RecruitingNCT04985032

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial


Sponsor

RPCR, Inc.

Enrollment

200 participants

Start Date

Aug 15, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years


Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing accelerated partial breast irradiation (APBI) — a shorter, more targeted form of radiation that focuses only on the area around the lumpectomy site rather than the whole breast — using a technique called stereotactic body radiation therapy (SBRT) in women with early-stage breast cancer. **You may be eligible if...** - You are a woman aged 50 or older - You have early-stage breast cancer (low-to-intermediate grade DCIS or invasive ductal carcinoma) - Your tumor is less than 2 cm (or less than 2.5 cm for DCIS) - You have had a lumpectomy with clear margins and no lymph node involvement - Your cancer is hormone receptor-positive, HER2-negative, and BRCA-negative **You may NOT be eligible if...** - You have lobular breast cancer or cancer in multiple spots - Your cancer has spread to lymph nodes or distant organs - You received chemotherapy before surgery (neoadjuvant) - You have an ipsilateral (same-side) pacemaker or breast implant - You are pregnant or have severe heart, lung, or liver disease 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 body radiation therapy

Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less


Locations(2)

CyberKnife Center of South Florida in Stuart

Stuart, Florida, United States

CyberKnife Centers of Tampa Bay

Tampa, Florida, United States

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NCT04985032


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