NCT04360330

SABER Study for Selected Early Stage Breast Cancer

Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.

Conditions

• Breast Cancer
• Early-stage Breast Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Ablative Breast Radiotherapy	Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy) * Dose Level III: 45 Gy (5 fractions of 9 Gy) * Dose Level IV: 50 Gy (5 fractions of 10 Gy)

Timeline

• Start date: 2020-08-05
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2020-04-24
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study