- Patients must have a minimum of five, available unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node
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- (these will be submitted to a central laboratory to determine PD-L1 expression)
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- the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide
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- local PD-L1 results, even if available, will not substitute for central testing
NOTE: Initial order for specimen kits should be placed at least two weeks prior to registering the first patient at each site
Patients must be offered the opportunity to participate in specimen banking
The BAHO substudy was permanently closed to accrual on June 23, 2020, and willingness of English-speaking patients to participate in the BAHO substudy is no longer applicable
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