Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
DCISTo evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)
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Participation Requirements
-
Sex:
FEMALE -
Eligible Ages:
46 and up
Participation Criteria
Inclusion Criteria:
1. Female patient \> 45 years of age with DCIS without microinvasion.
2. Tumour size ≤ 2.5cm.
3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\*
\* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.
Exclusion Criteria:
1. Multifocal DCIS.
2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
3. Synchronous or previous invasive or non-invasive breast cancer.
4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
5. ECOG performance status ≥3.
6. Life expectancy \<10 years.
7. Geographic inaccessibility for follow-up.
Study Location
Arthur J.E. Child Comprehensive Cancer Centre
Arthur J.E. Child Comprehensive Cancer CentreCalgary, Alberta
Canada
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BC Cancer - Fraser Valley Centre
BC Cancer - Fraser Valley CentreSurrey, British Columbia
Canada
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Cape Breton Cancer Centre
Cape Breton Cancer CentreSydney, Nova Scotia
Canada
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Sunnybrook Health Science Centre -Odette Cancer Centre
Sunnybrook Health Science Centre -Odette Cancer CentreToronto, Ontario
Canada
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Jewish General Hospital
Jewish General HospitalMontréal, Quebec
Canada
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BC Cancer - Centre for the North (Prince George)
BC Cancer - Centre for the North (Prince George)Prince George, British Columbia
Canada
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QE II HSC - Nova Scotia Cancer Centre
QE II HSC - Nova Scotia Cancer CentreHalifax, Nova Scotia
Canada
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Regional Cancer Care, Thunder Bay Regional Health Sciences Centre
Regional Cancer Care, Thunder Bay Regional Health Sciences CentreThunder Bay, Ontario
Canada
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CHUM - Centre Hospitalier de L'Université de Montréal
CHUM - Centre Hospitalier de L'Université de MontréalMontreal, Quebec
Canada
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Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-RivièresTrois-Rivières, Quebec
Canada
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Cross Cancer Institute
Cross Cancer InstituteEdmonton, Alberta
Canada
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BC Cancer - Vancouver Centre
BC Cancer - Vancouver CentreVancouver, British Columbia
Canada
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Juravinski Cancer Centre
Juravinski Cancer CentreHamilton, Ontario
Canada
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University Health Network - Princess Margaret Cancer Centre
University Health Network - Princess Margaret Cancer CentreToronto, Ontario
Canada
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McGill University Health Centre
McGill University Health CentreMontréal, Quebec
Canada
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BC Cancer - Abbotsford Centre
BC Cancer - Abbotsford CentreAbbotsford, British Columbia
Canada
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BC Cancer - Victoria
BC Cancer - VictoriaVictoria, British Columbia
Canada
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London Regional Cancer Program
London Regional Cancer ProgramLondon, Ontario
Canada
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Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)
Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)Greenfield Park, Quebec
Canada
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Centre intégré de cancérologie du CHU de Québec - Université Laval
Centre intégré de cancérologie du CHU de Québec - Université LavalQuébec City, Quebec
Canada
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- Study Sponsored By
- Ontario Clinical Oncology Group (OCOG)
- Participants Required
- More Information
- Study ID:
NCT04797299