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

Official record

Identifier

NCT04797299

Recruiting locations

country

Canada

Interventions studied

Not provided in the official record

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Target enrolment

526 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Recruiting

First posted

Mar 15, 2021

Last updated on the registry

Aug 14, 2026

Age

46 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Breast Cancer