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A Phase III, open-label, randomized study of camizestrant + capivasertib vs. physicians' choice of ET in patients with HR+/HER2- mBC whose disease has progressed after one line of ET+CDK4/6i in the advanced setting
Primary
To demonstrate the superiority of camizestrant + capivasertib relative to physician s choice of ET by assessment of PFS in the overall study population and/or
a subpopulation of patients with breast cancers harboring PIK3CA/AKT1/PTEN-alteration(s)1 and/or
a subpopulation of patients with breast cancers not harboring a PIK3CA/AKT1/PTEN-alteration1 and/or
a subpopulation of patients with breast cancers harboring ESR1m1
Secondary
To demonstrate superiority of camizestrant + capivasertib relative to physician s choice of ET by assessment of overall survival (OS) in:
the overall study population and/or
a subpopulation of patients with breast cancers harboring PIK3CA/AKT1/PTEN-alteration(s) and/or
a subpopulation of patients with breast cancers not harboring a PIK3CA/AKT1/PTEN-alteration and/or
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of objective response rate (ORR) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of duration of response (DoR) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of clinical benefit rate (CBR) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of second progression free survival (PFS2) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To evaluate the PK of camizestrant in combination with capivasertib in all participants who receive at least one dose of camizestrant per the protocol, for whom there are at least one reportable PK concentration.
To evaluate the PK of capivasertib in combination with camizestrant in all participants who receive at least one dose of capivasertib per the protocol, for whom there are at least one reportable PK concentration.
To assess participant-reported physical function, global health status/quality of life (GHS/QoL), and pain in participants treated with camizestrant + capivasertib relative to physician s choice of ET in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
Safety
To assess the safety and tolerability of camizestrant + capivasertib relative to physician s choice of ET in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
Primary
To demonstrate the superiority of camizestrant + capivasertib relative to physician s choice of ET by assessment of PFS in the overall study population and/or
a subpopulation of patients with breast cancers harboring PIK3CA/AKT1/PTEN-alteration(s)1 and/or
a subpopulation of patients with breast cancers not harboring a PIK3CA/AKT1/PTEN-alteration1 and/or
a subpopulation of patients with breast cancers harboring ESR1m1
Secondary
To demonstrate superiority of camizestrant + capivasertib relative to physician s choice of ET by assessment of overall survival (OS) in:
the overall study population and/or
a subpopulation of patients with breast cancers harboring PIK3CA/AKT1/PTEN-alteration(s) and/or
a subpopulation of patients with breast cancers not harboring a PIK3CA/AKT1/PTEN-alteration and/or
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of objective response rate (ORR) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of duration of response (DoR) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of clinical benefit rate (CBR) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To estimate the effectiveness of camizestrant + capivasertib relative to physician s choice of ET by assessment of second progression free survival (PFS2) in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
To evaluate the PK of camizestrant in combination with capivasertib in all participants who receive at least one dose of camizestrant per the protocol, for whom there are at least one reportable PK concentration.
To evaluate the PK of capivasertib in combination with camizestrant in all participants who receive at least one dose of capivasertib per the protocol, for whom there are at least one reportable PK concentration.
To assess participant-reported physical function, global health status/quality of life (GHS/QoL), and pain in participants treated with camizestrant + capivasertib relative to physician s choice of ET in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
Safety
To assess the safety and tolerability of camizestrant + capivasertib relative to physician s choice of ET in:
the overall study population
a subpopulation of patients with breast cancer harboring PIK3CA/AKT1/PTEN-alteration(s)
a subpopulation of patients with breast cancer not harboring a PIK3CA/AKT1/PTEN-alteration
a subpopulation of patients with breast cancers harboring ESR1m
Recruitment Status
Coming Soon