Breast cancer Cancer Breast
Conditions
Interventions
Patients are randomised to receive either the standard triple assessment (mammography, ultrasound, core biopsy/fine needle aspiration [FNA]) or standard triple assessment plus an MR scan.
multifocal lesions present or tumour size greater on MRI - surgical management reviewed
or MC disease detected. If MC lesions are 5mm MR-localised, US-guided FNAC/ core biopsy required. Biopsy -ve patients will proceed to WLE, but if +ve surgical management will be reviewed. Repeat MRI o
Sponsors
Hull and East Yorkshire Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients scheduled for wide local excision for primary breast cancer
Exclusion criteria
Exclusion criteria: Added as of 10/06/2008: 1. Medically unstable 2. Known contraindication to magnetic resonance (MR) scanning 3. Known to have had an allergic reaction associated with previous administration of paramagnetic contrast agent or have a severe allergic diathesis 4. Require renal dialysis 5. Have undergone chemotherapy/ hormonal therapy for cancer of the contralateral breast (or other sites) in the previous 12 months or have chemotherapy planned to any site before their breast surgery 6. Have had surgery or radiotherapy for cancer to the ipsilateral breast 7. Have had surgery to the ipsilateral breast within the previous 4 months for benign breast disease 8. Have a history of serious breast trauma within the last 3 months 9. Pregnant or breast feeding 10. Disability preventing MR scanning in the prone position 11. Under the care of a breast surgeon recruiting into the ALMANAC Trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost and outcome measures: 1. Comparison of re-operation/ mastectomy/RTX rates after TA or TA and MRI. 2. IBTR rate at 5 yrs for patients imaged ñ MRI. 3. Extrapolated life expectancy and quality adjusted life expectancy. 4. Quantification of patient satisfaction with management decisions and quality of life measurements using FACT-B, HADS score, EQ-5D and ad-hoc questionnaire to examine concerns about tumour recurrence. 5. Differential resource implications in first year of TA vs TA + MRI, including measurement of indirect and personal costs incurred by patients. 6. Estimation of later costs due to differential rates of recurrence related to life expectancy and quality adjusted life expectancy. 7. Determination of sub-groups most likely to benefit from addition of DCE-MRI. 8. Effectiveness of XRM, US and DCE-MRI imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 10/06/2008: 1. Recurrence rate 2. Chemotherapy/radiotherapy interventions 3. Quality of life and patient satisfaction 4. Risk factors for referral for MR imaging 5. Effectiveness of imaging 6. Change in clinical management 7. Clinical significance of <5 mm MR-only detected lesions | — |
Countries
England, United Kingdom
Outcome results
None listed