RecruitingNot ApplicableNCT04360330

SABER Study for Selected Early Stage Breast Cancer

Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer


Sponsor

University of Miami

Enrollment

18 participants

Start Date

Aug 5, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an intensive, shorter-course radiation treatment for older women with early-stage, hormone-receptor-positive breast cancer following surgery. The goal is to deliver effective treatment in fewer visits while closely monitoring cancer control and side effects. **You may be eligible if:** - You are a woman aged 50 or older - You have confirmed invasive breast cancer that is ER/PR-positive and HER2-negative (hormone-driven, not HER2-driven) - Your cancer is small (stage T1N0M0 — no lymph node involvement, no spread) - Your cancer is in one spot only (unifocal) - You have had genomic testing (Oncotype DX or MammaPrint) before starting treatment - You are in good general health and able to have MRI scans **You may NOT be eligible if:** - You have cancer in more than one location in the breast - Your cancer has spread to lymph nodes or other organs - You are HER2-positive or hormone-receptor-negative - You are under 50 years of age Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Ablative Breast Radiotherapy

Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy) * Dose Level III: 45 Gy (5 fractions of 9 Gy) * Dose Level IV: 50 Gy (5 fractions of 10 Gy)


Locations(1)

University of Miami

Miami, Florida, United States

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NCT04360330


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