SABER Study for Early Stage Breast Cancer

This study is testing a new way to give radiation therapy called Stereotactic Ablative Breast Radiotherapy (SABER) to women with early-stage breast cancer. The goal is to find the best dose of SABER to give before surgery, in a shorter amount of time. Researchers will be looking for the recommended dose of SABER within 13 weeks. To join, you must be a woman at least 50 years old with early-stage breast cancer that is ER/PR positive and HER2 negative. Your Oncotype or MammaPrint results are also needed. The study is currently unclear on its recruitment status and plans to enroll 18 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 18 women.
What's involved
Participants will receive SABER radiation therapy in 5 sessions over 2 weeks, given on non-consecutive days. This will happen before standard partial mastectomy/axillary surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, finding the recommended dose, is measured up to 13 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04360330

SABER Study for Selected Early Stage Breast Cancer

Recruiting
NAAges 50+InterventionalTreatment
University of Miami
~18 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Stereotactic Ablative Breast Radiotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
Measured over Up to 13 Weeks
Breast Cancer
Early-stage Breast Cancer
1 sites across 1 states
Florida1
  • Cristiane Takita, MD, MBA · PRINCIPAL_INVESTIGATOR · University of Miami

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  • Recommended Phase 2 Dose (RP2D) of Pre-Operative SABERUp to 13 Weeks

    The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0