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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 SummaryTolerability/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 Provision
Support & Resources

Summary of Prescibing Information

TabletCapsule

Confidence Built on Strength 

A) For Women:

   

PALBACE® (palbociclib) is indicated for the treatment of HR+, HER2- locally ABC or mBC:

  • In combination with an AI
     
  • In combination with fulvestrant in women who have received prior ET

In premenopausal or perimenopausal women, ET should be combined with an LHRH agonist.

     

B) For Men:

   

PALBACE® (palbociclib) is indicated for the treatment of HR+, HER2- ABC or mBC in combination with:

  • An AI as initial endocrine-based therapy
     
  • Fulvestrant in patients who have received prior therapy

Click here to see the Full Prescribing lnformation for tablet.

     

Click here to see the Full Prescribing lnformation for capsule.

  


Provide Your Patients With Proven Strength


A broad range of women with HR+/HER2- mBC may benefit from PALBACE® combination therapy.1-9 PALBACE® is the first CDK4/6 inhibitor supported by data from clinical trials1-4 and RWE.5-7 
 

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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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Real-world Evidence

With RCT data, PALBACE® RWE can help
improve the understanding of outcomes in
patients with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose
modifications for AEs

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Monitoring

One scheduled monitoring provision

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Pfizer Products India Private Limited (Pfizer) The Capital – B Wing, 1802, Plot
No. C-70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai – 400 051, India.

® Trademark Proprietor – Pfizer Inc., USA
Licensed User – Pfizer Products India Private Limited, India 

To view the summary of prescribing information for PALBACE®, for tablet please click here, for capsule please click here.

For the use only of Registered Medical
Practitioners or a Hospital or a Laboratory.
Full prescribing information available on request.

  

ABC,  advanced breast cancer; AE, adverse event; AI, aromatase inhibitor; CDK, cyclin-dependent kinase; ET, endocrine treatment; HER2-, human epidermal growth factor 2-negative; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mBC, metastatic breast cancer; QoL, quality of life; RCT, randomised clinical trial; RWE, real-world evidence. 

  

References:

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

Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.

Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719-729.

Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016;17(4):e136] [published correction appears in Lancet Oncol. 2016;17(7):e270]. Lancet Oncol. 2016;17(4):425-439.

Cristofanilli M, Rugo HS, Im SA, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): updated analyses from PALOMA-3. Presented at: ASCO 2021 Annual Meeting; June 5, 2021; Virtual.

Rugo HS, Cristofanilli M, Loibl S, et al. Prognostic factors for overall survival in patients with hormone receptor-positive advanced breast cancer: analyses from PALOMA-3. Oncologist. 2021;26(8):e1339-e1346.

DeMichele A, Cristofanilli M, Brufsky A, et al. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 2021;23(1):37.

Taylor-Stokes G, Mitra D, Waller J, Gibson K, Milligan G, Iyer S. Treatment patterns and clinical outcomes among patients receiving palbociclib in combination with an aromatase inhibitor or fulvestrant for HR+/HER2-negative advanced/metastatic breast cancer in real-world settings in the US: results from the IRIS study. Breast. 2019;43:22-27.

Waller J, Mitra D, Mycock K, et al. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in Argentina: the IRIS study. J Glob Oncol. 2019;5:JGO1800239.

   

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.

    

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