Status:
UNKNOWN
Oncotype DX DCIS: Impact on Radiotherapy Decision Making
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.
Detailed 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 onc...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of DCIS
- DCIS treated with breast conserving surgery
Exclusion
- Prior treatment for DCIS or invasive breast cancer in ipsilateral breast.
- Patients with contra-indications to radiotherapy, including prior breast radiotherapy
- Patients who undergo mastectomy for DCIS
- Age \< 45 years old
- Patients with \> 25mm DCIS
- Patients with multifocal DCIS (defined as more than 1 distinct focus of DCIS with at least 50mm of intervening benign tissue)
- Patients with invasive (including microinvasion) disease
- Patients with positive axillary nodal disease (including isolated tumour cells)
- Patients with close (\<1mm) or positive radial margins (unless maximally surgically excised or no further DCIS on re-excision)
- Patients recommended adjuvant endocrine therapy
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06046664
Start Date
July 7 2020
End Date
December 31 2023
Last Update
September 21 2023
Active Locations (1)
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1
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ