Breast CancerNCT00556907
Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast
A study testing Intraoperative radiotherapy in people with Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intraoperative radiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Intraoperative radiotherapy
- Keywords
- DCIS, To evaluate Preoperative mammagraphy and MRI to select candiates with DCIS for IORT
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative radiotherapyRadiation
Also called Intrabeam Photon Radiosurgery System and Applicators
20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Intraoperative radiotherapyDevice
Also called Intrabeam Photon Radiosurgery
20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients will receive IORT Receives: Radiation: Intraoperative radiotherapy; Device: Intraoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Number of Serious Adverse Events.
Assessment of the overall serious adverse event rate.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2015
- Study completionNov 2016
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Macdonald, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556907
- Sponsor's protocol ID
- 1B-06-9
- Status last verified
- Oct 2025
- First submitted
- 8 Nov 2007
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 34459500
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00556907
- Acronym / sponsor ID
- 1B-06-9
- Conditions
- Breast Cancer
- Keywords
- DCIS, To evaluate Preoperative mammagraphy and MRI to select candiates with DCIS for IORT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Intraoperative radiotherapy, Device: Intraoperative radiotherapyPatients will receive IORT |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- All cohorts
- Signed informed consent and HIPAA documents
- Female sex
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative radiotherapyAlso: Intrabeam Photon Radiosurgery System and Applicators20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed | Radiation | 1 |
| Intraoperative radiotherapyAlso: Intrabeam Photon Radiosurgery20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed | Device | 1 |
Primary outcome
Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT
Time frame: 30 days
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.
1 secondary outcome
Number of Serious Adverse Events.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34459500Hickey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Macdonald, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative radiotherapy in people with Breast Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.