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

A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: ONCOTYPE DX DCIS test

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 oncologists in patients with low to moderate risk DCIS following breast conserving surgery.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: DCIS Test

Diagnostic test: ONCOTYPE DX DCIS test; The Oncotype DX DCIS score, comprised of 12 of the 21 genes of the Oncotype DX Recurrence score, has been developed by Genomic Health Inc. Two clinical utility studies have now been performed in USA, assessing the value of the Oncotype DX DCIS to clinical decision making (18,19) The first study by Alvarado et al. evaluated the influence of the test in 10 centres and in 115 patients (18). The DCIS score led to a change in the treatment recommendation in 36 patients (31.3%; 26 patients had a change to no radiation and 10 patients had a change to recommend radiation). The second study similarly showed change in recommendations following the Oncotype DX DCIS test in 26.4% of cases. It is unclear what the impact of the DCIS score test would be in the UK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in radiotherapy recommendation by clinician	Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.	end of trial (2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.	Percentage of patients who change their decision regarding radiotherapy pre- and post- Oncotype DX DCIS.	end of trial (2 years)
Determine whether the local recurrence risk estimated by clinical oncologists agrees with the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only).	Agreement between the local recurrence risk estimated by clinical oncologists and the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only).	end of trial (2 years)
Determine change in patient decisional conflict pre and post Oncotype DX DCIS.	Change in patient decisional conflict scale (DCS) scores pre and post Oncotype DX DCIS	end of trial (2 years)
Determine change in patient anxiety pre and post Oncotype DX DCIS.	Change in state anxiety and trait anxiety scores using the State Trait Anxiety Inventory (STAI) pre and post ONCOTYPE DX DCIS test	end of trial (2 years)
Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy.	Patient, tumour and clinician factors (data collected during Visit 1) that are associated with clinicians changing their decision regarding radiotherapy.	end of trial (2 years)
Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy.	Patient, tumour and clinician related factors (data collected during Visit 1) that are associated with patients changing their decision regarding radiotherapy.	end of trial (2 years)
Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy.	Patient, tumour and clinician factors that are associated with patients' final decision to have radiotherapy.	end of trial (2 years)

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CCR4963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No