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 CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Christine Lambert
COORDONATEUR(RICE) Gabriele Riva
gabriele.riva@mcgill.ca
514-398-6907
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.