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AKT pathway testing in the NHS

Actionable biomarkers within the PI3K/AKT pathway can be identified in ~50% of patients with HR+/HER2-negative aBC.1

 

 

Adaptive changes along the PI3K/AKT pathway can drive treatment resistance and disease progression in patients with

HR+/HER2-negative aBC.1,2

 

TRUQAP (capivasertib) plus fulvestrant is a targeted therapy that uses AKT inhibition and ER downregulation to address this treatment resistance.1

 

To maximise your chances of detecting AKT pathway alterations, utilise both tissue-based testing at diagnosis and ctDNA-based testing at disease progression.3

 

Key genetic alterationsConsequence
Point mutations of PIK3CA4Hyperactivation of PI3K
Point mutations of AKT15Constitutive signal activation of AKT
Point mutations, large deletions and
genomic rearrangements involving PTEN6		Loss of function of PTEN

​

Biomarker testing for patients with HR+/HER2-negative aBC is vital to ensure actionable biomarkers are identified at the time of diagnosis and reported to help inform appropriate treatment decisions.7

All genetic tests carried out in the UK are provided by a network of Genomic Laboratory Hubs.8 The tests available for patients with breast cancer are outlined in the National Genomic Test Directory for Cancer (this external link is not owned by AstraZeneca), which provides testing information with

respect to:9

The National Genomic Test Directory for Cancer is updated each year to ensure healthcare professionals have access to the latest diagnostics and treatments for patients.9

 

Most tests for breast cancer genomic analysis in the UK utilise NGS panel testing, which is a high-throughput approach to DNA sequencing using the concept of mass parallel processing.10 Employing this technique for your patients with HR+/HER2-negative aBC can help to provide a comprehensive profile of potential alterations in the PI3K/AKT pathway.11

Tissue testing

Test at aBC diagnosis with M3.6 test code using tissue biopsy9

Test code M3.6 utilises a tissue-based, multi-target NGS panel to detect small variants and CNVs, providing a molecular level assessment of the PIK3CA/ATK1/PTEN genes to aid diagnosis and management of breast cancer.
Archival tissue: if diagnostic biopsy tissue is unavailable, archival tissue (such as from primary tumour resection) may be used instead.12

ctDNA testing

Test at disease progression with M3.13 test code using ctDNA
liquid biopsy9

Test code M3.13 utilises a ctDNA-based, multi-target NGS panel to detect small variants and CNVs in 
PIK3CA/AKT1/PTEN genes to aid treatment decisions in patients with HR+/HER2-negative locally advanced or metastatic breast cancer that has progressed on 1L endocrine treatment.*

*Aromatase inhibitor plus CDK4/6 inhibitor.

It is important to first look back at previous NGS reports and consult with your genomic testing provider to see if further information on PIK3CA/AKT1/PTEN status can be made available from the original test.
If you have identified one or more PIK3CA/AKT1/PTEN alterations, your patient may be eligible for treatment with TRUQAP plus fulvestrant.
Learn more about the efficacy of TRUQAP plus fulvestrant

Resources for you and
your patients

Learn more about genomic testing in our comprehensive

resources and explore materials designed to support

your patients throughout the treatment journey with

TRUQAP plus fulvestrant.

Explore resources

1L=first-line; aBC=advanced breast cancer; AKT=serine/threonine protein kinase; AKT1=serine/threonine protein kinase 1; CDK4/6=cyclin-dependent kinase 4/6; CNV=copy number variation; ctDNA=circulating tumour DNA; DNA=deoxyribonucleic acid; ER=oestrogen receptor; HER2=human epidermal growth factor receptor 2; HR+=hormone receptor positive; NGS=next-generation sequencing; NHS=National Health Service; PI3K=phosphatidylinositol-3 kinase; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PTEN=phosphatase and tensin homologue.

  1. Turner NC, et al. N Engl J Med. 2023;388(22):2058–2070.
  2. Papadimitriou MC, et al. Biochim Biophys Acta Mol Cell Res. 2022;1869(12):119346.
  3. Pascual J, et al. Ann Oncol. 2022;33(8):750–68.
  4. Miricescu D, et al. Int J Mol Sci. 2020;22(1):173.
  5. Smyth LM, et al. Cancer Discov. 2020;10(4):526–535.
  6. Chen J, et al. Front Oncol. 2022;12:825484.
  7. Schmid S, et al. Esmo Open. 2022;7(5):100570.
  8. NHS Genomic Medicine Service. Available at: https://www.england.nhs.uk/genomics/nhs-genomic-med-service/. Accessed April 2026.
  9. National Genomic Test Directory. Available at: https://www.england.nhs.uk/publication/national-genomic-test-directories/. Accessed April 2026.
  10. Behjati S and Tarpey PS. Arch Dis Child Educ Pract Ed. 2013;98(6):236–238.
  11. Venetis K, et al. Cells. 2022;11(22)3545. 
  12. Wales Cancer Network. Available at: executive.nhs.wales/functions/networks-and-planning/cancer/wcn-documents/mutated-breast-cancer-clinical-guidance-document/. Accessed April 2026.
  13. Turner NC, et al. Presented at: San Antonio Breast Cancer Symposium (SABCS); 9–12 December 2025; San Antonio, TX, USA. Oral presentation GS3-10.

GB-68389 | April 2026

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