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CAPItello-291

Capivasertib in hormone receptor-positive advanced breast cancer

Phase 3N = 708NCT04305496

Population
Pre-, peri- and postmenopausal women and men with HR-positive, HER2-negative advanced breast cancer relapsing or progressing during or after an aromatase inhibitor, with or without a prior CDK4/6 inhibitor; 289 (40.8%) had AKT pathway alterations (PIK3CA, AKT1 or PTEN)
Design
Phase 3, randomized, double-blind trial (1:1) of capivasertib plus fulvestrant versus placebo plus fulvestrant; dual primary endpoint of investigator-assessed PFS in the overall population and in the AKT pathway-altered population
Primary endpoint
PFS
Arms
  • Capivasertib plus fulvestrant (experimental): Capivasertib plus fulvestrant
  • Placebo plus fulvestrant (control): Placebo plus fulvestrant
People
Turner NC, CAPItello-291 Study Group
PFSHR 0.60 (95% CI 0.51–0.71)Δ median PFS+3.6 monthsPFSHR 0.50 (95% CI 0.38–0.65)Δ median PFS+4.2 months
Show the numbers
Results reported for CAPItello-291
EndpointAnalysisCapivasertib plus fulvestrantPlacebo plus fulvestrantEffect
PFSprimaryTurner 2023median 7.2 monthsmedian 3.6 monthsHR 0.60 (95% CI 0.51–0.71)P<0.001
PFSAKT pathway-altered (PIK3CA, AKT1 or PTEN) tumours (n=289)primaryTurner 2023median 7.3 monthsmedian 3.1 monthsHR 0.50 (95% CI 0.38–0.65)P<0.001
Results reported for CAPItello-291
EndpointAnalysisCapivasertib plus fulvestrantPlacebo plus fulvestrantEffect
PFSprimaryTurner 2023median 7.2 monthsmedian 3.6 monthsHR 0.60 (95% CI 0.51–0.71)P<0.001
PFSAKT pathway-altered (PIK3CA, AKT1 or PTEN) tumours (n=289)primaryTurner 2023median 7.3 monthsmedian 3.1 monthsHR 0.50 (95% CI 0.38–0.65)P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.60.51–0.71
PFS0.50.38–0.65
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Capivasertib plus fulvestrant (experimental)
  • Placebo plus fulvestrant (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCapivasertib plus fulvestrantPlacebo plus fulvestrant
0100.0%100.0%
561.8%38.2%
942.0%17.7%
1426.0%6.8%
1817.7%3.1%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Capivasertib plus fulvestrant (experimental)
  • Placebo plus fulvestrant (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCapivasertib plus fulvestrantPlacebo plus fulvestrant
0100.0%100.0%
562.2%32.7%
942.5%13.4%
1426.5%4.4%
1818.1%1.8%
Primary publication: Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, et al. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023;388(22):2058-2070. PubMedDOI

Appears in

Sources

  1. Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, et al. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023;388(22):2058-2070.

    PubMedDOI