Recent Updates
Recently added Catalysts

PF-07220060

Phase 3

Breast Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,156
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06760637Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic DiseasePHASE3 ACTIVE NOT_RECRUITING 1,035Jan 6, 2025Dec 29, 2037May 19, 2026463 United States, Argentina +28
NCT06465368A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post MenopausePHASE2 COMPLETED 121Jul 11, 2024Jul 10, 2025Oct 1, 202551 United States, Australia +11
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Progression Free Survival (PFS) by BICR
From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)

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

Rate of Ki-67
Day 14

Centrally assessed biopsy

Secondary Endpoints
Overall Survival (OS)
From the date of randomization until death due to any cause (up to approximately 13 years).
Progression Free Survival (PFS) by Investigator
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
From randomization to progression or death whichever occurs first (up to approximately 4 years)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALPF-07220060 tablet taken by mouth plus Letrozole tablet taken by mouth
Arm BACTIVE_COMPARATORInvestigator's Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth
Arm A/Experimental/PF-07220060 plus letrozoleEXPERIMENTALPF-07220060 given as tablet by mouth twice a day for 14 days. Letrozole given as tablet by mouth once a day for 14 days.
Arm B/Control/letrozoleACTIVE_COMPARATORLetrozole given by mouth once a day for 14 days.
Interventions
NameTypeDescription
PF-07220060DRUGCDK4 inhibitor
letrozoleDRUGendocrine therapy
abemaciclibDRUGCDK4/6 inhibitor
palbociclibDRUGCDK4/6 inhibitor
ribociclibDRUGCDK4/6 inhibitor
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites463

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 * Doc...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChinaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIndiaIrelandIsraelItalyJapanNetherlandsPolandSlovakiaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
Unlock Eligibility Criteria
Competitive Landscape -Breast Cancer 408 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib, Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy, Imlunestrant, Tamoxifen, Anastrozole
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1, Capecitabine, Paclitaxel, Nab-paclitaxel
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib, Alpelisib, Fulvestrant, Trastuzumab, Pertuzumab
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant, PF-07220060, letrozole, abemaciclib
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib, Arm A: Gedatolisib + Palbociclib + Fulvestrant
Relay Therapeutics, Inc.RLAY2PHASE3RLY-2608, Capivasertib, Fulvestrant, Palbociclib, Ribociclib
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, Pembrolizumab, Axatilimab
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam, Alisertib, Endocrine therapy
Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06760637Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06760637studyFirstPostDate: changed