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NCT05586256
Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
trial testing ultra-hypofractionated whole breast irradiation in Female Breast Cancer in 300 participants. Currently enrolling.
21 July 2023
Quick facts
| Lead sponsor | University Of Perugia |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 21 July 2021 |
| Primary completion | 21 July 2023 |
| Estimated completion | 21 July 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- ultra-hypofractionated whole breast irradiation
Conditions studied
- Female Breast Cancer — all drugs for Female Breast Cancer →
Sponsor
University Of Perugia
Who can join
Adults 18 to 99, female only, with Female Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice. Patient population included women affected by early stage breast cancer (BC), both invasive and ductal carcinoma in situ, receiving ultra-hypofractionated WBI (with or without a tumor bed boost) after breast conserving surgery (BCS). Main exclusion criteria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. The primary otcome is acute and chronic toxicity evaluation. Secondary outcomes are: overall servival (OS), disease-free survival (DFS), rates of local and loco-regional recurrences, distant metastasis occurrence, cosmetic outcome and quality of life (QoL) assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0. Cosmetic assessment will be graded according to the Harvard scale. Frontal photographs of both breasts will be used to evaluate toxicity and cosmetic results. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 questionnaires will be administered.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
One-week regimen for postoperative regional irradiation in breast cancer: the ARROW trial protocol.
Xie J, Zheng S, Qi WX, Gan L, et al · · 2025 · PMID 40379319 · DOI 10.1136/bmjopen-2024-096677
Verify or expand the search:
- PubMed search for NCT05586256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05586256 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Of Perugia
- Last refreshed: 19 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05586256.
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