Sein

TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT04797299
TYPE(S) DE CANCER Sein
PHASE Autres
TYPE D'ÉTUDE Autre
INSTITUTION CHUM
1051 rue Sanguinet
(514) 890-8000
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jean-Marc Bourque
COORDONATEUR(RICE) Silvine Benth
silvine.benth.chum@ssss.gouv.qc.ca
514-890-8000
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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%.
CRITÈRES D'EXCLUSION (EN)
  • 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.