Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast

Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast (TARGIT-DCIS Trial): Use of Mammography and Breast MRI to Identify Candidates for IORT.

We hypothesize that the combination of mammography and CE-MRI will improve the surgeon and radiologist's ability to define extent of disease prior to surgical resection, improve the odds of obtaining clear surgical margins, and increase the efficacy of IORT delivered immediately after initial surgical resection. In this investigation, we will determine whether or not patients deemed eligible for 'immediate" IORT based on mammography and CE-MRI can be successfully treated without the need for re-excision or additional radiotherapy due to inadequate surgical margins.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Intraoperative radiotherapy; Device: Intraoperative radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with biopsy-proven DCIS, mammographic and CE-MRI evidence of DCIS measuring great then equal to 4cm, and a desire to receive breast conserving therapy, will be considered for participation in this study.
• Patient history, physical examination findings, and demographics (sex, age, height, weight, bra size, etc.) will be performed and documented.

Inclusion Criteria for Initial Registration (all patients cohorts):

All cohorts

• Signed informed consent and HIPAA documents
• Female sex
• Age great then equal to 40 years
• Localized ductal carcinoma in situ
• Clinically and/or histologically negative axillary lymph nodes
• No imaging or clinical findings suggestive of invasive carcinoma.

Cohort 1 (Immediate IORT group)

• Localized DCIS measuring less then equal to 4 cm on preoperative imaging.
• Cohort 2 (Delayed IORT group)
• Localized DCIS measuring less then equal to4 cm or less on surgical pathology
• Delayed IORT could be performed for the explicit purpose of administering IORT or performed following re-excision of a previously operated breast to achieve clear surgical margins.
• This cohort includes patients who were excluded from immediate IORT based on pre-operative imaging suggesting ineligibility for immediate IORT, but who are subsequently found to meet histological criteria (localized DCIS less then equal to 4 cm and no invasive cancer) for IORT based on surgical pathology.
• Unifocal microinvasive (T1mic or invasive focus less then equal to 1mm in maximal diameter) is allowed following initial WLE if surgical pathology margins were less then equal to2 mm for both the invasive and non-invasive components.
• Delayed IORT must be performed within 3 months of initial WLE.
• Cohort 3 Subjects who received IORT at the time of initial WLE but whose surgical pathology showed them to be unsuitable candidates for IORT alone on the basis of:
• DCIS measuring greater than 5 cm on surgical pathology.
• T1a (less than 1 mm) or larger invasive carcinoma associated with extensive DCIS.
• Surgical margins width less than1 mm.

Exclusion Criteria:

• Male sex
• Age less than 40
• DCIS associated with any evidence of microinvasion or invasive carcinoma on pre-operative imaging or core biopsy of the breast or axillary nodes.
• DCIS that is multicentric in the ipsilateral breast. Multicentricity will be defined at 2 or more lesions separated by more than 3 cm in the same breast.
• Non-epithelial breast malignancies such as sarcoma or lymphoma
• DCIS associated with diffuse suspicious or indeterminate microcalcifications
• Pregnancy or lactation
• Collagen vascular diseases, including Systemic lupus erythematosus, Systemic sclerosis (scleroderma), CREST Syndrome (calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, telangiectasia, and the presence of anticentromere antibodies), polymyositis, dermatomyositis with a CPK level above normal or with an active skin rash, inclusion-body myositis, or amyloidosis
• Serious psychiatric or addictive disorders

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
Other: 1; Patients will receive IORT	Radiation: Intraoperative radiotherapy; 20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed; Other Names: Intrabeam Photon Radiosurgery System and Applicators; Device: Intraoperative radiotherapy; 20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed; Other Names: Intrabeam Photon Radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT	These are the rates of reoperation for re-excision or mastectomy following Wide Local Excision (WLE) or Intraoperative Radiation Therapy (IORT). The number of patients who required reoperation were reported below.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events.	Assessment of the overall serious adverse event rate.	2 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Heather Macdonald, MD, University of Southern California

Publications and helpful links

General Publications

• Hickey BE, Lehman M. Partial breast irradiation versus whole breast radiotherapy for early breast cancer. Cochrane Database Syst Rev. 2021 Aug 30;8(8):CD007077. doi: 10.1002/14651858.CD007077.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2007
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 8, 2007
• First Submitted That Met QC Criteria: November 9, 2007
• First Posted (Estimated): November 12, 2007

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: DCIS; To evaluate Preoperative mammagraphy and MRI to select candiates with DCIS for IORT
• Additional Relevant MeSH Terms: Breast Carcinoma In Situ; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Skin and Connective Tissue Diseases; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: 1B-06-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes