NCT03612648

Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma

Evaluation of Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).

Conditions

• Breast Carcinoma
• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Three Fraction Accelerated Partial Breast Irradiation	* TRI-APBI simulation must take place no more than 8 weeks from final definitive breast surgery * Machines that could be used include: SAVI applicator, The ViewRay System for Radiation Therapy, The ViewRay (MRIdian) Linac System, Halcyon, True Beam, True Beam STx, Edge Radiotherapy Delivery System
PROCEDURE	Partial mastectomy	-Standard of Care

Timeline

• Start date: 2018-08-30
• Primary completion: 2026-04-28
• Completion: 2026-04-28
• First posted: 2018-08-02
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study