Testing for Biomarkers

CAPItello-291 clinical trial

HR-positive, HER2-negative classification

The CAPItello-291 clinical trial included adults with locally advanced (inoperable) or metastatic HR-positive, HER2-negative breast cancer.

HER2-negative classification in the CAPItello-291 clinical trial: IHC 0 or IHC 1+ or IHC 2+/ISH-.

HER2=human epidermal growth factor receptor 2; HR=hormone receptor; IHC=immunohistochemistry; ISH=in situ hybridization.

PIK3CA/AKT1/PTEN-altered tumours

Patients with PIK3CA/AKT1/PTEN-altered tumours (n=289) represented 40.8% of the overall population.1*

Pie chart

40.8% Subgroup with PIK3CA/AKT1/PTEN-altered tumours

Gene alterations among the altered patients:

  • 76% PIK3CA,
  • 13% AKT1 and
  • 17% PTEN.1

Guideline recommendations

NCCN recommendations on biomarker testing associated with capivasertib + fulvestrant

* In adult patients with PIK3CA or AKT1 activating mutations, or for PTEN alterations after disease progression or recurrence after ≥1 prior lines of endocrine therapy, including one line containing a CDK4/6 inhibitor.

Breast cancer subtype
HR-positive/
HER2-negative
Biomarker
PIK3CA or AKT1 activating mutations or PTEN alterations
Detection
NGS (blood or tumour tissue if blood negative)
Agents
Capivasertib
+
fulvestrant
NCCN Category of evidence
Category 1
NCCN Category of preference
Preferred second-line therapy in select patients*

Adapted from the NCCN guidelines3
NGS=next-generation sequencing.

ASCO recommendations

ASCO recommends that choices be informed by prior treatments and by routine testing for activating mutations that include PIK3CA, or AKT1, or inactivation of PTEN.2

TEST for PIK3CA/AKT1/PTEN alterations

In patients who meet the following criteria:

HR-positive

HER2-negative

Have locally advanced OR metastatic breast cancer following progression on at least one endocrine-based regimen in the metastatic setting OR recurrence on or within 12 months of completing adjuvant therapy