Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery

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%.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

48 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Regina Elena NCI

Rome, 00144, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Acronym: HYPOPRONE

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 16, 2011
Registry last updated: Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed