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Co-primary outcomes, collected annually for 5 years:
Disease-Free Survival (DFS); defined and calculated as the time from randomisation until the date of the first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date
Lymphoedema: self-reported based on two items from the validated Lymphoedema and Breast Cancer Questionnaire (LBCQ) (arm “swelling now” and arm “heaviness in the past year”). Lymphoedema will be defined as ‘yes’ to both questions at 5 years.
Collected annually for 5 years:
Arm function assessed using the shortened version of the Disability of the Arm, Shoulder and Hand (DASH), the 11-item QuickDASH questionnaire, over 5 years
Pain intensity and characteristics measured using questions from the Douleur Neuropathique (DN4) and Pain Numeric Rating Scale (NRS) and will relate to the areas affected by surgery and cancer treatment, over 5 years
Axillary recurrence-free interval, calculated from the date of randomisation to the date of axillary recurrence or the censor date. Axillary recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site. The date of axillary recurrence is the date on which imaging or pathology report (whichever comes first) confirms axillary recurrence. Axillary recurrence will be compared between the two allocated groups over 5 years
Overall survival; calculated as the time from randomisation until the date of death by any cause or the censor date. Overall survival will be compared between the two allocated groups over 5 years
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. The date of local recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence. Local recurrence will be compared between the two allocated groups over 5 years
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of regional recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence. Regional (nodal) recurrence will be compared between the two allocated groups over 5 years
Distant metastasis is defined as confirmed metastasis (positive pathology and/or definitive evidence on imaging) in all other sites of recurrence and may include those classified as: soft-tissue category, visceral category, central nervous system and skeletal spread. The date of distant metastasis is the date on which the imaging or pathology report (whichever comes first) confirms metastasis. Distant metastases will be compared between the two allocated groups over 5 years.
Contralateral breast cancer is defined as a new primary malignancy in the opposite breast unless obviously contiguous with recurrent chest wall disease or proven on cytology/biopsy to be of metastatic origin. Contralateral breast cancers will be compared between the two allocated groups over 5 years.
Non-breast cancer is defined as any new non-breast primary malignancy, except for basal or squamous cell cancer of the skin, in situ carcinoma of the cervix, or in situ or stage 1 melanoma. New breast cancers will be compared between the two allocated groups over 5 years.
Economic evaluation (data to be collected annually, over 5 years, through annual follow-up and patient questionnaires):
Costs to the NHS and participants will be compared between the two allocated groups over 5 years
Quality-adjusted life years (QALYs) will be compared between the two groups over 5 years. QALYs based on responses to the EQ-5D-5L administered at baseline, 12, 24, 36, 48, and 60 months post-randomisation
Incremental cost per disease-free interval over 5 years
Incremental cost per lymphoedema avoided over 5 years
Incremental cost per QALY gained over 5 years
Incremental cost per QALY over the estimated lifetime of a participant with early-stage breast cancer