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

Recruiting now

Conditions studied: Ductal Carcinoma in Situ, Invasive Ductal Carcinoma of Female Breast

In brief

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

Key facts

Study ID

NCT04985032

Run by

RPCR, Inc.

People needed

200

Starts

2022-08-15

Expected to finish

2027-06-01

Last updated by the study team

2022-08-05

Who can join

Age: 50 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women 50 years or older
• Low to intermediate grade DCIS or invasive ductal carcinoma
• Tumor size < 2 cm invasive ductal carcinoma and < 2.5 cm DCIS
• Well defined lumpectomy cavity on CT
• Clear surgical ink margins > 2mm for invasive cancer and > 3 mm for DCIS
• Node negative
• Unifocal lesion
• ER and/or PR positive
• HER-2 negative
• BRCA negative
• Lumpectomy cavity must be < 30% of whole breast volume

You may not qualify if…

• Lobular histology
• Angiolymphatic invasion
• Multiple foci of disease
• Lymphovascular invasion
• Active lupus or sarcoid
• Distant metastases
• Non-epithelial malignancies
• Synchronous contralateral breast cancer
• Grade 2 or higher oncoplastic surgery
• Ipsilateral pacemaker
• Ipsilateral breast implant
• Neoadjuvant chemotherapy
• Prior ipsilateral breast cancer or thoracic radiation
• Poor breast integrity
• Paget's Disease of the nipple
• Pregnant patients
• Severe cardiac, pulmonary, or liver diseases

Where it is running

• CyberKnife Center of South Florida in Stuart — Stuart, Florida, United States (enrolling)
• CyberKnife Centers of Tampa Bay — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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