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

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ClinicalTrials.gov Identifier: NCT01316328
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Regina Elena Cancer Institute

March 15, 2011
March 16, 2011
March 16, 2011
May 2010
December 2010   (Final data collection date for primary outcome measure)
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No Changes Posted
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Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
breast cancer (BC) patients following single shot partial breast irradiation(SSPBI) after breast conservative surgery
Breast Cancer
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BC patients after SSPBI
breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
48 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01316328
IFO-84/10
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Regina Elena Cancer Institute
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Regina Elena Cancer Institute
December 2010