Kingdom: Research Ethics Committee

Study ID:

ISRCTN 34086741



Start Date:

March 2000

Completion Date:

June 2012

Related Keywords:

  • Invasive Breast Cancer
  • Breast Cancer
  • Neoplasms by Site
  • Breast Neoplasms
  • Breast Diseases
  • Breast Cancer
  • Cancer of Breast
  • Cancer of the Breast
  • Carcinoma
  • Breast Neoplasms