Status:
RECRUITING
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Conditions:
DCIS
Eligibility:
FEMALE
46+ years
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...
Detailed Description
A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very ...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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.
Key Trial Info
Start Date :
November 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2035
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT04797299
Start Date
November 23 2022
End Date
November 30 2035
Last Update
September 25 2025
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
BC Cancer - Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
4
BC Cancer - Centre for the North (Prince George)
Prince George, British Columbia, Canada, V2M 7E9