Recruiting

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

Sponsor:

Ontario Clinical Oncology Group (OCOG)

Code:

NCT04797299

Conditions

DCIS

Eligibility Criteria

Sex: Female

Age: 46+

Healthy Volunteers: Not accepted

Study Details

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)

Conditions

DCIS

Study ID

NCT04797299

Start date

Nov 23, 2022

Status verified date

Jun, 2026

Completion date

Nov 30, 2035

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Sex: Female

Age: 46+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Female patient > 45 years of age with DCIS without microinvasion.
2. Tumour size ≤ 2.5cm.
3. 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.
4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion Criteria:

1. Multifocal DCIS.
2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
3. Synchronous or previous invasive or non-invasive breast cancer.
4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
5. ECOG performance status ≥3.
6. Life expectancy <10 years.
7. Geographic inaccessibility for follow-up.

Study Design

Enrollment

526 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

Ipsilateral local recurrence (LR) [ Time Frame: 5 Year ]

Central Contacts and Locations

Central contacts

Brittany Speller

905-527-2299 spelleb@mcmaster.ca

Locations

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Osita Muoto

osita.muoto@cancercarealberta.ca

Principal Investigator:

Jeffrey Q Cao, MD

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Andrea Rosario

Andrea.Rosario@albertahealthservices.ca

Principal Investigator:

Kurian Joseph, MD

BC Cancer - Abbotsford Centre

Recruiting

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

Contacts

Sukhpreet Sidhu

604-851-4710 sukhpreet.sidhu@bccancer.bc.ca

Principal Investigator:

Maha Almahmudi, MD

BC Cancer - Centre for the North (Prince George)

Recruiting

Prince George, British Columbia, Canada, V2M 7E9

Contacts

Kaitlin Earl

Kaitlin.Earl@bccancer.bc.ca

Principal Investigator:

Robert Olson, MD

BC Cancer - Fraser Valley Centre

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Noelle Baird

604-587-4315 nebaird@bccancer.bc.ca

Principal Investigator:

Dylan Narinesingh, MD

BC Cancer - Vancouver Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Fermin Hoq

fermin.hoq1@bccancer.bc.ca

Principal Investigator:

Iwa Kong, MD

BC Cancer - Victoria

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Contacts

Sarah Egli

sarah.egli@bccancer.bc.ca

Principal Investigator:

David Wu, MD

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Abdullah Ghazi

204-787-2416 aghazi@cancercare.mb.ca

Principal Investigator:

Abdulmajeed Dayyat, MD

QE II HSC - Nova Scotia Cancer Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Madison Boudreau

madison.boudreau@nshealth.ca

Jennifer Patriquin

Jennifer.patriquin@nshealth.ca

Principal Investigator:

Robert Rutledge, MD

Cape Breton Cancer Centre

Recruiting

Sydney, Nova Scotia, Canada, B1P 1P3

Contacts

Taegen McPhee

taegen.mcphee@nshealth.ca

Chantelle McMullin

chantelle.mcmullin@nshealth.ca

Principal Investigator:

Kwamena Beecham, MD

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Christine Di Marco

705-728-9090 dimarcoc@rvh.on.ca

Rachelle Beausoleil

705-728-9090 beausoleilr@rvh.on.ca

Principal Investigator:

Christiaan Stevens, MD

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Noshaba Qasmi

qasmi@hhsc.ca

Principal Investigator:

Tim Whelan, MD

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 4L6

Contacts

Amanda Anderson

amanda.anderson@lhsc.on.ca

Principal Investigator:

Francisco Perera, MD

Regional Cancer Care, Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Contacts

Di-anne Salo

di-anne.salo@tbh.net

Principal Investigator:

Margaret Anthes, MD

Sunnybrook Health Science Centre -Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Naema Yousuf

naema.yousuf@sunnybrook.ca

Ivy San Juan

ivy.sanjuan@sunnybrook.ca

Principal Investigator:

Eileen Rakovitch, MD

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Lea Dungao

lea.dungao@rmp.uhn.on.ca

Principal Investigator:

Ezra Hahn, MD

Windsor Regional Cancer Centre

Recruiting

Windsor, Ontario, Canada, N8W 2X3

Contacts

Donna Clinansmith

519-253-5253 donna.clinansmith@wrh.on.ca

Principal Investigator:

Padma Muruganandam, MD

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

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Contacts

Caroline Hivon

caroline.hivon.cisssmc16@ssss.gouv.qc.ca

Principal Investigator:

Nancy El-Bared, MD

CHUM - Centre Hospitalier de L'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2L 4M1

Contacts

Camille Paquet

camille.paquet.rech.chum@ssss.gouv.qc.ca

Principal Investigator:

Jean-Marc Bourque, MD

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Marianna Perna

marianna.perna@muhc.mcgill.ca

Principal Investigator:

Christine Lambert, MD

Centre intégré de cancérologie du CHU de Québec - Université Laval

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Josée Allard

Josee.Allard@chudequebec.ca

Principal Investigator:

Valérie Théberge, MD

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

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Contacts

Marie-Eve Caron

marie-eve_caron_chrtr@ssss.gouv.qc.ca

Principal Investigator:

Francois Vincent, MD

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Bailey Kowalski

306-766-2972 Bailey.Kowalski@saskcancer.ca

Bernadette Procyk

bernadette.procyk@saskcancer.ca

Principal Investigator:

Shazia Mahmood, MD

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N4H4

Contacts

Savannah Drapak

306-655-2461 savannah.drapak@saskcancer.ca

Principal Investigator:

Philip Wright, MD

More Information

Sponsor

Ontario Clinical Oncology Group (OCOG)

Last update posted

Aug 14, 2026

Last verified

Jun, 2026

Keywords

Ductal Carcinoma in Situ
Breast Conserving Surgery
Oncotype DX DS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Clinical Oncology Group (OCOG) on 2026-08-14.