1604 - PIK3CA mutation testing for postmenopausal women or men with advanced breast cancer who have progressed during or following treatment with an aromatase inhibitor

Page last updated: 28 July 2020

Application Detail

Description of Medical Service

The phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) pathway is postulated to be a central oncogenic pathway that regulates cell proliferation, cell metabolism, growth, survival, and apoptosis. Changes in PI3K activity are associated with resistance to endocrine, chemo-, radio-, and anti-HER2 therapies. Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutations are reported in up to 45% of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancers.

Testing for PIK3CA mutations can be performed on either tissue or plasma samples. Testing for PIK3CA mutation would be preferentially performed using fresh tissue, biopsied at the site of local recurrence or metastasis, but archival tissue could be used instead. The biopsy would typically be performed, and testing requested, by a surgeon or oncologist.

Description of Medical Condition

Approximately 60-70% of breast tumours are HR+/HER2-. While endocrine therapy is the treatment of choice for subjects with HR+ advanced breast cancer, progressive disease ultimately develops in all subjects, either due to primary resistance or relapse/progression following an initial response. Two new classes of targeted compounds (mTOR inhibitors, and cyclin-dependent kinase 4/6 inhibitors) are believed to be effective when combined with endocrine therapy. However, to date no predictive biomarkers have been identified to select patients that would benefit the most from these therapies.

Reason for Application

New MBS item

Medical Service Type

Co-dependent therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1233 KB)
Application Form (Word 171 KB)

Consultation Survey

Consultation Survey (PDF 489 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1706 KB)
PICO Confirmation (Word 301 KB)

Assessment Report


Public Summary Document


Meetings for this Application


5-6 December 2019