Titre Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features
Protocole ID ELISA
ClinicalTrials.gov ID NCT04797299
Type(s) de cancer Sein
Phase Autres
Type étude Autre
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DE L'ENFANT-JESUS
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dre Valérie Théberge
Coordonnateur(trice) Josée Allard
 418-525-4444 poste 67296
Statut Actif en recrutement
Critètes d'éligibilité
  • Female patient > 45 years of age with DCIS without microinvasion.
  • Tumour size ≤ 2.5cm.
  • Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.
  • Oncotype DX DCIS score < 39 and predicted 10-year risk of LR <10%.
Critètes d'exclusion
  • Multifocal DCIS.
  • History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
  • Synchronous or previous invasive or non-invasive breast cancer.
  • Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
  • ECOG performance status ≥3.
  • Life expectancy <10 years.
  • Geographic inaccessibility for follow-up.
  • Inability to provide informed consent.