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

Not Applicable

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN14337451
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38489298/ (added 18/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-16
• Study Completion: 2023-11-23
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 341

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.
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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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified