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Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

Phase 4
45 Years
Open (Enrolling)
Malignant Neoplasm of Breast, Breast Radiotherapy, Breast Diseases, Ductal Breast Carcinoma, Intraoperative Radiotherapy

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Trial Information

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

A pragmatic registry trial has been designed and modeled after the original successful,
international TARGIT-A protocol, to continue the use of intraoperative radiotherapy for a
select population of women, and to follow outcomes with regards to local and regional
control, toxicity and morbidity. Within this pragmatic single arm registry trial is a more
selective approach that may be employed in some centers for some or all patients. Patients
selected for breast conserving surgery who are considered to have a low risk of local
recurrence are eligible for the registry trial once given their informed consent.

Inclusion Criteria:

- All patients aged 45 years or older with operable invasive breast cancer, T1 and T2
(< 3.5 cm), N0-1, M0, confirmed by cytological or histological examination, who are
suitable for breast conserving surgery are eligible as long as they have had an
ipsilateral diagnostic mammogram within 12 months of enrollment.

- Those with previously diagnosed and treated contralateral breast cancer may be

- It is recommended that patients meet an ECOG performance status of 0-3, however,
grade 4 patients can be treated at the discretion of the participating center.

- Individual centers 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 the
particular center. For example, centers may decide at outset to recruit only women
over the age of 50 or possibly only postmenopausal women. Before entering any patient
into the trial, the local investigator should confirm that the patient would be
available for regular follow-up for at least 5 years.

Exclusion Criteria:

- Age < 45 years

- Axillary lymph node positive breast cancer

- Invasive lobular cancer

- Tumor size > 3.5 cm

- Extensive Intraductal Component (EIC= > 25% of the lumpectomy specimen involved with
ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy

- Multicentric cancer in the same breast as diagnosed by clinical examination,
mammography, ultrasound. MRI or pathologic assessment, not amenable to excision with
negative margins with a single lumpectomy.

- Inability to assess pathologic margin status

- Bilateral breast cancer at the time of diagnosis.

- Ipsilateral breast had a previous cancer and/or prior in-field radiation.

- Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not

- Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial
treatment with neoadjuvant intent of reducing tumor size.

- No more than 30 days can have elapsed between the last breast cancer surgery (not
axillary) and entry into the trial for patients in the post-pathology stratification.

- Previous history of malignant disease does not preclude entry if the expectation of
relapse-free survival at 10 years is 75% or greater

- Any factor included as exclusion criteria in the participating center's Treatment
Policy Statement.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

In-breast local failure and patterns of in-breast failure

Outcome Description:

Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. Site of relapse within the breast will be recorded in order to assess whether the recurrence is at the site of initial tumor or at a new site and whether it has occurred within the treated field.

Outcome Time Frame:

1 month post-radiation therapy through year 5

Safety Issue:


Principal Investigator

Michael D Alvarado, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSF Carol Franc Buck Breast Care, Department of Surgery


United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Malignant Neoplasm of Breast
  • Breast Radiotherapy
  • Breast Diseases
  • Ductal Breast Carcinoma
  • Intraoperative Radiotherapy
  • Disease-Free Survival
  • Female
  • Humans
  • Intraoperative Care
  • Mastectomy Segmental
  • Middle Aged
  • Neoplasm Recurrence Local
  • Radiotherapy Dosage
  • Radiotherapy Adjuvant
  • Breast Neoplasms
  • Breast Diseases
  • Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast



Northwestern Memorial HospitalChicago, Illinois  60611
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Los Angeles Women's Health Clinic of California Hospital and Medical CenterLos Angeles, California  90015
UCSF Carol Franc Buck Breast Care CenterSan Francisco, California  94115