To 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)
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 with a predicted 10-year risk of LR ≤10%.
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.
Prospective cohort study conducted in Canada in women with a low risk DCIS following breast conserving surgery who are candidates for radiation. Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment
Cohort
Prospective
Not listed
Ipsilateral local recurrence (LR)
Defined as recurrent invasive or in situ cancer in the ipsilateral breast
Ipsilateral invasive local recurrence
defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast
Breast cancer recurrence-free interval (RFI)
defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer
Distant disease-free survival (DDFS)
defined as time from study registration to distant recurrence
Disease-free survival (DFS)
defined as time from registration to time of LR (DCIS or invasive), regional and distant recurrence, contralateral breast cancer, new primary (non-breast) and death from any cause
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Ontario Clinical Oncology Group (OCOG)
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Hamilton Health Sciences Corporation
Collaborator
