Actively Recruiting

Age: 46Years +
FEMALE
NCT04797299

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

Led by Ontario Clinical Oncology Group (OCOG) · Updated on 2025-09-25

526

Participants Needed

24

Research Sites

679 weeks

Total Duration

On this page

AI-Summary

What this Trial 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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 46Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patient over 45 years of age with DCIS without microinvasion
  • Tumor size 2.5 cm or less
  • Treated by breast conserving surgery with clear resection margins of at least 2 mm, or no residual disease on re-excision
  • Patients with anterior and posterior margins of at least 1 mm are eligible if dissection was confirmed to skin and fascia with no DCIS at inked margins
  • Oncotype DX DCIS score predicting a 10-year risk of local recurrence of 10% or less
Not Eligible

You will not qualify if you...

  • Multifocal DCIS
  • History of any invasive breast cancer or non-invasive breast cancer in the same breast
  • Synchronous or previous invasive or non-invasive breast cancer
  • Prior invasive cancer within the last 5 years, excluding non-melanoma skin cancers
  • ECOG performance status 3 or higher
  • Life expectancy less than 10 years
  • Geographic inaccessibility for follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

3

BC Cancer - Abbotsford Centre

Abbotsford British Columbia, British Columbia, Canada, V2S 0C2

Actively Recruiting

4

BC Cancer - Centre for the North (Prince George)

Prince George, British Columbia, Canada, V2M 7E9

Actively Recruiting

5

BC Cancer - Fraser Valley Centre

Surrey, British Columbia, Canada, V3V 1Z2

Actively Recruiting

6

BC Cancer - Vancouver Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

7

BC Cancer - Victoria

Victoria, British Columbia, Canada, V8R 6V5

Actively Recruiting

8

QE II HSC - Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada, B3H 1V7

Actively Recruiting

9

Cape Breton Cancer Centre

Sydney, Nova Scotia, Canada, B1P 1P3

Actively Recruiting

10

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

Actively Recruiting

11

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

Actively Recruiting

12

London Regional Cancer Program

London, Ontario, Canada, N6A 4L6

Actively Recruiting

13

Regional Cancer Care, Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada, P7B 6V4

Actively Recruiting

14

Sunnybrook Health Science Centre -Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

15

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

16

Windsor Regional Cancer Centre

Windsor, Ontario, Canada, N8W 2X3

Actively Recruiting

17

Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)

Greenfield Park, Quebec, Canada, J4V 2H1

Actively Recruiting

18

CHUM - Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, Canada, H2L 4M1

Actively Recruiting

19

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Withdrawn

20

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

21

Centre intégré de cancérologie du CHU de Québec - Université Laval

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

22

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières

Trois-Rivières, Quebec, Canada, G8Z 3R9

Actively Recruiting

23

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada, S4T 7T1

Actively Recruiting

24

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada, S7N4H4

Actively Recruiting

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Research Team

A

Adrianne Van Dam

CONTACT

D

Daryl Hannah Soloman

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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