Clinical trial · Observational
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
NCT04985032CI-TRIAL-00060132recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Ductal Carcinoma of Female Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)
- timeFrame
- 2-3 years
- description
- physician and patient assessment of breast cosmetic result following SBRT
- measure
- Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
- 1-6 weeks
- description
- assessment of skin and breast tissue changes during and immediately following SBRT
- measure
- Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
- 3-60 months
- description
- assessment of pulmonary, cardiac and chest wall changes following SBRT
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDNational Comprehensive Cancer Network. Invasive Breast Cancer (Version 1.2021) https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
- BACKGROUND2Bonfantini F, De Martin E, Giandini T, Fumagalli ML, Cavallo A, Pinzi V, et al. A Dosimetric Comparison between Three Different External Photon Beam Techniques for Accelerated Partial Breast Irradiation. Clin Oncol. 2018; 3:1501.
- BACKGROUNDHepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22. PMID 19395195
- BACKGROUNDWolmark N, Curran WJ, Vicini F, White J, Costantino JP, Arthur D, Kuske R, Rabinovitch R, Julian TB, Parda DS. Response to "Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation" (Int J Radiat Oncol Biol Phys 2010;76:71-78) and "Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation" Int J Radiat Oncol Biol Phys 2009;75:1290-1296). Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):317; author reply 318. doi: 10.1016/j.ijrobp.2009.12.033. No abstract available. PMID 20394863
- BACKGROUNDWhelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5. PMID 31813635
- BACKGROUNDVicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.