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Testing for Biomarkers

CAPItello-291 clinical trial
— HR-positive, HER2-negative classification
— PIK3CA/AKT1/PTEN-altered tumours
Guideline recommendations

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*

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^w inactivating mutations and genomic changes (e.g. deletion)

Detection

NGS, PCR

Agents

Capivasertib
+
fulvestrant

NCCN Category of evidence

Category 1

NCCN Category of preference

Preferred (For disease progression during or after a prior line of aromatase inhibitor plus CDK 4/6 inhibitor therapy in the adjuvant or metastatic setting)

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

Learn more about the efficacy profile of TRUQAP

Important safety information for TRUQAP®