SABER Study for Selected Early Stage Breast Cancer

NARecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 5, 2020

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2028

Conditions
Breast CancerEarly-stage Breast Cancer
Interventions
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)"

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

All Listed Sponsors
lead

University of Miami

OTHER