Clinical trial · Interventional
Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer
Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
- 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. Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.
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 |
|---|---|---|---|
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionation with SIB | Radiation | — | UNRESOLVED |
| Standard Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard radiation
- description
- Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
- interventionNames
- Radiation: Standard Radiation
- type
- EXPERIMENTAL
- label
- Hypofractionation with SIB
- description
- Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
- interventionNames
- Radiation: Hypofractionation with SIB
Primary outcomes (1)
- measure
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 independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated) * 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 * Age ≥ 18 years * ECOG ≤ 2 Performance Status * Written informed consent * Compliance regarding treatment appointments and toxicity * Linguistic and cognitive ability to understand the questionnaires Exclusion Criteria: * Patients operated by mastectomy * No indication for boost radiation (e.g. status after IORT) * double sided breast cancer * 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 * Previously administered radiotherapy not allowing the required dose * Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception * treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment. * Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
References
Publications (1)
- BACKGROUNDKrug D, Vonthein R, Schreiber A, Boicev AD, Zimmer J, Laubach R, Weidner N, Dinges S, Hipp M, Schneider R, Weinstrauch E, Martin T, Horner-Rieber J, Olbrich D, Illen A, Hessler N, Konig IR, Dellas K, Dunst J. Impact of guideline changes on adoption of hypofractionation and breast cancer patient characteristics in the randomized controlled HYPOSIB trial. Strahlenther Onkol. 2021 Sep;197(9):802-811. doi: 10.1007/s00066-020-01730-9. Epub 2020 Dec 15. PMID 33320286