Clinical trial · Interventional
PBI for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment
Partial Radiotherapy for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment
- 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)
Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.
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 |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| external beams radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Partial Breast Irradiation
- description
- Radiation treatment will be started within 120 days after surgery. The fractionation schedule depends on the policy of the treating center, but is mandatory to use CT-based planning. Both once-daily and twice-daily schedule are allowed. The allowed schedules for external beams radiotherapy are: * 40 Gy in 15 fractions; * 30 Gy in 5 fractions; * 40 Gy or 38.5 in 10 twice-daily fractions (each daily dose must be separated by at least 6 hours). The schedule for brachytherapy are: * 32 Gy in 8 twice-daily fractions for HDR; * 30.3 Gy in 7 twice-daily fractions for HDR; * 50Gy 0.60-0.80 Gy/hour (1 pulse/hour, 24 hours/day) for PDR.
- interventionNames
- Radiation: external beams radiotherapy
- Radiation: brachytherapy
Primary outcomes (1)
- measure
- Local Control rate
- timeFrame
- 5 years
- description
- Absence of the occurrence of new lump in the irradiated breast or appearance of skin lesions; it will be divided in inside or outside the treated area, evaluating the localization in the breast. For the evaluation it will be used bilateral mammography.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 41 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>40 * Pathologically confirmed DCIS: 1. low risk (lesions of ≤3 cm diameter, resection margins of at least 2 mm, nuclei grade: G1, G2) 2. intermediate risk (lesions of ≤1 cm diameter, resection margins of at least 2 mm, nuclei grade: 3) * Written informed consent Exclusion Criteria: * Prior thoracic radiation therapy * Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy); * Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae * No other cancers in the last 5 years
References
Publications (0)
Data not yet available