Clinical trial · Interventional
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT
NCT01463007CI-TRIAL-00051889completedN/AResults postedClinicalTrials.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)
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated partial breast irradiation | Radiation | — | UNRESOLVED |
| Extended Follow up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiation
- description
- AccuBoost APBI- 34.0 Gy in 10fx
- interventionNames
- Radiation: Accelerated partial breast irradiation
- type
- EXPERIMENTAL
- label
- Extended Follow up
- description
- This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.
- interventionNames
- Other: Extended Follow up
Primary outcomes (1)
- measure
- Early and Intermediate Toxicity
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS 2. Age greater or equal to 50 years old 3. Life expectancy \> 6 months 4. Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy 5. Pathologic tumor size less than or equal to 2 cm 6. Invasive ductal, mucinous, tubular or colloid histology 7. Estrogen receptor positive for invasive carcinoma. 8. Unifocal/unicentric disease 9. Negative surgical margins greater than or equal to 2 mm 10. Pathologic lymph node negative 11. No evidence of lymphovascular invasion 12. ECOG performance status of 0 or 1 (Appendix 1) 13. Informed consent signed. Exclusion Criteria: 1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required) 2. Autoimmune disorder 3. Pregnancy 4. Breast implants 5. Psychiatric or addictive disorder that would preclude attending follow-up 6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted) 7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign) 8. Lobular features on histology (pure or mixed) or sarcoma histology 9. Node positive on axillary dissection or in the sentinel lymph node biopsy; 10. Extensive in situ carcinoma (EIC) 11. Multicentric or multifocal disease 12. Paget's disease of the nipple 13. Distant metastases 14. Lumpectomy cavity not well visualized on AccuBoost imaging 15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV \> 6cm) 16. Breast separation with compression \> 7cm. 17. Overlap of skin between orthogonal treatment axes.
References
Publications (2)
- DERIVEDHepel JT, Leonard KL, Sha S, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. Phase 2 Trial of Accelerated Partial Breast Irradiation (APBI) Using Noninvasive Image Guided Breast Brachytherapy (NIBB). Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1143-1149. doi: 10.1016/j.ijrobp.2020.07.2312. Epub 2020 Jul 25. PMID 32721422
- DERIVEDHepel JT, Hiatt JR, Sha S, Leonard KL, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. The rationale, technique, and feasibility of partial breast irradiation using noninvasive image-guided breast brachytherapy. Brachytherapy. 2014 Sep-Oct;13(5):493-501. doi: 10.1016/j.brachy.2014.05.014. Epub 2014 Jul 3. PMID 24997723