RecruitingNCT04797299

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

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features

Sponsor

Ontario Clinical Oncology Group (OCOG)

Enrollment

526 participants

Start Date

Nov 23, 2022

Study Type

OBSERVATIONAL

Conditions

DCIS

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)

Eligibility

Sex: FEMALEMin Age: 46 Years

Plain Language Summary

Simplified for easier understanding

This trial is for women with low-risk ductal carcinoma in situ (DCIS) — a very early, non-invasive form of breast cancer — to see whether breast-conserving surgery alone (without radiation or hormone therapy) is safe and effective. Standard care after DCIS surgery often includes radiation, but researchers believe a select group of women may not need it. **You may be eligible if...** - You are a woman over 45 - You have DCIS without microinvasion (cancer cells have not broken through the duct walls) - Your tumor is 2.5 cm or smaller - You have had breast-conserving surgery with clear margins (at least 2 mm of healthy tissue around the cancer, or no residual disease) - Your DCIS has a low recurrence risk score on the Oncotype DX DCIS test (predicted 10-year risk ≤10%) **You may NOT be eligible if...** - Your tumor is larger than 2.5 cm - Your surgical margins are not clear - Your Oncotype DX DCIS score shows a higher recurrence risk - You have multiple tumors or other high-risk features Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(24)

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

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

London Regional Cancer Program

London, Ontario, Canada

Regional Cancer Care, Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Sunnybrook Health Science Centre -Odette Cancer Centre

Toronto, Ontario, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

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

Greenfield Park, Quebec, Canada

CHUM - Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec - Université Laval

Québec, Quebec, Canada

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

Trois-Rivières, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

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NCT04797299

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