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Radiation Therapy
Stereotactic Ablative Radiotherapy for Early Stage Breast Cancer (SABER Trial)
N/A
Recruiting
Led By Cristiane Takita, MD, MBA
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage T1N0M0
Unifocal breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Awards & highlights
SABER Trial Summary
This trial is testing a new, shorter radiation therapy regimen for breast cancer patients.
Who is the study for?
This trial is for women over 50 with early-stage breast cancer (T1N0M0), not spread elsewhere, confirmed by biopsy. They must have specific receptor statuses (ER/PR positive, HER2 negative) and be able to undergo MRI scans. Participants need an Oncotype or MammaPrint diagnosis before starting treatment and agree to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests different doses of Stereotactic Ablative Breast Radiotherapy given in a short time before standard surgery for breast tumors. The goal is to find the most effective radiation dose that can be administered quickly.See study design
What are the potential side effects?
Potential side effects may include skin changes, fatigue, pain or discomfort at the treatment site, swelling or fluid build-up, and rare risks associated with radiation like secondary cancers.
SABER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is early stage and has not spread.
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I have cancer in one area of my breast.
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My breast cancer diagnosis was confirmed through a biopsy.
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My cancer is ER/PR positive and HER2 negative.
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I am a woman aged 50 or older.
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I am fully active or have some restrictions but can still care for myself.
SABER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
Secondary outcome measures
Cosmesis Evaluation
Number of Participants Experiencing Treatment-Related Toxicity
Participant-Reported Health-Related Quality of Life (HR-QoL)
+1 moreSABER Trial Design
1Treatment groups
Experimental Treatment
Group I: Preoperative SABERExperimental Treatment1 Intervention
Experimental: Preoperative Stereotactic Ablative Breast Radiotherapy (SABER). Phase I study testing up to 4 dose levels.
Non-experimental: Participants will undergo standard partial mastectomy and axillary surgery as per discretion of treating physician 4 to 6 weeks (+ at most 1 week delay) after preoperative SABER is completed.
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Who is running the clinical trial?
University of MiamiLead Sponsor
901 Previous Clinical Trials
409,968 Total Patients Enrolled
16 Trials studying Breast Cancer
1,533 Patients Enrolled for Breast Cancer
Cristiane Takita, MD, MBAPrincipal Investigator - University of Miami
Anne Bates Leach Eye Hospital Bascom Palmer Eye Institute, Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami
University De Sao Paulo (Medical School)
Washington U/B-Jh/Slch Conc (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation treatment to my chest before.My cancer has spread to other parts of my body.You do not have the results of Oncotype or MammaPrint testing when treatment begins.My breast cancer has not been confirmed by tissue analysis.I have a history of diseases like lupus, scleroderma, or dermatomyositis.My cancer is early stage and has not spread.I have cancer in one area of my breast.My breast cancer diagnosis was confirmed through a biopsy.You need to have a specific test result before starting the treatment.I have not been diagnosed with any cancer other than non-melanoma skin cancer in the last 5 years.I have limited ability to care for myself.You cannot have an MRI scan.My cancer is ER/PR positive and HER2 negative.I am a woman aged 50 or older.I am fully active or have some restrictions but can still care for myself.You can have an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Preoperative SABER
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients have enrolled in this investigation?
"In the affirmative, clinicaltrials.gov has evidence that this study is currently recruiting patients. This venture was started on August 5th 2020 and last amended on January 7th 2022. A total of 18 people are needed to participate at a single facility."
Answered by AI
Is there any availability for participants to join this research endeavor?
"Per the information posted on clinicaltrials.gov, recruitment for this trial remains active as of January 7th 2022. Initially announced on August 5th 2020, the study is seeking participants."
Answered by AI
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