Trial Outcomes & Findings for Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction (NCT NCT02927912)

Last Updated: 2026-06-03

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

108 participants

Primary outcome timeframe

Up to 30 days after surgery and IOERT boost

Results posted on

2026-06-03

Participant Flow

Three participants enrolled in the study but were deemed not eligible before starting the study procedures.

Participant milestones

Participant milestones
Measure	Treatment (IOERT Boost) 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.
Overall Study STARTED	105
Overall Study Received IORT	102
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (IOERT Boost) 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.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Insurance	1

Baseline Characteristics

Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (IOERT Boost) n=105 Participants 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.
Age, Continuous	55 years n=20 Participants
Sex: Female, Male Female	105 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	9 Participants n=20 Participants
Race (NIH/OMB) White	89 Participants n=20 Participants
Race (NIH/OMB) More than one race	1 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=20 Participants
Region of Enrollment United States	105 Participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 30 days after surgery and IOERT boost

Population: Only the first 30 participants were analyzed for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (IOERT Boost) n=30 Participants 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.
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	0 Number of Events

PRIMARY outcome

Timeframe: At 1 year from the end of therapy

Population: Only participants who underwent IOERT are included for analysis

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.

Outcome measures

Outcome measures
Measure	Treatment (IOERT Boost) n=102 Participants 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.
Rate of Grade 3 Fibrosis Using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic Scales Grade 3 Fibrosis	2 Participants
Rate of Grade 3 Fibrosis Using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic Scales No Grade 3 Fibrosis	100 Participants

SECONDARY outcome

Timeframe: Baseline up to 3 years

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years after completion of radiation therapy

physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years after completion of radiation therapy

determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 5 years

The exact binomial confidence interval for the rate will be calculated.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (IOERT Boost)

Serious events: 36 serious events

Other events: 103 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (IOERT Boost) n=105 participants at risk 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.
Blood and lymphatic system disorders Leukocytosis (SAE)	0.95% 1/105 • Up to 5 years
Cardiac disorders Atrial fibrillation (SAE)	0.95% 1/105 • Up to 5 years
Vascular disorders Hematoma, left breast	0.95% 1/105 • Up to 5 years
Vascular disorders Hypertension	0.95% 1/105 • Up to 5 years
Cardiac disorders Aortic valve replacement, coronary artery bypass grafting, and maze ablation (SAE)	0.95% 1/105 • Up to 5 years
Gastrointestinal disorders Abdominal pain	0.95% 1/105 • Up to 5 years
Gastrointestinal disorders Diverticulitis	0.95% 1/105 • Up to 5 years
Gastrointestinal disorders Duodenal Hemorrhage	0.95% 1/105 • Up to 5 years
Gastrointestinal disorders Nausea	0.95% 1/105 • Up to 5 years
Gastrointestinal disorders Vomiting	0.95% 1/105 • Up to 5 years
General disorders and administration site conditions non-cardiac chest pain	0.95% 1/105 • Up to 5 years
Infections and infestations Appendicitis (SAE)	0.95% 1/105 • Up to 5 years
Infections and infestations Localized edema and erythema treated as cellulitis, bilateral lower extremities (SAE)	0.95% 1/105 • Up to 5 years
Infections and infestations Lung Infection, pneumonia	0.95% 1/105 • Up to 5 years
Infections and infestations Skin infection, right arm cellulitis, intermittent	0.95% 1/105 • Up to 5 years
Infections and infestations Urinary Tract Infection (SAE)	0.95% 1/105 • Up to 5 years
Injury, poisoning and procedural complications Ankle fracture	0.95% 1/105 • Up to 5 years
Injury, poisoning and procedural complications Dermatitis Radiation	0.95% 1/105 • Up to 5 years
Injury, poisoning and procedural complications Fracture, closed fracture tibia and fibula	0.95% 1/105 • Up to 5 years
Injury, poisoning and procedural complications Fracture-nondisplaced sternal fracture	0.95% 1/105 • Up to 5 years
Injury, poisoning and procedural complications Hip Fracture	0.95% 1/105 • Up to 5 years
Metabolism and nutrition disorders Dehydration	0.95% 1/105 • Up to 5 years
Metabolism and nutrition disorders Hypokalemia	0.95% 1/105 • Up to 5 years
Metabolism and nutrition disorders Hyponatremia (SAE)	0.95% 1/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Arthralgia	0.95% 1/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, left knee bursitis (SAE)	0.95% 1/105 • Up to 5 years
Nervous system disorders Headache (SAE)	0.95% 1/105 • Up to 5 years
Nervous system disorders Syncope (SAE)	0.95% 1/105 • Up to 5 years
Reproductive system and breast disorders Reproductive system and breast disorders - other, menstrual cramps	0.95% 1/105 • Up to 5 years
Reproductive system and breast disorders Hysterectomy/BSO due to heavy menstrual bleeding and dysmenorrhea (SAE)	0.95% 1/105 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Epistaxis, intermittent	0.95% 1/105 • Up to 5 years
Skin and subcutaneous tissue disorders Breast Retraction	0.95% 1/105 • Up to 5 years
Skin and subcutaneous tissue disorders Dry skin, whole body	0.95% 1/105 • Up to 5 years
Skin and subcutaneous tissue disorders Paronychia on finger	0.95% 1/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin hypopigmentation, left breast	0.95% 1/105 • Up to 5 years
Surgical and medical procedures Surgical and medical procedure, intracranial hypertension	0.95% 1/105 • Up to 5 years
Surgical and medical procedures Surgical and medical procedures - Other, Hysterectomy, BSO (elective surgery)	0.95% 1/105 • Up to 5 years
Surgical and medical procedures Surgical and medical procedures, Right shoulder reverse total shoulder arthroplasty (SAE)	0.95% 1/105 • Up to 5 years
Vascular disorders Arterial thromboembolism	0.95% 1/105 • Up to 5 years
Vascular disorders Hematoma	1.9% 2/105 • Up to 5 years

Other adverse events

Other adverse events
Measure	Treatment (IOERT Boost) n=105 participants at risk 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.
Vascular disorders hot flashes	5.7% 6/105 • Up to 5 years
Metabolism and nutrition disorders Anorexia	5.7% 6/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Arthralgia	30.5% 32/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Back pain	7.6% 8/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Fibrosis	12.4% 13/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	6.7% 7/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue, left breast	18.1% 19/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue, right breast	18.1% 19/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Joint range of motion decreased, right shoulder	5.7% 6/105 • Up to 5 years
Musculoskeletal and connective tissue disorders Myalgia	6.7% 7/105 • Up to 5 years
Nervous system disorders Dizziness	10.5% 11/105 • Up to 5 years
Nervous system disorders Headache	13.3% 14/105 • Up to 5 years
Psychiatric disorders Anxiety	7.6% 8/105 • Up to 5 years
Psychiatric disorders Depression	7.6% 8/105 • Up to 5 years
Psychiatric disorders Insomnia	5.7% 6/105 • Up to 5 years
Reproductive system and breast disorders Breast Pain	7.6% 8/105 • Up to 5 years
Reproductive system and breast disorders Breast atrophy	5.7% 6/105 • Up to 5 years
Reproductive system and breast disorders Breast atrophy, left breast	7.6% 8/105 • Up to 5 years
Reproductive system and breast disorders Breast atrophy, right	7.6% 8/105 • Up to 5 years
Reproductive system and breast disorders Breast atrophy, right breast	6.7% 7/105 • Up to 5 years
Reproductive system and breast disorders Breast pain, bilateral	8.6% 9/105 • Up to 5 years
Reproductive system and breast disorders Breast pain, left	8.6% 9/105 • Up to 5 years
Reproductive system and breast disorders Breast pain, left breast	5.7% 6/105 • Up to 5 years
Reproductive system and breast disorders Breast pain, right breast	13.3% 14/105 • Up to 5 years
Reproductive system and breast disorders Dyspareunia	5.7% 6/105 • Up to 5 years
Reproductive system and breast disorders Vaginal dryness	12.4% 13/105 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	10.5% 11/105 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	15.2% 16/105 • Up to 5 years
Skin and subcutaneous tissue disorders Alopecia	14.3% 15/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	10.5% 11/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	15.2% 16/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation, left breast	15.2% 16/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation, right breast	15.2% 16/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin hypopigmentation, left breast	5.7% 6/105 • Up to 5 years
Skin and subcutaneous tissue disorders Skin induration, left breast	5.7% 6/105 • Up to 5 years
Vascular disorders Hot Flashes	13.3% 14/105 • Up to 5 years
Vascular disorders Hot flashes	26.7% 28/105 • Up to 5 years
Vascular disorders Hypertension	13.3% 14/105 • Up to 5 years
Gastrointestinal disorders Constipation	13.3% 14/105 • Up to 5 years
Gastrointestinal disorders Diarrhea	10.5% 11/105 • Up to 5 years
Gastrointestinal disorders Nausea	22.9% 24/105 • Up to 5 years
Gastrointestinal disorders Vomiting	6.7% 7/105 • Up to 5 years
General disorders and administration site conditions Fatigue	61.9% 65/105 • Up to 5 years
General disorders and administration site conditions Localized edema, bilateral breasts	7.6% 8/105 • Up to 5 years
General disorders and administration site conditions Localized edema, left breast	6.7% 7/105 • Up to 5 years
General disorders and administration site conditions Localized edema, right breast	6.7% 7/105 • Up to 5 years
General disorders and administration site conditions fatigue	7.6% 8/105 • Up to 5 years
Infections and infestations Upper respiratory infection, COVID-19	7.6% 8/105 • Up to 5 years
Infections and infestations Urinary tract infection	6.7% 7/105 • Up to 5 years
Injury, poisoning and procedural complications Dermatitis Radiation	19.0% 20/105 • Up to 5 years
Injury, poisoning and procedural complications Dermatitis radiation	16.2% 17/105 • Up to 5 years
Injury, poisoning and procedural complications Dermatitis radiation, left breast	12.4% 13/105 • Up to 5 years
Injury, poisoning and procedural complications Dermatitis radiation, right breast	9.5% 10/105 • Up to 5 years
Injury, poisoning and procedural complications Erythema	5.7% 6/105 • Up to 5 years
Injury, poisoning and procedural complications Fall	8.6% 9/105 • Up to 5 years
Investigations Weight gain	14.3% 15/105 • Up to 5 years
Investigations Weight loss	20.0% 21/105 • Up to 5 years

Additional Information

Dr. Sachin Jhawar

The Ohio State University Comprehensive Cancer Center

Phone: (614) 688-7040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place