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SABER Study for Selected Early Stage Breast Cancer

NCT04360330 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-08

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Cristiane Takita, MD, MBA · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2026-05-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360330 on ClinicalTrials.gov