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, Argentina, Australia, Brazil, Canada, Chile, China, India, Israel, Japan, Korea, Republic of, Mexico, Switzerland, Taiwan, Turkey, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Arm A
PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
DRUG: PF-07220060 CDK4 inhibitor
ExperimentalDRUG: Fulvestrant
Experimental and Active comparatorACTIVE_COMPARATOR: Arm B
Investigator's choice of therapy of either: * Fulvestrant alone (a solution for injection), or * Everolimus in combination with exemestane, both a tablet to be taken by mouth.
DRUG: Fulvestrant
Experimental and Active comparatorDRUG: Everolimus
Active ComparatorDRUG: Exemestane
Active ComparatorProgression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
From Initiation up to 2 years
Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause up to approximately 5 years
PFS as defined by investigator
Time from the date of randomization up to approximately 2 years
OR by BICR and by investigator per RECIST v1.1
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 (up to approximately 2 years)
Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1
From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by BICR and by investigator per RECIST v1.1
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years
Number or Patients with Adverse Events (AEs) by Type
From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Incidence
From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Seriousness
From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by relationship to study interventions
From screening until 28 days after the last dose, to approximately 3 years
Number of Participants With Abnormal Electrocardiogram (ECG)
From baseline to approximately 2 years
Number of Participants With Laboratory Test Abnormalities
From screening until 28 days after the last dose to approximately 2 years
EQ-5D-5L
Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days
EORTC QLQ
Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days
EORTC QLQ Breast Cancer Module 23 (BR23)
Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days
Ctrough of PF-07220060
Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
500
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.
NCT06105632
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