Stage IA Breast CancerNCT01570998
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
A study testing Intraoperative Radiation Therapy and Laboratory Biomarker Analysis in people with Stage IA Breast Cancer and Stage IIA Breast Cancer, run by University of California, San Francisco at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Stage IA Breast Cancer, Stage IIA Breast Cancer
- What is being tested?
- Intraoperative Radiation Therapy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,259 participants
- Where
- 25 sitesUnited States
- Study dates
- 18 May 2012to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable for breast conserving surgery
- T1 and T2 (< 3.5 cm), N0, M0
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Mercy Medical Center
Baltimore, Maryland, 21202
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Northwestern University
Chicago, Illinois, 60611
Community Hospital at Dobbs Ferry
Dobbs Ferry, New York, 10522
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045
Inova Fairfax Hospital Cancer Center
Fairfax, Virginia, 22031
Cleveland Clinic
Fort Lauderdale, Florida, 33308
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Greenwich Hospital
Greenwich, Connecticut, 06830
Community Cancer Center South
Indianapolis, Indiana, 46227
University of California, Irvine
Irvine, California, 92617
Cornell University
Ithaca, New York, 14850-2488
Dignity Health - California Hospital Medical Center
Los Angeles, California, 90015
Loyola University Medical Center
Maywood, Illinois, 60153
Columbia University/Herbert Irving Cancer Center
New York, New York, 10032
Sentara Port Warwick
Newport News, Virginia, 23606
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Marie Yeager Cancer Center, Spectrum Health Lakeland
Saint Joseph, Michigan, 49085
University of California, San Francisco
San Francisco, California, 94143
Memorial Health University Medical Center
Savannah, Georgia, 31404
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Stage IA Breast Cancer, Stage IIA Breast Cancer
- Being tested
- Intraoperative Radiation Therapy, Laboratory Biomarker Analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Radiation TherapyRadiation
Also called Intraoperative Radiotherapy, IORT, radiotherapy, intraoperative
Undergo IORT
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (IORT) | Experimental | Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy. Receives: Radiation: Intraoperative Radiation Therapy; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: Up to 5 years
Median Overall Survival
Overall survival will be the time interval between enrollment and death.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study start18 May 2012
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 1,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec AG
- Responsible party
- Sponsor
- Investigators
- Michael Alvarado, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570998
- Sponsor's protocol ID
- 117515
- Other IDs
- NCI-2017-00461
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2012
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
- ClinicalTrials.gov ID
- NCT01570998
- Acronym / sponsor ID
- 117515
- Conditions
- Stage IA Breast Cancer, Stage IIA Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,259 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec AG
- Study start
- 18 May 2012 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (IORT) | Experimental | Radiation: Intraoperative Radiation Therapy, Other: Laboratory Biomarker AnalysisPatients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suitable for breast conserving surgery
- T1 and T2 (< 3.5 cm), N0, M0
Key exclusion criteria (20 listed)
- 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
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 Radiation TherapyAlso: Intraoperative Radiotherapy, IORT, radiotherapy, intraoperativeUndergo IORT | Radiation | Treatment (IORT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (IORT) |
Primary outcome
Incidence of local recurrence
Time frame: Up to 5 years
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.
Frequency of site of relapse within the breast
Time frame: Up to 5 years
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).
Percentage of participants with treatment-related adverse events
Time frame: Up to 5 years
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
Median Relapse-free survival
Time frame: Up to 5 years
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
Median Overall Survival
Time frame: Up to 5 years
Overall survival will be the time interval between enrollment and death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Michael Alvarado, MD principal investigator
University of California, San Francisco
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Radiation Therapy and Laboratory Biomarker Analysis in people with Stage IA Breast Cancer and Stage IIA Breast Cancer, run by University of California, San Francisco at 25 sites 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 2 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of local recurrence (time frame: Up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.