Clinical trial · Observational
Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery
- 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)
The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase II "single-arm study". The use of a single dose tumor bed is expected to be very effective in terms of tumor control, but it could increase the incidence of radiation induced erythema. Therefore, the investigators assumed that a decreased DNA repair capability, as well as a reduced detoxification of the damage caused by oxidative stress could explain the increased acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage repair pathways such as GST, XRCC1, XRCC3 and RAD51. The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high risk, respectively, (groups were identified based on the absence/presence of the above polymorphisms alone or in combination), thus the minimum sample size was 56 patients with α=0.05, 2-tailed test and a power of the study of 80%.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- BC patients after SSPBI
- description
- breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 48 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 48 years old with a life expectancy of at least 5 years * Post-menopausal status * Histologically proven, non lobular, adenocarcinoma of the breast * Primary tumours ≤ 3 cm * Negative surgical margins (≥ 2 mm) * Negative sentinel nodes or \< 4 positive axillary nodes * No extra-capsular extension * No previous radiotherapy Exclusion Criteria: * multicentric disease * extended intraductal component (EIC \> 25%) * Paget's disease * lobular adenocarcinoma * distant metastases All the above criteria allow to identify patients at low risk of local recurrence.
References
Publications (3)
- DERIVEDFalvo E, Strigari L, Citro G, Giordano C, Boboc G, Fabretti F, Bruzzaniti V, Bellesi L, Muti P, Blandino G, Pinnaro P. SNPs in DNA repair or oxidative stress genes and late subcutaneous fibrosis in patients following single shot partial breast irradiation. J Exp Clin Cancer Res. 2012 Jan 24;31(1):7. doi: 10.1186/1756-9966-31-7. PMID 22272830
- DERIVEDPinnaro P, Arcangeli S, Giordano C, Arcangeli G, Impiombato FA, Pinzi V, Iaccarino G, Soriani A, Landoni V, Strigari L. Toxicity and cosmesis outcomes after single fraction partial breast irradiation in early stage breast cancer. Radiat Oncol. 2011 Nov 11;6:155. doi: 10.1186/1748-717X-6-155. PMID 22079051
- DERIVEDFalvo E, Strigari L, Citro G, Giordano C, Arcangeli S, Soriani A, D'Alessio D, Muti P, Blandino G, Sperduti I, Pinnaro P. Dose and polymorphic genes xrcc1, xrcc3, gst play a role in the risk of articledeveloping erythema in breast cancer patients following single shot partial breast irradiation after conservative surgery. BMC Cancer. 2011 Jul 12;11:291. doi: 10.1186/1471-2407-11-291. PMID 21749698