Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

ConditionDCIS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age46+
SponsorOntario Clinical Oncology Group (OCOG)

About this trial

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)

Eligibility criteria

Qualifiers

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%.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

526 Participants
are grouped into 1 trial group

Sponsors and collaborators

Ontario Clinical Oncology Group (OCOG)

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Hamilton Health Sciences Corporation

Collaborator