Clinical trial · Interventional
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial
NCT05498311CI-TRIAL-00060318IORT_BREASTunknownPhase 2ClinicalTrials.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)
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast conservative surgery | Procedure | — | UNRESOLVED |
| External Beam Hypofractionated Radiotherapy (EBRT) | Radiation | — | UNRESOLVED |
| Intraoperative Radiotherapy (IORT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Radiotherapy (IORT)
- description
- Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.
- interventionNames
- Radiation: Intraoperative Radiotherapy (IORT)
- Procedure: Breast conservative surgery
- Radiation: External Beam Hypofractionated Radiotherapy (EBRT)
Primary outcomes (2)
- measure
- Changes in Cosmetic results - BCCT
- timeFrame
- Baseline and every 12 months until 60 months
- description
- It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy. * Not pregnant at diagnosis. * Signed informed consent form. * Age ≥45 years old. * Patients candidates to Intrabeam. * Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery: * Tumor size \> 2.5 cm. * Extensive intraductal carcinoma (≥25%) * Lymphovascular invasion. * Involved focal margins (\<2mm) without ampliation surgery. Exclusion Criteria: * Presence of distant metastasis. * Primary chemotherapy. * Lymph node involvement. * Negative hormonal receptors. * Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas * Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis). * Uncontrolled infection. * Concurrent treatment with other experimental treatments * Lack of signed informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.