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Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial

Who can join

Ages 50 to 100 · Women · Healthy volunteers welcome

Inclusion Criteria:

1. Women 50 years or older
2. Low to intermediate grade DCIS or invasive ductal carcinoma
3. Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS
4. Well defined lumpectomy cavity on CT
5. Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS
6. Node negative
7. Unifocal lesion
8. ER and/or PR positive
9. HER-2 negative
10. BRCA negative
11. Lumpectomy cavity must be \< 30% of whole breast volume

Exclusion Criteria:

1. Lobular histology
2. Angiolymphatic invasion
3. Multiple foci of disease
4. Lymphovascular invasion
5. Active lupus or sarcoid
6. Distant metastases
7. Non-epithelial malignancies
8. Synchronous contralateral breast cancer
9. Grade 2 or higher oncoplastic surgery
10. Ipsilateral pacemaker
11. Ipsilateral breast implant
12. Neoadjuvant chemotherapy
13. Prior ipsilateral breast cancer or thoracic radiation
14. Poor breast integrity
15. Paget's Disease of the nipple
16. Pregnant patients
17. Severe cardiac, pulmonary, or liver diseases

About the study

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

What is being tested

• stereotactic body radiation therapy (radiation)

Sponsor: RPCR, Inc. · Participants: 200 · Started: Aug 15, 2022

Contact the study team

• Mark Perman, MD · Phone: 772-293-0377
• Debra Freeman, MD · Phone: 239-262-5168

Official record on ClinicalTrials.gov — NCT04985032

Locations in the U.S.

Conditions

• Ductal Carcinoma In Situ (DCIS)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.