RecruitingNot Applicable

SABER Study for Selected Early Stage Breast Cancer

United States18 participantsStarted 2020-08-05

Plain-language 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.

Who can participate

Age range

50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female, ≥ 50 years of age.
. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
. Histologically confirmed invasive breast cancer.
. Clinical stage T1N0M0.
. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
. Unifocal breast cancer.
. Eastern Cooperative Oncology Group (ECOG) 0, 1.
. Ability to undergo MRI.

Exclusion criteria

. Patients without histologically confirmed invasive breast cancer.
. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
. Patients with metastatic disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER

Timeframe: Up to 13 Weeks

Trial details

NCT IDNCT04360330

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Zuzel Rodriguez

305-243-0124 z.rodriguez1@med.miami.edu

View on ClinicalTrials.gov More Breast Cancer trials