Stage IA Breast CancerPhase 2NCT02927912
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
A Phase 2 study testing Electron Beam Therapy, Lumpectomy and Quality-of-Life Assessment in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 5 sites in 2 countries.
Trial summary
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- What is being tested?
- Electron Beam Therapy, Lumpectomy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Oct 2017to 30 Nov 2026
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven diagnosis of breast cancer
- Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
- Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
- Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
- History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
- Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
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- Absolute neutrophil count > 1800 cells/cubic mm
- Platelets >= 75,000 cells/cubic mm
- Hemoglobin >= 8 g/dL
- Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patients must provide study specific informed consent prior to study entry
Who cannot join
- Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
- Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
- Two or more cancers not resectable through a single lumpectomy incision
- Bilateral breast cancer
- Ductal breast carcinoma in situ (DCIS) only
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- Non-epithelial breast malignancies such as sarcoma/lymphoma
- Male breast cancer
- Paget's disease of the nipple
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University Hospitals
Cleveland, Ohio, 44106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Canada1 site
Centre Hospitalier de I'Universite de Montreal
Québec, Montreal, H2X0C1
About this study
Official title: Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.
SECONDARY OBJECTIVES:
- To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.
III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.
OUTLINE:
Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 years.
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- Electron Beam Therapy, Lumpectomy, Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electron Beam TherapyRadiation
Also called photon beam radiation therapy
Undergo IOERT boost
LumpectomyProcedure or surgery
Also called Lumpectomy of Breast, Partial Mastectomy
Undergo lumpectomy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo whole breast radiation therapy
Reconstructive SurgeryProcedure or surgery
Also called Reconstruction
Undergo oncoplastic reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Treatment (IOERT boost) | Experimental | Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy. Receives: Radiation: Electron Beam Therapy; Procedure: Lumpectomy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Reconstructive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose-limiting Adverse Events in the First 30 Patients Enrolled as Graded by the National Cancer Institute Common Toxicity Criteria Version 4.0
If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
Measured: Up to 30 days after surgery and IOERT boost
Rate of Grade 3 Fibrosis Using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic Scales
The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.
Measured: At 1 year from the end of therapy
Secondary outcomes (4)
Change in Self-reported Cosmesis Using the BCTOS
The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time. The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.
Measured: Baseline up to 3 years
Physician Reported Cosmesis Using the Harvard Breast Cosmesis Scale and Digital Photographs
physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
Measured: Up to 3 years after completion of radiation therapy
Quality of Life Assessed by Breast Cancer Treatment Outcome Scale
determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
Measured: Up to 3 years after completion of radiation therapy
Rate of Ipsilateral Breast Tumor Recurrence
The exact binomial confidence interval for the rate will be calculated.
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study start16 Oct 2017
- Primary completion8 May 2025
- Study completion30 Nov 2026 (estimated)
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.
- Other trials for Stage IA Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sachin Jhawar, Ohio State University Comprehensive Cancer Center
- Investigators
- Jose Bazan, MD, MS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927912
- Sponsor's protocol ID
- OSU-16106
- Other IDs
- NCI-2016-01294
- Status last verified
- May 2026
- First submitted
- 6 Oct 2016
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02927912
- Acronym / sponsor ID
- OSU-16106
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
Detailed description
PRIMARY OBJECTIVES:
- To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.
SECONDARY OBJECTIVES:
- To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.
III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.
OUTLINE:
Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 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 (IOERT boost) | Experimental | Radiation: Electron Beam Therapy, Procedure: Lumpectomy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation Therapy, Procedure: Reconstructive SurgeryPatients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically proven diagnosis of breast cancer
- Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
- Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
- History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
- Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
Key exclusion criteria (13 listed)
- Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
- Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
- Two or more cancers not resectable through a single lumpectomy incision
- Bilateral 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 |
|---|---|---|
| Electron Beam TherapyAlso: photon beam radiation therapyUndergo IOERT boost | Radiation | Treatment (IOERT boost) |
| LumpectomyAlso: Lumpectomy of Breast, Partial MastectomyUndergo lumpectomy | Procedure or surgery | Treatment (IOERT boost) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (IOERT boost) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (IOERT boost) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo whole breast radiation therapy | Radiation | Treatment (IOERT boost) |
| Reconstructive SurgeryAlso: ReconstructionUndergo oncoplastic reconstruction | Procedure or surgery | Treatment (IOERT boost) |
Primary outcome
Number of Dose-limiting Adverse Events in the First 30 Patients Enrolled as Graded by the National Cancer Institute Common Toxicity Criteria Version 4.0
Time frame: Up to 30 days after surgery and IOERT boost
If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
Rate of Grade 3 Fibrosis Using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic Scales
Time frame: At 1 year from the end of therapy
The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.
4 secondary outcomes
Change in Self-reported Cosmesis Using the BCTOS
Time frame: Baseline up to 3 years
Physician Reported Cosmesis Using the Harvard Breast Cosmesis Scale and Digital Photographs
Time frame: Up to 3 years after completion of radiation therapy
Quality of Life Assessed by Breast Cancer Treatment Outcome Scale
Time frame: Up to 3 years after completion of radiation therapy
Rate of Ipsilateral Breast Tumor Recurrence
Time frame: At 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- 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.
Jose Bazan, MD, MS principal investigator
Ohio State University Comprehensive Cancer Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electron Beam Therapy, Lumpectomy and Quality-of-Life Assessment in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 5 sites in 2 countries.
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 12 inclusion and 13 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). 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?
Number of Dose-limiting Adverse Events in the First 30 Patients Enrolled as Graded by the National Cancer Institute Common Toxicity Criteria Version 4.0 (time frame: Up to 30 days after surgery and IOERT boost). The study lists 2 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 3 Jun 2026.