SABER Study for Selected Early Stage Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Early-stage Breast Cancer

In brief

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.

Key facts

Study ID

NCT04360330

Run by

University of Miami

People needed

18

Starts

2020-08-05

Expected to finish

2029-05-31

Last updated by the study team

2026-08-03

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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).

You may not qualify if…

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

Where it is running

• University of Miami — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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