Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
ELISA
1 other identifier
observational
526
1 country
24
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2035
September 25, 2025
September 1, 2025
8 years
March 10, 2021
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ipsilateral local recurrence (LR)
Defined as recurrent invasive or in situ cancer in the ipsilateral breast
5 Year
Secondary Outcomes (5)
Ipsilateral invasive local recurrence
5 Year
Breast cancer recurrence-free interval (RFI)
5 Year
Distant disease-free survival (DDFS)
5 Year
Disease-free survival (DFS)
5 Year
Overall survival (OS)
5 Year
Study Arms (1)
Single Arm Cohort
Evaluating the risk of Local Recurrence (LR) in a group of women postulated to be at low risk of LR following Breast Conserving Surgery alone defined by a combination of clinicopathological factors and Oncotype DX DCIS score.
Eligibility Criteria
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
You may qualify if:
- 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.\*
- \* 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.
- Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer - Abbotsford Centre
Abbotsford, British Columbia, V2S 0C2, Canada
BC Cancer - Centre for the North (Prince George)
Prince George, British Columbia, V2M 7E9, Canada
BC Cancer - Fraser Valley Centre
Surrey, British Columbia, V3V 1Z2, Canada
BC Cancer - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
BC Cancer - Victoria
Victoria, British Columbia, V8R 6V5, Canada
QE II HSC - Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1P3, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Regional Cancer Care, Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Sunnybrook Health Science Centre -Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)
Greenfield Park, Quebec, J4V 2H1, Canada
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, H2L 4M1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre intégré de cancérologie du CHU de Québec - Université Laval
Québec, Quebec, G1J 1Z4, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N4H4, Canada
Related Links
Biospecimen
Specimens will be used to determine Oncotype DX DCIS Score and subsequent testing for future correlative studies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen Rakovitch, M.D.
Sunnybrook Research Institute, Sunnybrook Health Science
- PRINCIPAL INVESTIGATOR
Tim Whelan, M.D
Juravinski Cancer Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 15, 2021
Study Start
November 23, 2022
Primary Completion (Estimated)
November 30, 2030
Study Completion (Estimated)
November 30, 2035
Last Updated
September 25, 2025
Record last verified: 2025-09