A feasibility study comparing the safety and acceptability of vacuum-assisted biopsy and conventional 14-gauge core biopsy in the diagnosis of ultrasonically indeterminate and abnormal axillary lymph nodes

INTERVENTION: Participants randomised to have axillary lymph node biopsy with either 14‐gauge core needle biopsy device or a 13‐gauge or 10‐gauge vacuum biopsy device. Study Entry : Registration only CONDITION: Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast ; Cancer PRIMARY OUTCOME: Proportion of women who would be willing to undergo the biopsy again.; Timepoint(s): 4 to 14 days post‐biopsy SECONDARY OUTCOME: 1. Procedure pain scores; Timepoint(s): Immediate and at 4‐14 days post‐biopsy; 2. Proportion of women approached who are willing to enter the study.; Timepoint(s): AT recruitment; 3. The sensitivity of vacuum biopsy relative to conventional core biopsy (preliminary data only); Timepoint(s): Following surgery INCLUSION CRITERIA: 1. Women in screening and symptomatic clinics aged >35 years with breast masses scored as: 1.1. M4 or M5 (mammographically suspicious or highly suspicious of malignancy) and U5 (ultrasonically highly suspicious of malignancy) 1.2. and/or MRI5 (highly suspicious of malignancy on MRI) and U5 1.3. and/or have histologically proven breast cancer 1.4. and who have ultrasonically indeterminate or abnormal ipsilateral axillary lymph nodes (i.e. suspicious of metastatic disease) 2. Indeterminate / abnormal lymph nodes are defined as those with >2.3mm lymphoid thickness and/or focal cortical bulging and/or non‐hilar blood flow and/or loss or reduction in the normal hilar fat