TARGIT-US Trial

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Background

The Targeted Intraoperative Radiotherapy United States phase IV trial (TARGIT-US Trial) studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. 


Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.



Eligibility

Study Status: THIS STUDY IS NOW CLOSED TO ENROLLMENT.  WE ARE CONTINUING TO FOLLOW THE PATIENTS FOR LONG-TERM OUTCOMES. 


Inclusion Criteria:

  • Suitable for breast conserving surgery
  • T1 and T2 (< 3.5 cm), N0, M0

Exclusion Criteria:

  • 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), as assessed on surgical pathologic lumpectomy specimen
  • Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
  • Inability to assess pathologic margin status
  • Synchronous 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 required)
  • Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
  • Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
  • Any factor included as exclusion criteria in the participating center's treatment policy statement
  • Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):
    • Patients under the age of 50
    • Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
    • HER2 positive (as defined in Treatment Policy under "HER2")
    • Lymphovascular invasion
    • High grade
    • Tumors > 3 cm
    • Node positive patients
    • Prior chemotherapy or hormone therapy

Sponsors and Collaborators

University of California, San Francisco

Clinical Trials.gov Identifier

NCT01570998

Study Contact

Allison Zimmerman

Research Coordinator

Helen Rey Breast Cancer Research Foundation

Telephone: 818-539-1985 FAX: 818-539-1985