NCT04360330 SABER Study for Selected Early Stage Breast Cancer
| NCT ID | NCT04360330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2020-08-05 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2020-08-05 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Cristiane Takita, MD, MBA
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT04360330 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04360330 currently recruiting?
Yes, NCT04360330 is actively recruiting participants. Contact the research team at z.rodriguez1@med.miami.edu for enrollment information.
Where is the NCT04360330 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT04360330 clinical trial?
NCT04360330 is sponsored by University of Miami. The principal investigator is Cristiane Takita, MD, MBA at University of Miami. The trial plans to enroll 18 participants.
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