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PF-07220060 CDK4 inhibitor

Phase 2

Advanced or Metastatic Breast Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 20, 2026

Target and mechanism

Target class-Ciclib (Cdk)
ModalitySmall molecule

Also known as PF-07220060, Atirmociclib

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment333

FDA Designations

No designations recorded

Clinical trial landscape

PF-07220060 CDK4 inhibitor · 1 trial · 1 indication

Phase 2 1
NCT06105632A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of TreatmentAdvanced or Metastatic Breast Cancer
ACTIVE NOT_RECRUITING333 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
Advanced or Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
From Initiation up to 2 years

Secondary Endpoints

Overall Survival (OS)
Time from the date of randomization to the date of death due to any cause up to approximately 3 years
OR 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 defined 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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALPF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
Arm BACTIVE_COMPARATORInvestigator'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.

Interventions

NameTypeDescription
PF-07220060 CDK4 inhibitorDRUGExperimental
FulvestrantDRUGExperimental and Active comparator
EverolimusDRUGActive Comparator
ExemestaneDRUGActive Comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. * Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor * Do...

Countries:United StatesArgentinaAustraliaBrazilCanadaChinaIndiaIsraelJapanMexicoSouth KoreaTaiwanTurkey (Türkiye)United Kingdom
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Competitive Landscape -Breast Cancer 402 trials (matched to "Advanced or Metastatic Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT06105632lastUpdatePostDate: changed
LOWAug 20, 2026NCT06105632lastUpdatePostDate: changed

Frequently asked questions about PF-07220060 CDK4 inhibitor

What is Atirmociclib used for?

Atirmociclib is an investigational small molecule being studied for use in advanced or metastatic breast cancer, liposarcoma, prostate cancer, and adenocarcinoma of the lung. It is also being evaluated in healthy participants for drug interaction studies. Atirmociclib is not yet approved and remains in clinical development.

What does Atirmociclib target?

Atirmociclib is a CDK inhibitor, belonging to the -ciclib class of drugs that target cyclin-dependent kinases. It is being studied for its potential role in treating certain cancers by interfering with cell cycle progression.

Who makes Atirmociclib?

Atirmociclib is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is Atirmociclib in?

Atirmociclib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and potential efficacy in various cancer types.

What clinical trials is Atirmociclib in?

Atirmociclib is being studied in several clinical trials, including NCT04557449 in advanced solid tumors, NCT06465368 in postmenopausal breast cancer, NCT06760637 in HR-positive HER2-negative breast cancer, and NCT06897683 in healthy adults. These trials are at various stages and are conducted internationally.

Is Atirmociclib the same as PF-07220060?

Yes, Atirmociclib is also known as PF-07220060. The drug is referred to by this alternative name in clinical trial registries and scientific literature. It is also sometimes listed with combination partners such as PF-07104091 in certain study contexts.