Oncotype DX DCIS: Impact on Radiotherapy Decision Making (ONCOTYPE)

Royal Marsden NHS Foundation Trust

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Diagnostic Test: ONCOTYPE DX DCIS test

Study type: Interventional

Funder types: Other

Identifiers

NCT06046664

CCR4963

Details and patient eligibility

About

Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.

Full description

This is a single centre (Royal Marsden Hospital - Chelsea and Sutton) non-randomised trial investigating whether the Oncotype DX DCIS score changes the radiotherapy recommendation made by clinical oncologists in patients with low to moderate risk DCIS following breast conserving surgery.

Enrollment: 78 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of DCIS
2. DCIS treated with breast conserving surgery

Exclusion criteria

1. Prior treatment for DCIS or invasive breast cancer in ipsilateral breast.
2. Patients with contra-indications to radiotherapy, including prior breast radiotherapy
3. Patients who undergo mastectomy for DCIS
4. Age < 45 years old
5. Patients with > 25mm DCIS
6. Patients with multifocal DCIS (defined as more than 1 distinct focus of DCIS with at least 50mm of intervening benign tissue)
7. Patients with invasive (including microinvasion) disease
8. Patients with positive axillary nodal disease (including isolated tumour cells)
9. Patients with close (<1mm) or positive radial margins (unless maximally surgically excised or no further DCIS on re-excision)
10. Patients recommended adjuvant endocrine therapy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

DCIS Test

Other group

Treatment:

Diagnostic Test: ONCOTYPE DX DCIS test