Clinical trial · Interventional
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
- 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)
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.
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 After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionation with simultaneous integrated boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionation with SIB
- interventionNames
- Radiation: Hypofractionation with simultaneous integrated boost
Primary outcomes (1)
- measure
- Acute Skin Toxicity
- timeFrame
- 6 months
- description
- Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Secondary outcomes (4)
- measure
- Number of Patients treated on Protocol
- timeFrame
- 22-29 days (16 fractions)
- description
- Dose constraints Dmedian lung \< 10 Gy; Dmedian heart \< 5 Gy, Dmax ≤ 40 Gy; Dmedian anterior branch of the left coronary artery (LAD, RIVA) \< 15 Gy, Dmax ≤ 40 Gy; Dmedian contralateral breast \< 3 Gy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins * Indication to adjuvant radiotherapy including boost radiotherapy * Clearly identified primary tumor region preferably by radiopaque clips * Primary wound healing after breast conserving therapy without signs of infection * Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated * Written informed consent Exclusion Criteria: * Patients operated by mastectomy * No indication for boost radiation * Resection margins positive for disease or insufficient identification of the boost volume * Indication for radiotherapy of the regional lymph nodes * History of prior breast or thoracic radiotherapy * Extended postoperative seroma at the beginning of radiotherapy * Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance * Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
References
Publications (0)
Data not yet available