Breast CancerNCT02370797
Node Negative, Invasive Breast Cancer Single Fraction IOERT
A study testing Single Fraction IOeRT in people with Breast Cancer, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Single Fraction IOeRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2029
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
- Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
- Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months.
- BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
- Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
- Grade 1, 2 acceptable
Show all 11Show fewer
- Associated LCIS is allowed
- Estrogen receptor (ER) status of positive
- Negative margins at ink on gross pathologic examination
- Patient is node-negative, defined as N0 (i-) or N0 (i+)
- Patient must be deemed functionally and mentally competent to understand and sign the informed consent
Who cannot join
- Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- Immuno-compromised status
- Pregnancy
- Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
- Breast cancer that involves the skin or chest wall, locally advanced breast cancer
- Pure DCIS, all grades
Show all 15Show fewer
- Invasive lobular carcinoma
- Evidence of lymphovascular invasion (LVI)
- Invasive carcinoma with extensive intraductal component (EIC)
- Neoadjuvant chemotherapy indicated
- Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
- Not eligible for breast conserving management, i.e., prior whole breast radiation therapy
- Estrogen receptor negative
- Her2 positive
- Grade 3
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
Read the detailed description
See points VIII inclusion/exclusion criteria
Operation:
- Lumpectomy, steninal node biopsy
- IOeRT
After Surgery:
- Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
- Chemotherapy (if indicated)
- Hormone therapy (if indicated)
Follow-Up
- Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.
- Assessements of acute toxicity according to CTC-toxicity scoring system
- Assessments of late toxicity according to LENT-SOMA scoring systems
- Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.
- Conditions
- Breast Cancer
- Being tested
- Single Fraction IOeRT
- Keywords
- IOERT, Radiation, Single fraction, Lumpectomy, Radiation therapy, Avera
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Fraction IOeRTRadiation
Also called Intra-Operative electron radiation therapy
A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Single Fraction IOeRT | Experimental | A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered. Receives: Radiation: Single Fraction IOeRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are free of breast cancer.
Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
Measured: 10 years
Secondary outcomes (1)
Local recurrance rate with acute toxicity and cosmetic evaluations
AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up.
Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Arneson, MD, Principal investigator, Avera Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370797
- Sponsor's protocol ID
- ACI-1450-IOERTSFX
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2015
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT02370797
- Acronym / sponsor ID
- ACI-1450-IOERTSFX
- Conditions
- Breast Cancer
- Keywords
- IOERT, Radiation, Single fraction, Lumpectomy, Radiation therapy, Avera
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 25 Feb 2015 (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.
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
Detailed description
See points VIII inclusion/exclusion criteria
Operation:
- Lumpectomy, steninal node biopsy
- IOeRT
After Surgery:
- Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
- Chemotherapy (if indicated)
- Hormone therapy (if indicated)
Follow-Up
- Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.
- Assessements of acute toxicity according to CTC-toxicity scoring system
- Assessments of late toxicity according to LENT-SOMA scoring systems
- Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Fraction IOeRT | Experimental | Radiation: Single Fraction IOeRTA single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
- Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
- Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months.
- BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
- Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
Key exclusion criteria (15 listed)
- Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- Immuno-compromised status
- Pregnancy
- Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
- Breast cancer that involves the skin or chest wall, locally advanced breast cancer
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 |
|---|---|---|
| Single Fraction IOeRTAlso: Intra-Operative electron radiation therapyA single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered. | Radiation | Single Fraction IOeRT |
Primary outcome
Proportion of patients who are free of breast cancer.
Time frame: 10 years
Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
1 secondary outcome
Local recurrance rate with acute toxicity and cosmetic evaluations
Time frame: 10 years
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 27 Oct 2026.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Kyle Arneson, MD principal investigator
Avera Cancer Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Fraction IOeRT in people with Breast Cancer, run by Avera McKennan Hospital & University Health Center 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 11 inclusion and 15 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 27 Oct 2026. 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?
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?
Proportion of patients who are free of breast cancer. (time frame: 10 years). 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 27 Oct 2026.