PRE-DX – the impact of earlier genomic testing in the treatment of breast cancer

Pre-Operative Oncotype DX testing: A decision impact study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14337451

Enrollment

330

Registered

2022-08-16

Start date

2022-10-10

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer

Interventions

Current intervention as of 02/06/2023: As of Protocol V2.1 24/03/2023: The Oncotype DX is a prognostic test applied to guide the treatment of breast cancer. The Recurrence Score (RS) result informs re

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 02/06/2023: As of Protocol 2.1 (24/03/2023): 1. Aged =18 years 2. Oestrogen receptor positive HER2-negative invasive early-stage breast cancer confirmed on diagnostic core biopsy, as per definition of hormone receptor status in NICE DG34 guidance 3. Pre-operative staging of grade 2 cancer = 20 mm on all imaging modalities or grade 3 cancer of any size and N0 on axillary staging or any size or grade which is N1 on preoperative axillary ultrasound scan +/- FNA or core biopsy (If local reimbursement available for N1 patients oncotype) 3. Surgery planned as first definitive treatment 4. Fit for adjuvant chemotherapy 5. Able to provide written or remote (eConsent or postal) informed consent 6. Able to complete questionnaires and study assessments Participants receiving endocrine bridging therapy are eligible for the study provided the reason is due to a delay in planned surgery rather than for the purpose of downstaging the tumour. _____ Previous inclusion criteria: As per Protocol V1.1 (27/06/2022): 1. Aged =18 years 2. Oestrogen receptor positive HER2 negative invasive early stage breast cancer confirmed on diagnostic core biopsy, as per definition of hormone receptor status in NICE DG34 guidance 3. Pre-operative staging of grade 2 cancer >20 mm, or any grade 3 cancer >10 mm on all imaging modalities. N0 on axillary staging, or any size or grade which is N1 on preoperative axillary ultrasound scan +/- FNA or core biopsy (If local reimbursement available for N1 patients oncotype). 3. Surgery planned as first definitive treatment 4. Fit for adjuvant chemotherapy 5. Able to provide written or remote (eConsent or postal) informed consent 6. Able to complete questionnaires and study assessments

Exclusion criteria

Exclusion criteria: 1. ER negative or HER2 positive breast cancer 2. Grade 4 or N2 disease on pre-operative staging 3. Planned for neo-adjuvant systemic therapy 4. Unfit for surgical treatment or systemic chemotherapy 5. Are unable to provide informed consent 6. Have co-existing malignant disease only if this would affect the study in the investigator’s opinion 7. Are unable to complete study questionnaires even with the assistance of the study nurse 8. Are already participating in another clinical trial

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 15/08/2023: : As of Protocol 2.2 (04/07/2023): Number of participant touch points from the participant diagnosis (defined as the date of attendance at diagnostic clinic) to the offer and prescription of adjuvant cancer treatment measured using patient records at the time of the offer and prescription of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent) between the treating team and the participant. In the event of the participant declining further treatment the date of offer should be used. _____ Previous primary outcome measure as of 02/06/2023: As of Protocol 2.0 (07/02/2023): Number of participant touch points from the initial patient approach to the offer and prescription of adjuvant cancer treatment measured using patient records at the time of the offer and prescription of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent) between the treating team and the participant. In the event of the participant declining further treatment the date of offer should be used. _____ Previous primary outcome measure as of 28/11/2022: Number of participant touch points from the initial patient approach to the offer of adjuvant cancer treatment measured using patient records at the time of the offer of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent) between the treating team and the participant. _____ Previous primary outcome measures: 1. Number of participant touch points from the initial patient approach to the offer of adjuvant cancer treatment measured using patient records at the time of the offer of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent	—

Measure

Time frame

Current primary outcome measure as of 15/08/2023: : As of Protocol 2.2 (04/07/2023): Number of participant touch points from the participant diagnosis (defined as the date of attendance at diagnostic clinic) to the offer and prescription of adjuvant cancer treatment measured using patient records at the time of the offer and prescription of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent) between the treating team and the participant. In the event of the participant declining further treatment the date of offer should be used. _____ Previous primary outcome measure as of 02/06/2023: As of Protocol 2.0 (07/02/2023): Number of participant touch points from the initial patient approach to the offer and prescription of adjuvant cancer treatment measured using patient records at the time of the offer and prescription of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent) between the treating team and the participant. In the event of the participant declining further treatment the date of offer should be used. _____ Previous primary outcome measure as of 28/11/2022: Number of participant touch points from the initial patient approach to the offer of adjuvant cancer treatment measured using patient records at the time of the offer of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent) between the treating team and the participant. _____ Previous primary outcome measures: 1. Number of participant touch points from the initial patient approach to the offer of adjuvant cancer treatment measured using patient records at the time of the offer of adjuvant cancer treatment. Participant touch points will be defined as a participant-clinician interaction (outpatient appointment or equivalent

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 15/08/2023: As of Protocol 2.2 (04/07/2023): 1. Time in days between the participant diagnosis (defined as the date of attendance at diagnostic clinic) and the offer and prescription of adjuvant cancer treatment (chemotherapy, radiotherapy or endocrine therapy) 2. Time in days between the participant diagnosis (defined as the date of attendance at diagnostic clinic) and the start of the first adjuvant cancer treatment (chemotherapy, radiotherapy or endocrine therapy) 3. Alteration in the recommended treatment sequence. This is measured when a participant in the intervention arm receives neo-adjuvant treatment as the result of the Recurrence Score (RS) results from the core biopsy rather than proceeding directly to surgery. 4. Anxiety and depression symptoms measured using the Hospital Anxiety and Depression Score (HADS) at baseline, following the post-surgery clinic appointment, and following the offer of adjuvant treatment 5. Healthcare resource use measured using the patient-reported Health Resource Utilisation Questionnaire (HRUQ) completed following the post-surgery clinic appointment and following the offer of adjuvant treatment 6. Rate of failure of the Oncotype DX® assay (RS result cannot be issued) on diagnostic core biopsy specimen. This will be measured when a test on the diagnostic core biopsy specimen fails. _____ Previous secondary outcome measures as of 02/06/2023: As of Protocol 2.0 (07/02/2023): 1. Time in days between the participant diagnosis (defined as the date of attendance at diagnostic clinic) and the offer and prescription of adjuvant cancer treatment (chemotherapy, radiotherapy or endocrine therapy) 2. Alteration in the recommended treatment sequence. This is measured when a participant in the intervention arm receives neo-adjuvant treatment as the result of the Recurrence Score (RS) results from the core biopsy rather than proceeding directly to surgery. 3. Anxiety and depression symptoms measur	—

Measure

Time frame

Current secondary outcome measures as of 15/08/2023: As of Protocol 2.2 (04/07/2023): 1. Time in days between the participant diagnosis (defined as the date of attendance at diagnostic clinic) and the offer and prescription of adjuvant cancer treatment (chemotherapy, radiotherapy or endocrine therapy) 2. Time in days between the participant diagnosis (defined as the date of attendance at diagnostic clinic) and the start of the first adjuvant cancer treatment (chemotherapy, radiotherapy or endocrine therapy) 3. Alteration in the recommended treatment sequence. This is measured when a participant in the intervention arm receives neo-adjuvant treatment as the result of the Recurrence Score (RS) results from the core biopsy rather than proceeding directly to surgery. 4. Anxiety and depression symptoms measured using the Hospital Anxiety and Depression Score (HADS) at baseline, following the post-surgery clinic appointment, and following the offer of adjuvant treatment 5. Healthcare resource use measured using the patient-reported Health Resource Utilisation Questionnaire (HRUQ) completed following the post-surgery clinic appointment and following the offer of adjuvant treatment 6. Rate of failure of the Oncotype DX® assay (RS result cannot be issued) on diagnostic core biopsy specimen. This will be measured when a test on the diagnostic core biopsy specimen fails. _____ Previous secondary outcome measures as of 02/06/2023: As of Protocol 2.0 (07/02/2023): 1. Time in days between the participant diagnosis (defined as the date of attendance at diagnostic clinic) and the offer and prescription of adjuvant cancer treatment (chemotherapy, radiotherapy or endocrine therapy) 2. Alteration in the recommended treatment sequence. This is measured when a participant in the intervention arm receives neo-adjuvant treatment as the result of the Recurrence Score (RS) results from the core biopsy rather than proceeding directly to surgery. 3. Anxiety and depression symptoms measur

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Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026