Groupe d'Etude en Oncologie du Quebec

Title	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
Cancer Type(s)	Breast
Phase	Other
Stage
Study Type	Other
Drug
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
City
Principal Investigator	Dr. Jean-Marc Bourque
Coordinator	Silvine Benth 514-890-8000
Status	Recruiting
Activation Date	20-06-2024
Eligibility Criteria	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%.
Exclusion Criteria	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.

Groupe d'étude en oncologie du Québec