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Discover TRUQAP

in the treatment of HR-positive, HER2-negative metastatic breast cancer with PIK3CA/AKT1/PTEN activating mutations
Learn more about efficacy data from the pivotal CAPItello-291 trial

In HR-positive, HER2-negative metastatic breast cancer:

TEST for PIK3CA/AKT1/PTEN alterations

CONSIDER TREATING with TRUQAP + fulvestrant1

TRUQAP (capivasertib tablets), in combination with fulvestrant, is indicated for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.1

AKT1=serine/threonine protein kinase 1; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PTEN=phosphatase and tensin homolog.

Demonstrated efficacy and tolerability profile

CAPItello-291 trial: in patients with PIK3CA/AKT1/PTEN alterations, TRUQAP + fulvestrant demonstrated:1*

50% reduction HR=0.50† (95% CI:
0.38, 0.65; p<0.001‡)
in risk of progression or death with TRUQAP + fulvestrant vs. fulvestrant HR=0.50† (95% CI:
0.38, 0.65; p<0.001‡) Number of events (%): TRUQAP + fulvestrant 121 (78.1) vs. fulvestrant 115 (85.8)
  • Median PFS: 7.3 months (95% CI: 5.5, 9.0) vs. 3.1 months (95% CI: 2.0, 3.7) with fulvestrant
10.4% of TRUQAP + fulvestrant patients discontinued due to adverse reactions.

Explore the efficacy profile of TRUQAP + fulvestrant

Guideline recommendations for capivasertib + fulvestrant

ASCO Capivasertib + fulvestrant is a second-line treatment option for HR-positive, HER2-negative metastatic breast cancer appropriate for tumours harboring PIK3CA or AKT1 mutations or PTEN inactivation.2

NCCN
Category 1 recommendation: Capivasertib + fulvestrant is a preferred regimen in 2L for HR-positive, HER2-negative metastatic breast cancer in adult patients with PIK3CA/AKT1/PTEN activating mutations after disease progression or recurrence after one or more prior lines of ET, including one line containing a CDK4/6 inhibitor.3§

2L=second-line; ET=endocrine therapy; CDK4/6=cyclin-dependent kinase 4 and 6; NCCN=National Comprehensive Cancer Network.
§ For complete recommendations, please see NCCN guidelines.

PFS=progression-free survival.

* In CAPItello-291, a total of 708 patients were randomized 1:1 to receive either 400 mg of TRUQAP (N=355) or placebo (N=353) given twice daily for 4 days followed by 3 days off treatment each week of a 28-day treatment cycle. Fulvestrant 500 mg was administered on Cycle 1 Days 1 and 15 and then at Day 1 of a 28-day cycle. In total, 289 patients had tumours with eligible PIK3CA/AKT1/PTEN alterations. A primary endpoint was investigator-assessed PFS in the subgroup with PIK3CA/AKT1/PTEN-altered tumours.

† Stratified Cox proportional hazards model. A hazard ratio <1 favours capivasertib + fulvestrant.

‡ Stratified log-rank test.

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