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Palbociclib

Phase 2

Female Breast Carcinoma | Small molecule | Oncology |Atrium Therapeutics, Inc.|Last Updated: May 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02942355Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast CancerPHASE2 ACTIVE NOT_RECRUITING 40 — — Dec 7, 2016Jun 30, 2028May 5, 20261 United States
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Study Endpoints
Primary Endpoints
Number of participants with neutropenia that leads to permanent treatment discontinuation
From enrollment to treatment discontinuation; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 years.

Determined for each subject as a binary variable indicating whether or not the participant experienced any neutropenic adverse event (according to NCI Common Terminology for Adverse Events version 4.0) that leads to permanent treatment discontinuation

Secondary Endpoints
Overall Survival (OS)
From date of treatment start to date of death, or censored as described; assessed for approximately 4 years
Progression Free Survival (PFS)
From treatment start date to date of progression/death, or censored as described; assessed for approximately 4 years.
Number of participants with an objective response
From enrollment to best response while on study treatment; participants remain on treatment until disease progression, unacceptable toxicity, participant withdrawal, or investigator decision. Assessed for approximately 4 years.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A: First-line therapyEXPERIMENTALAnastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle
Cohort B: Maintenance therapyEXPERIMENTALAnastrozole by mouth daily and palbociclib by mouth Days 1-21 on a 28 day cycle
Interventions
NameTypeDescription
anastrozoleDRUGAnastrozole by mouth daily
PalbociclibDRUGPalbociclib by mouth daily days 1-21 every 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Are 18 years of age or older, who are either: * Postmenopausal, as defined by at least one of the following criteria: * Age greater than or equal to 60 years; * Age less than 60 years and cessation of regular menses for at least 12 consecutive months with no alternative p...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT02942355studyFirstPostDate: changed