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

Last updated: May 6, 2025
Sponsor: Ontario Clinical Oncology Group (OCOG)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Cancer

Carcinoma

Precancerous Condition

Treatment

N/A

Clinical Study ID

NCT04797299
OCOG-2021-ELISA
  • Ages > 46
  • Female

Study 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 Criteria

Inclusion

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 onre-excision.*

  • Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if thedissection was confirmed to be taken to skin and down to fascia with no DCIS presentat inked margins.
  1. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion

Exclusion Criteria:

  1. Multifocal DCIS.

  2. History of any invasive breast cancer or non-invasive breast cancer in theipsilateral breast.

  3. Synchronous or previous invasive or non-invasive breast cancer.

  4. Prior history of invasive cancer within the last 5 years, excluding non-melanomaskin cancers.

  5. ECOG performance status ≥3.

  6. Life expectancy <10 years.

  7. Geographic inaccessibility for follow-up.

Study Design

Total Participants: 526
Study Start date:
November 23, 2022
Estimated Completion Date:
May 31, 2035

Study Description

A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. We plan to screen 809 consenting women who will have their tumour tissue specimen sent to Exact Sciences to assess their DCIS score. We anticipate that 526 women will have an Oncotype DX DCIS score with a predicted 10-year risk of local recurrence ≤10%, these women will be enrolled and followed as part of the study.

At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. A two-step registration/enrollment process will be implemented.

Data related to the patient demographics, surgery details, tumour characteristics and ECOG performance will be collected. The patient's tumour specimen will be sent for analysis to Exact Sciences. The DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. Patients will be followed yearly up to 10 years. Bilateral mammograms and breast exams will be performed annually. The study data will be verified by source documentation.

Connect with a study center

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • BC Cancer - Abbotsford Centre

    Abbotsford, British Columbia V2S 0C2
    Canada

    Active - Recruiting

  • BC Cancer - Centre for the North (Prince George)

    Prince George, British Columbia V2M 7E9
    Canada

    Active - Recruiting

  • BC Cancer - Fraser Valley Centre

    Surrey, British Columbia V3V 1Z2
    Canada

    Active - Recruiting

  • BC Cancer - Vancouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BC Cancer - Victoria

    Victoria, British Columbia V8R 6V5
    Canada

    Active - Recruiting

  • QE II HSC - Nova Scotia Cancer Centre

    Halifax, Nova Scotia B3H 1V7
    Canada

    Active - Recruiting

  • Cape Breton Cancer Centre

    Sydney, Nova Scotia B1P 1P3
    Canada

    Active - Recruiting

  • Juravinski Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Active - Recruiting

  • Cancer Centre of Southeastern Ontario, Kingston General Hospital

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • London Regional Cancer Program

    London, Ontario N6A 4L6
    Canada

    Active - Recruiting

  • Walker Family Cancer Centre, Niagara Health System,St. Catharines

    St. Catharines, Ontario L2S 0A9
    Canada

    Site Not Available

  • Regional Cancer Care, Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario P7B 6V4
    Canada

    Active - Recruiting

  • Sunnybrook Health Science Centre -Odette Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Windsor Regional Cancer Centre

    Windsor, Ontario N8W 2X3
    Canada

    Active - Recruiting

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

    Greenfield Park, Quebec J4V 2H1
    Canada

    Active - Recruiting

  • CHUM - Centre Hospitalier de L'Université de Montréal

    Montreal, Quebec H2L 4M1
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montréal, Quebec H3T 1E2
    Canada

    Site Not Available

  • McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Centre intégré de cancérologie du CHU de Québec - Université Laval

    Québec City, Quebec G1J 1Z4
    Canada

    Active - Recruiting

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

    Trois-Rivières, Quebec G8Z 3R9
    Canada

    Active - Recruiting

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