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

What this study is about

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)

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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.

Where this trial is running

• Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
• Cross Cancer Institute, Edmonton, Alberta, Canada
• BC Cancer - Abbotsford Centre, Abbotsford British Columbia, British Columbia, Canada
• BC Cancer - Centre for the North (Prince George), Prince George, British Columbia, Canada
• BC Cancer - Fraser Valley Centre, Surrey, British Columbia, Canada
• BC Cancer - Vancouver Centre, Vancouver, British Columbia, Canada
• BC Cancer - Victoria, Victoria, British Columbia, Canada
• CancerCare Manitoba, Winnipeg, Manitoba, Canada
• QE II HSC - Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
• Cape Breton Cancer Centre, Sydney, Nova Scotia, Canada
• Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
• Juravinski Cancer Centre, Hamilton, Ontario, Canada

+ 13 more sites.

Who to contact

Brittany Speller · 905-527-2299 · spelleb@mcmaster.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04797299.