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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

Monitoring

One Scheduled Monitoring ProvisionSupport & Resources

Summary of Prescibing Information

TabletCapsule

Recommended Dose 
Modifications for AEs

PALBACE®-associated AEs May Be Effectively Managed Using a Clear Dose-modification Schedule1

     

   

Adapted from Palbace. Local product document. 2021.1

   

Dose reductions or dose modifications due to any AE occurred in 38.4% of patients, receiving PALBACE® in randomised clinical studies regardless of the combination1

   

Dose Modification and Management of Haematological Toxicities1

   

Cycle 1

   

   

Cycle 2Cycle 2

Cycle 2

    

Cycle 3

     

  • CBC to be repeated on Day 1 of each following cycle:   
    • For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, CBCs for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.
    • Dose reductions for uncomplicated Grade 3 neutropenia should only be performed at the initiation of a cycle and not during a cycle  
  

Dose Modification and Management of Non-haematological Toxicities1 

   

All cycles

  

Dose modification includes temporary dose interruptions, cycle delays and/or reductions. Grading according to CTCAE 4.0.2  

  

  

*If further dose reduction below 75 mg/day is required, discontinue the treatment.1
†Applies to all haematological AEs except lymphopenia (unless associated with clinical events, e.g. opportunistic infections).
‡ANC: Grade 1: ANC <LLN to 1500/mm3; Grade 2: ANC 1000 to <1500/mm3; Grade 3: ANC 500 to <1000/mm3; Grade 4: ANC <500/mm3.
§Proactively monitor CBC.  

  

AE, adverse event; ANC, absolute neutrophil count; CBC, complete blood count; CTCAE, Common Terminology Criteria for Adverse Events; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; LLN, lower limit of normal.

  

References:

Palbace. Local product document. Pfizer; 2021. Version LPDPAB102021.

Common Terminology Criteria for Adverse Events (CTCAE). National Cancer Institute. Updated June 14, 2010. Accessed May 5, 2022. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
(®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India
 

    

PP-IBR-IND-0545  14 April 2023

Dosing

Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

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Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

 Learn more

Monitoring One scheduled monitoring provision Learn more


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