Oncotype DX DCIS: Impact on Radiotherapy Decision Making

NCT06046664 | Unknown

• 1 other identifier: CCR4963
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.

  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).

  end of trial (2 years)

• Determine change in patient decisional conflict pre and post Oncotype DX DCIS.

  end of trial (2 years)

• Determine change in patient anxiety pre and post Oncotype DX DCIS.

  end of trial (2 years)

• Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy.

  end of trial (2 years)

Study Arms (1)

DCIS Test

OTHER

Diagnostic Test: ONCOTYPE DX DCIS test

Interventions

ONCOTYPE DX DCIS test DIAGNOSTIC_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.

DCIS Test

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of DCIS
• DCIS treated with breast conserving surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: September 21, 2023
• Study Start: July 7, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)