RecruitingNot Applicable

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

Canada526 participantsStarted 2022-11-23

Plain-language 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)

Who can participate

Age range

46 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female patient \> 45 years of age with DCIS without microinvasion.
. Tumour size ≤ 2.5cm.
. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\*
. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ipsilateral local recurrence (LR)

Timeframe: 5 Year

Trial details

NCT IDNCT04797299

SponsorOntario Clinical Oncology Group (OCOG)

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-11-30

Contact for this trial

Brittany Speller

905-527-2299 spelleb@mcmaster.ca

View on ClinicalTrials.gov More DCIS trials