Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

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

This phase IV 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage IA Breast Cancer; Stage IIA Breast Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Radiation: Intraoperative Radiation Therapy

Detailed Description

PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE:

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

• Study Type: Interventional
• Enrollment (Actual): 1259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Medical Center-Herrick Campus
    • Irvine, California, United States, 92617
      • University of California, Irvine
    • Los Angeles, California, United States, 90015
      • Dignity Health - California Hospital Medical Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • Walnut Creek, California, United States, 94598
      • John Muir Medical Center-Walnut Creek
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Fort Lauderdale, Florida, United States, 33308
      • Cleveland Clinic
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Community Cancer Center South
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Marie Yeager Cancer Center, Spectrum Health Lakeland
  • New York
    • Dobbs Ferry, New York, United States, 10522
      • Community Hospital at Dobbs Ferry
    • Ithaca, New York, United States, 14850-2488
      • Cornell University
    • New York, New York, United States, 10032
      • Columbia University/Herbert Irving Cancer Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Saint Luke's Hospital-Anderson Campus
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Fairfax Hospital Cancer Center
    • Newport News, Virginia, United States, 23606
      • Sentara Port Warwick
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Axillary lymph node positive breast 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")
  • Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
  • Lymphovascular invasion
  • High grade
  • Tumors > 3 cm
  • Node positive patients
  • Prior chemotherapy or hormone therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (IORT); Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.	Other: Laboratory Biomarker Analysis; Correlative studies; Radiation: Intraoperative Radiation Therapy; Undergo IORT; Other Names: IORT; Intraoperative Radiotherapy; radiotherapy, intraoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of local recurrence	Local tumor control is defined as no recurrent tumor in the ipsilateral breast. 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. The two patient cohorts will not be separated for the analysis regarding local control.	Up to 5 years
Frequency of site of relapse within the breast	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 (IORT).	Up to 5 years
Percentage of participants with treatment-related adverse events	Local toxicity and morbidity will be recorded as adverse events related to the primary treatment of the breast cancer. These were recorded in the randomized trial and outcomes showed no significant difference in clinical complications for the IORT as compared to standard external beam radiation. However, all expected toxicities of hematoma, seroma, wound infection, wound breakdown and delayed wound healing will be assessed according to Radiation Therapy Oncology Group (RTOG) criteria. Late skin reactions, rash, telangiectasia and pain due to radiation and all other toxicities will be recorded and graded according to standard NCI-CTCAE V. 4 criteria	Up to 5 years
Median Relapse-free survival	Relapse-free survival will be recorded as the time interval between trial entry and the date of confirmation of any recurrence. The actual date to be used is the clinic day on which the investigations that led to a confirmed diagnosis of the recurrence were requested. Relapse-free survival would include any recurrence of breast cancer (local, regional or distant) or death without prior report a relapse. All patients will be analyzed under an "Intent to Treat" policy	Up to 5 years
Median Overall Survival	Overall survival will be the time interval between enrollment and death.	Up to 5 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Carl Zeiss Meditec AG
• Investigators: Principal Investigator: Michael Alvarado, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2012
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 2, 2012
• First Submitted That Met QC Criteria: April 2, 2012
• First Posted (Estimated): April 4, 2012

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Radiotherapy
• Other Study ID Numbers: 117515; NCI-2017-00461 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes