Clinical trial · Interventional
Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer
Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
NCT04679454CI-TRIAL-00079458recruitingN/AClinicalTrials.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 phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phase I | Radiation | — | UNRESOLVED |
| Phase II | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative Radiation Treatment
- description
- Preoperative Radiation treatment with CyberKnife
- interventionNames
- Radiation: Phase I
- Radiation: Phase II
Primary outcomes (2)
- measure
- Phase I: Identify the maximum tolerated dose (MTD)
- timeFrame
- time frame:2 weeks
- description
- Dose escalation is designed as a 3+3 rule-based study. Acute skin/soft tissue toxicity, measured according to NCI CTCAE v. 4.03. Any Grade 3-4 toxicity related to radioablation is considered dose limiting (DLT).
- measure
- Phase II: Evaluate efficacy measured in terms of pCR rate
- timeFrame
- time frame:8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven unifocal adenocarcinoma * T1-T2 * Tumor size up to 2.5 cm * cN0 * Age ≥ 18 years old * Good general condition (ECOG 0-2) * Planned BCS * Written informed consent Exclusion Criteria: * Tumor close to skin or chest wall * Pure non-invasive tumor * Prior RT to the chest * Neoadjuvant chemotherapy * Collagenopathies * Coagulation or autoimmunitary disorders * Previous malignancies
References
Publications (2)
- DERIVEDZerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Gerardi MA, Fodor C, Rondi E, Vigorito S, Penco S, Sargenti M, Baratella P, Vicini E, Morigi C, Kahler-Ribeiro-Fontana S, Galimberti VE, Gandini S, De Camilli E, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. A narrative review for radiation oncologists to implement preoperative partial breast irradiation. Radiol Med. 2023 Dec;128(12):1553-1570. doi: 10.1007/s11547-023-01706-6. Epub 2023 Aug 31. PMID 37650981
- DERIVEDZerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Fodor C, Rondi E, Vigorito S, Botta F, Cremonesi M, Garibaldi C, Penco S, Galimberti VE, Intra M, Gandini S, Barberis M, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study - a phase I/II clinical trial protocol. BMC Cancer. 2022 Apr 2;22(1):358. doi: 10.1186/s12885-022-09305-w. PMID 35366825