Accelerated Partial Breast Irradiation using Stereotactic Body Radiation Therapy
Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial
This study is testing a new type of targeted radiation treatment for women with certain types of breast cancer to see if it is safe and effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | Female |
| Sponsor | RPCR, Inc. Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Stuart, Florida and 1 other locations) |
| Trial ID | NCT04985032 on ClinicalTrials.gov |
What this trial studies
This observational registry investigates the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using Stereotactic Body Radiation Therapy (SBRT) in women with ductal carcinoma in situ or invasive ductal carcinoma. The study aims to enroll 200 patients who will receive a total dose of 30 Gy over 5 treatment sessions, utilizing advanced imaging techniques for precise targeting. Participants will be followed for 5 years to assess outcomes and safety.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with low to intermediate grade ductal carcinoma in situ or invasive ductal carcinoma meeting specific tumor size and surgical margin criteria.
Not a fit: Patients with lobular histology, multiple disease foci, or those with prior breast cancer treatments are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less invasive treatment option for early-stage breast cancer patients.
How similar studies have performed: Other studies utilizing stereotactic body radiation therapy for breast cancer have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women 50 years or older 2. Low to intermediate grade DCIS or invasive ductal carcinoma 3. Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS 4. Well defined lumpectomy cavity on CT 5. Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS 6. Node negative 7. Unifocal lesion 8. ER and/or PR positive 9. HER-2 negative 10. BRCA negative 11. Lumpectomy cavity must be \< 30% of whole breast volume Exclusion Criteria: 1. Lobular histology 2. Angiolymphatic invasion 3. Multiple foci of disease 4. Lymphovascular invasion 5. Active lupus or sarcoid 6. Distant metastases 7. Non-epithelial malignancies 8. Synchronous contralateral breast cancer 9. Grade 2 or higher oncoplastic surgery 10. Ipsilateral pacemaker 11. Ipsilateral breast implant 12. Neoadjuvant chemotherapy 13. Prior ipsilateral breast cancer or thoracic radiation 14. Poor breast integrity 15. Paget's Disease of the nipple 16. Pregnant patients 17. Severe cardiac, pulmonary, or liver diseases
Where this trial is running
Stuart, Florida and 1 other locations
- CyberKnife Center of South Florida in Stuart — Stuart, Florida, United States (Recruiting)
- CyberKnife Centers of Tampa Bay — Tampa, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Mark Perman, MD
- Email: Mark.Perman@usa.genesiscare.com
- Phone: 772-293-0377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.