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

Launched by ONTARIO CLINICAL ONCOLOGY GROUP (OCOG) · Mar 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether certain factors, along with a special test called the Oncotype DX DCIS score, can help determine if women with low-risk ductal carcinoma in situ (DCIS) can safely skip radiation therapy after having breast-conserving surgery. The goal is to find out if these women can avoid the additional treatment while still having good outcomes.

To participate in the study, women must be over 45 years old, have a tumor that is 2.5 cm or smaller, and have had surgery that successfully removed the cancer with clear margins. They also need a specific score from the Oncotype DX test that predicts a low risk of cancer returning. Participants can expect to be monitored closely during the trial, and their experiences will help doctors understand better treatment options for patients with low-risk DCIS. It’s important to know that women with previous breast cancer or certain other conditions won't be eligible for this trial.

Gender

FEMALE

Eligibility criteria

• 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.