Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
Recruiting now
Conditions studied: DCIS
In brief
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)
Key facts
- Study ID
- NCT04797299
- Run by
- Ontario Clinical Oncology Group (OCOG)
- People needed
- 526
- Starts
- 2022-11-23
- Expected to finish
- 2035-11-30
- Last updated by the study team
- 2026-07-17
Who can join
Age: 46 and older. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada (enrolling)
- Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
- BC Cancer - Abbotsford Centre — Abbotsford British Columbia, British Columbia, Canada (enrolling)
- BC Cancer - Centre for the North (Prince George) — Prince George, British Columbia, Canada (enrolling)
- BC Cancer - Fraser Valley Centre — Surrey, British Columbia, Canada (enrolling)
- BC Cancer - Vancouver Centre — Vancouver, British Columbia, Canada (enrolling)
- BC Cancer - Victoria — Victoria, British Columbia, Canada (enrolling)
- CancerCare Manitoba — Winnipeg, Manitoba, Canada (enrolling)
- QE II HSC - Nova Scotia Cancer Centre — Halifax, Nova Scotia, Canada (enrolling)
- Cape Breton Cancer Centre — Sydney, Nova Scotia, Canada (enrolling)
- Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (enrolling)
- Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
- London Regional Cancer Program — London, Ontario, Canada (enrolling)
- Regional Cancer Care, Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (enrolling)
- Sunnybrook Health Science Centre -Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- Windsor Regional Cancer Centre — Windsor, Ontario, Canada (enrolling)
- Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre) — Greenfield Park, Quebec, Canada (enrolling)
- CHUM - Centre Hospitalier de L'Université de Montréal — Montreal, Quebec, Canada (enrolling)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (enrolling)
- McGill University Health Centre — Montreal, Quebec, Canada (enrolling)
- Centre intégré de cancérologie du CHU de Québec - Université Laval — Québec, Quebec, Canada (enrolling)
- Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières — Trois-Rivières, Quebec, Canada (enrolling)
- Allan Blair Cancer Centre — Regina, Saskatchewan, Canada (enrolling)
- Jewish General Hospital — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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