Clinical trial · Interventional
External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients
A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery
NCT06224244CI-TRIAL-00092632ESIBIREactive not recruitingPhase 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)
This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer
Conditions
Conditions (2)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost | Radiation | — | UNRESOLVED |
| Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Simultaneous integrated boost to 40 Gy (SIB 40)
- description
- Patients with the following clinico-pathological characteristics * pTis G3, * pT1 pN0/pN1mic, G1-G3 luminal biology or Her-2 positive
- interventionNames
- Radiation: Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost
- type
- ACTIVE_COMPARATOR
- label
- Simultaneous integrated boost to 43 Gy (SIB 43)
- description
- Patients with the following clinico-pathological characteristics: * Triple negative disease, * pT2 pN0/pN1mic, * ≤ 50 years not Luminal A
- interventionNames
- Radiation: Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven invasive or in situ unifocal adenocarcinoma of the breast * Breast conserving surgery * Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \[i+\] allowed) pN1mic, M0 stage * Postoperative negative (no ink) final surgical margins * Patient requires a whole breast radiotherapy plus a tumor bed boost * Female patients aged ≥ 18 years of any menopausal status * ECOG performance status 0-2 Exclusion Criteria: * Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free * Mastectomy * Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded) * Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma * Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder * Pregnant or lactating patients * Presence of ipsilateral breast implant * Prior breast or thoracic radiotherapy for any condition
References
Publications (3)
- RESULTColes CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC, Bhattacharya I, Brunt AM, Chan HYC, Donovan EM, Eaton DJ, Emson M, Hopwood P, Jefford ML, Lightowlers SV, Sawyer EJ, Syndikus I, Tsang YM, Twyman NI, Yarnold JR, Bliss JM; IMPORT Trial Management Group. Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. Lancet. 2023 Jun 24;401(10394):2124-2137. doi: 10.1016/S0140-6736(23)00619-0. Epub 2023 Jun 8. PMID 37302395
- RESULTPinnaro P, Giordano C, Farneti A, Faiella A, Iaccarino G, Landoni V, Giannarelli D, Vici P, Strigari L, Sanguineti G. Short course hypofractionated whole breast irradiation after conservative surgery: a single institution phase II study. J Exp Clin Cancer Res. 2017 Dec 27;36(1):191. doi: 10.1186/s13046-017-0640-z. PMID 29282078
- RESULTPinnaro P, Soriani A, Landoni V, Giordano C, Papale M, Marsella A, Marucci L, Arcangeli G, Strigari L. Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. J Exp Clin Cancer Res. 2010 Jan 25;29(1):9. doi: 10.1186/1756-9966-29-9. PMID 20100335