Lumpectomy for Breast Cancer

Phase 2
Led By Jose Bazan, MD, MS
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
Be older than 18 years old
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upat 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial looks at the side effects of giving a single dose of electron beam radiation to the tumor cavity during breast surgery before reconstruction.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your doctor may recommend an ultrasound and biopsy of lymph nodes in your armpit area if there are any concerns.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
Secondary outcome measures
Change in self-reported cosmesis using the BCTOS
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
Quality of life assessed by Breast Cancer Treatment Outcome Scale
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IOERT boost)Experimental Treatment6 Interventions
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
Completed Phase 3
Reconstructive Surgery

Find a site

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
302 Previous Clinical Trials
288,681 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
Jose Bazan, MD, MSPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
1 Previous Clinical Trials
61 Total Patients Enrolled

Media Library

Lumpectomy Clinical Trial Eligibility Overview. Trial Name: NCT02927912 — Phase 2
Breast Cancer Research Study Groups: Treatment (IOERT boost)
Breast Cancer Clinical Trial 2023: Lumpectomy Highlights & Side Effects. Trial Name: NCT02927912 — Phase 2
Lumpectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02927912 — Phase 2

Frequently Asked Questions

~5 spots leftby Dec 2023