Clinical trial · Interventional
Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study
- 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)
Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| interstitial high dose-rate brachytherapy, PBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single arm study
- description
- single arm study
- interventionNames
- Radiation: interstitial high dose-rate brachytherapy, PBI
Primary outcomes (2)
- measure
- cancer related deaths
- timeFrame
- 6 months
- measure
- local relapses
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- quality of life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> or = 40 years * ECOG performance status 0-2 * T dimensions ≤ 2.5 cm * Negative surgical margins * Negative axillary lymph nodes * Suitable breast anatomy for implantation Exclusion Criteria: * Age \< 40 years * ECOG performance status \> 2 * T dimensions \> 2.5 * Positive surgical margins * Positive axillary lymph node * Infiltrating lobular histology * Significant areas of lobular carcinoma in situ * Paget's disease of the nipple * Extensive intraductal component (EIC) * Lymphovascular invasion * Multifocality (n) skin infiltration
References
Publications (1)
- DERIVEDAristei C, Palumbo I, Capezzali G, Farneti A, Bini V, Falcinelli L, Margaritelli M, Lancellotta V, Zucchetti C, Perrucci E. Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy. Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14. PMID 24044802