The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.
Age ≥ 18
Male or female
cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)
FNA or core biopsy confirmed axillary nodal metastases at presentation
Bilateral synchronous invasive breast cancer
Sentinel node biopsy prior to NACT
Previous axillary nodal surgery on the same body side as the scheduled targeted sampling
Any previous cancer within last 5 years or concomitant malignancy except
Parallel
Axillary lymph node dissection
Procedure/SurgeryParticipants will undergo removal of at least level I and II axillary lymph nodes.
Axillary radiotherapy
RadiationAxillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Breast or chest wall radiotherapy
RadiationBreast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Disease free survival (DFS)
DFS calculated as the time from randomisation until the date of 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.
Patient reported lymphoedema
Lymphoedema is self-reported based on two items from the validated Lymphoedema and Breast Cancer Questionnaire (arm "swelling now" and arm "heaviness in the past year"). Lymphoedema is defined as 'yes' to both questions.
Arm function
Arm function will be assessed using shortened version of the Disability of the Arm, Shoulder and Hand (DASH), the 11-item QuickDASH questionnaire. Physical disability is defined as a change from baseline in the QuickDASH score of at least 14 points.
Health related quality of life: EQ-5D-5L
Health related quality of life will be assessed with EQ-5D-5L
Axillary recurrence free interval
Axillary recurrence free interval, calculated from the date of randomisation to the date of axillary recurrence or the censor date.
Overall survival
Overall survival calculated as the time from randomisation until the date of death by any cause or the censor date.
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