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SABER Study for Selected Early Stage Breast Cancer

SABER Study for Selected Early Stage Breast Cancer

Recruiting
50 years and older
Female
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Female, ≥ 50 years of age.
  2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
  3. Histologically confirmed invasive breast cancer.
  4. Clinical stage T1N0M0.
  5. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
  6. Unifocal breast cancer.
  7. Eastern Cooperative Oncology Group (ECOG) 0, 1.
  8. Ability to undergo MRI.
  9. Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
  10. Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).

Exclusion Criteria:

  1. Patients without histologically confirmed invasive breast cancer.
  2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
  3. Patients with metastatic disease.
  4. ECOG 2, 3, 4.
  5. Patients that are unable to undergo MRI.
  6. Prior history of radiation to the chest.
  7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
  8. Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
  9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.
  10. Patients unable to consent, who are pregnant or nursing, or are prisoners.

Study details
    Breast Cancer
    Early-stage Breast Cancer

NCT04360330

University of Miami

15 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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