The short term effects of an AKT inhibitor (AZD5363) on biomarkers of the AKT pathway and anti-tumour activity in a breast cancer paired biopsy study (STAKT trial) Sample Management Mr Kwok-Leung Cheung Clinical Associate Professor University of Nottingham STAKT Trial Co-investigator Alison McKendryProject Manager Quintiles

Sample management (1) Essentially a ‘paired biopsy study’ Many samples – a) Tumour tissues (FFPE +/- fresh frozen) b) Platelet rich plasma (PRP) c) Pharmacokinetic (PK) plasma d) Hair (eyebrow) Many laboratories

Sample management (2) Sponsor – University of Nottingham Central laboratory – Quintiles Other laboratories – a) Histopathology, Royal Derby Hospital b) Tenovus Institute, Cardiff c) University of Nottingham d) Other external laboratories

Sample management (3) – Pathway Central Lab (Quintiles) Site D Site C Site B Site A ICR Covance Tenovus Cardiff FFPE PK plasma Hair PRP Frozen tissue Nottingham Bank Serum Derby – Pathology review and sectioning

Sample management (4) All specimens (tumour and others) are sent to Quintiles as the central laboratory. Centralised tracking system of all specimens going in and out of Quintiles. A single manual on sample logistics covers the whole pathway and all procedures regardless of individual laboratory involvements.

Tumour sample management (1) 2 tumour blocks are to be sent, one from the diagnostic core biopsy and the second from the post-treatment core biopsy (can be obtained from the operative specimen). A standard validated FFPE protocol should be used – including taking multiple cores, immediate fixation in formalin, minimum fixation of 6 hrs, processing into one block to be sent etc.

Tumour sample management (2) Site  Quintiles central laboratory Quintiles central lab  Derby Histopathology (for pathology review and sectioning) Derby Histopathology  Cardiff (for biomarker measurements) Separate tracking between Derby and Cardiff

Management of other samples Site  Quintiles central laboratory  external labs as appropriate

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