Breast CancerONCOTYPENCT06046664
Oncotype DX DCIS: Impact on Radiotherapy Decision Making
A study testing ONCOTYPE DX DCIS test in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Prospective single centre study of patients with DCIS that have undergone breast conservation surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ONCOTYPE DX DCIS test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of DCIS
- DCIS treated with breast conserving surgery
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- ONCOTYPE DX DCIS test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCOTYPE DX DCIS testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| DCIS Test | Other | Not described Receives: Diagnostic Test: ONCOTYPE DX DCIS test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiotherapy recommendation by clinician
Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.
Measured: 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.
Percentage of patients who change their decision regarding radiotherapy pre- and post- Oncotype DX DCIS.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: end of trial (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 Jul 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046664
- Sponsor's protocol ID
- CCR4963
- Acronym
- ONCOTYPE
- Status last verified
- Sep 2023
- First submitted
- 17 Jan 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom
- ClinicalTrials.gov ID
- NCT06046664
- Acronym / sponsor ID
- ONCOTYPE / CCR4963
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 oncologists in patients with low to moderate risk DCIS following breast conserving surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCIS Test | Other | Diagnostic Test: ONCOTYPE DX DCIS test |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of DCIS
- DCIS treated with breast conserving surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONCOTYPE DX DCIS testThe 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. | Diagnostic test | DCIS Test |
Primary outcome
Change in radiotherapy recommendation by clinician
Time frame: end of trial (2 years)
Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.
7 secondary outcomes
Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.
Time frame: 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).
Time frame: end of trial (2 years)
Determine change in patient decisional conflict pre and post Oncotype DX DCIS.
Time frame: end of trial (2 years)
Determine change in patient anxiety pre and post Oncotype DX DCIS.
Time frame: end of trial (2 years)
Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy.
Time frame: end of trial (2 years)
Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy.
Time frame: end of trial (2 years)
Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy.
Time frame: end of trial (2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONCOTYPE DX DCIS test in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in radiotherapy recommendation by clinician (time frame: end of trial (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.