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Impact of AKT Inhibitor AZD5363 on Biomarkers and Tumor Activity in Breast Cancer: STAKT Study Insights

The STAKT trial explores the short-term effects of the AKT inhibitor AZD5363 on breast cancer biomarkers and tumor activity through a paired biopsy study. Involving numerous samples such as tumor tissues, platelet-rich plasma (PRP), pharmacokinetic plasma, and eyebrow hair, the management of these specimens is crucial for the trial's success. The University of Nottingham sponsors the study, with Quintiles as the central laboratory, ensuring a centralized tracking system and standardized protocols for specimen handling across multiple laboratories.

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Impact of AKT Inhibitor AZD5363 on Biomarkers and Tumor Activity in Breast Cancer: STAKT Study Insights

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  1. 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 McKendry Project Manager Quintiles

  2. 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

  3. 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

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

  5. 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.

  6. 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.

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

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

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