Lumpectomy for Breast Cancer

Phase 2

Recruiting

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

Timeline

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

Select...

Your doctor may recommend an ultrasound and biopsy of lymph nodes in your armpit area if there are any concerns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumpectomy

2008

N/A

~670

Radiation Therapy

2017

Completed Phase 3

~7250