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Radiation Therapy

Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer

N/A
Waitlist Available
Led By Imran Zoberi, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after treatment
Awards & highlights

Study Summary

This trial is testing a new way to give partial breast radiation that uses less total radiation and could be done at many hospitals with common equipment.

Who is the study for?
This trial is for English-speaking postmenopausal women aged 50 or older with stage 0 or I breast cancer treated by partial mastectomy. They should have no prior non-hormonal therapy for the current cancer, no positive lymph nodes, and must be within 8 weeks of their last definitive breast procedure. Candidates cannot have certain other diseases, a history of other malignancies within the past 5 years (except some skin cancers), or extensive surgery that affects cosmetic outcomes.Check my eligibility
What is being tested?
The study tests Three Fraction Accelerated Partial Breast Irradiation (Tri-APBI) as the only radiation treatment after partial mastectomy in low-risk early-stage breast cancer patients. It aims to minimize adjuvant therapy impact using commonly available equipment at many oncology centers without specialized tools.See study design
What are the potential side effects?
While specific side effects are not listed here, Tri-APBI involves radiation which can cause skin changes, fatigue, discomfort at the treatment site, and potential impacts on nearby organs such as the heart and lungs depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is early stage, treated with partial mastectomy, and no spread to lymph nodes.
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My breast cancer is hormone receptor positive, HER2 negative, and my tumor is 2 cm or smaller.
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I haven't had hormone, chemo, or biologic therapy before TRI-APBI, but may have started hormone therapy after surgery.
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My breast surgery removed all the cancer with clear margins.
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I was diagnosed with my condition at age 50 or older.
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I am postmenopausal.
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I speak English.
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My radiation therapy will be done at BJH using specific equipment.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ipsilateral breast tumor recurrence rate
Acute Coryza
Tolerance of Tri-APBI as measured by the rate of late treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment
Secondary outcome measures
Change in Cosmesis as measured by the Aronson modified Harris scale
Change in Cosmesis as measured by the Breast Retraction Assessment
Change in Cosmesis as measured by the Percent Breast Retraction Assessment
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TRI-APBIExperimental Treatment2 Interventions
Brachytherapy TRI-APBI the PTV is prescribed 7.5 Gy x three fractions given over two to three days OR External beam TRI-APBI the PTV is prescribed 8.5 Gy x three fractions given over two to three days

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,011 Total Patients Enrolled
46 Trials studying Breast Cancer
5,091 Patients Enrolled for Breast Cancer
Imran Zoberi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
299 Total Patients Enrolled
1 Trials studying Breast Cancer
130 Patients Enrolled for Breast Cancer

Media Library

Three Fraction APBI (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03612648 — N/A
Breast Cancer Research Study Groups: TRI-APBI
Breast Cancer Clinical Trial 2023: Three Fraction APBI Highlights & Side Effects. Trial Name: NCT03612648 — N/A
Three Fraction APBI (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03612648 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial currently have open enrollment for participants?

"According to clinicaltrials.gov, this study is not presently recruiting new participants; the trial was first launched on August 30th 2018 and last updated on March 15th 2022. Although this particular trial has ended its recruitment period, there are 4862 other medical trials actively accepting patients at the moment."

Answered by AI
~20 spots leftby Mar 2026