Adults diagnosed with primary T1-2 breast cancer, with low nodal disease Cancer
Conditions
Interventions
The TADPOLE trial is a multi-centre, parallel group, pragmatic phase 3 randomised controlled trial with a 9-month internal pilot phase, embedded qualitative research, surgical and radiotherapy quality
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ALL of the following must apply: 1. Adults (> = 18 years of age) 2. Primary T1-2 breast cancer of any grade (multifocal/multicentric disease is permitted) 3. Low volume N1 axillary nodal disease confirmed on core biopsy or fine needle aspiration cytology, defined as: 3.1. Clinically normal (cN0) 3.2. Radiologically detected nodal involvement 3.3. With < = 2 involved nodes on USS 4. Able and willing to provide written informed consent 5. Willing, fit and able to undergo primary surgical treatment
Exclusion criteria
Exclusion criteria: Participants may not enter the study if ANY of the following apply: 1. > = 3 suspicious nodes on USS or clinically abnormal nodes (cN1) 2. T3 or T4 disease by clinical or radiological assessment 3. Pure invasive lobular carcinoma 4. Bilateral breast cancer 5. Previous ipsilateral breast cancer or ductal carcinoma in situ 6. Received neoadjuvant systemic anticancer therapy (neoSACT) 7. Received neoadjuvant endocrine therapy (defined as > 4 weeks of treatment) 8. Previous axillary surgery (sentinel node biopsy, axillary node clearance or axillary sample) 9. Other invasive cancers unless: 9.1. Disease-free for 5 years or 9.2. Previous basal cell carcinoma, cervical carcinoma in situ, non-muscle invasive urothelial carcinoma 10. High-risk group for developing breast cancer as defined by NICE guidance 11. Pregnant or breastfeeding 12. Any serious and/or unstable pre-existing medical, psychiatric or other condition that would prevent compliance with the trial or consent process 13. Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following co-primary outcome measures will be assessed: 1. Lymphoedema at 12 months post-surgery, defined as BOTH an objective increase in arm circumference of >2cm from baseline, and using two items from the validated Lymphoedema and Breast Cancer Questionnaire (LBCQ) for patients to self-report lymphoedema symptoms defined as a response of ‘yes’ to both: arm “swelling now” and arm “heaviness in the past year” from. A composite endpoint combining objective and patient-reported outcomes was considered important to minimise potential bias in the trial. 2. Locoregional recurrence (LRR) at 5 years, defined as pathologically and/or radiologically confirmed recurrent tumour in the ipsilateral breast after breast conserving surgery or the skin or soft tissues of the chest wall within the anatomical boundaries of the breast after mastectomy; ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of locoregional recurrence will be the date on the imaging or pathology report, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be collected (all timepoints are measured from post-last axillary surgery): 1. Surgical complications measured using data collected from the electronic case report form (eCRF) at 1-month post-surgery 2. Surgical and oncological outcomes measured using data collected from patient medical records at 1-month post-surgery 3. Patient-reported lymphoedema assessed using two questions from the LBCQ questionnaire (as per primary outcome) at 12, 24 and 60 months 4. Objective assessment of lymphoedema using measurement of arm circumference at 12 months 5. Arm and shoulder morbidity measured using the QuickDASH questionnaire at 12, 24 and 60 months 6. Pain measured using the Numerical Pain Rating Scale (NPRS) at 1 and 12 months 7. Overall and disease-free survival measured using data collected from patient medical records at 60 months 8. Health-related quality of life measured using the EQ-5D-5L, FACT-B+4 and LYMPH-Q at 12, 24, and 60 months 9. Resource use to estimate costs measured using the ModRUM questionnaire and data collected from the patient’s medical records at 12, 24, 60 months and modelled beyond the end of the trial | — |
Countries
England, United Kingdom
Contacts
Public ContactLucy Dabner
Outcome results
None listed