Status:
RECRUITING
SABER Study for Selected Early Stage Breast Cancer
Lead Sponsor:
University of Miami
Conditions:
Breast Cancer
Early-stage Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04360330
Start Date
August 5 2020
End Date
May 1 2028
Last Update
June 8 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136