The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Atirmociclib (PF-07220060) is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Japan
EXPERIMENTAL: Arm A
PF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
DRUG: PF-07220060
CDK4 inhibitor
DRUG: letrozole
endocrine therapy
ACTIVE_COMPARATOR: Arm B
Investigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
DRUG: letrozole
endocrine therapy
DRUG: abemaciclib
CDK4/6 inhibitor
DRUG: palbociclib
CDK4/6 inhibitor
DRUG: ribociclib
CDK4/6 inhibitor
Progression Free Survival (PFS) by BICR
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first
From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause
From the date of randomization until death due to any cause (up to approximately 13 years).
Progression Free Survival (PFS) by Investigator
Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first
From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)
OR by BICR and by investigator
Time from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first
From randomization to progression or death whichever occurs first (up to approximately 4 years)
Duration of Response (DoR) by BICR and by investigator
Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first
From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years)
Incidence of treatment emergent treatment relatedadverse events (AE)
Incidence and severity of AEs graded according to the NCI CTCAE v5.0
Duration of the study approximately up to 13 years.
Incidence of treatment emergent treatment relatedserious adverse events
Incidence and severity of AEs graded according to NCI CTCAE v5.0
Duration of the study approximately up to 13 years.
Estimated mean change from baseline in EORTC QLQ C30
Baseline to end of treatment (up to approximately 4 years)
Estimated mean change from baseline in BPI-SF
Baseline to end of treatment (up to approximately 4 years)
Estimated mean change from baseline in EQ-5D-5L
Baseline to end of treatment (up to approximately 4 years)
Estimated mean change from baseline in EORTC Breast Cancer Module (BR42)
Baseline to end of treatment (up to approximately 4 years)
Mean change from baseline of ctDNA
Baseline to end of treatment (up to approximately 4 years)
1020
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT06760637
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