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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

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Patient Baseline Characteristics

What types of patients were enrolled in the PALOMA-3 clinical trial?

   

PALOMA-3 included a broad patient population, including 21% who were premenopausal/perimenopausal and 21% of patients who had not received prior treatment for their metastatic disease (first line).1

   

PALOMA-3 Patient Baseline Characteristics1   

   

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Example

Adapted from Cristofanilli M, et al. 2016.1

   

Data cut-off date: 16 March 2015. Data are number (%), unless otherwise specified. Because of rounding, some percentages do not total 100% when summed.

   

   

*Per protocol, visceral refers to lung, liver, brain, pleural and peritoneal involvement, and was a study stratification factor.

Data were unavailable for 1 patient in the ITT fulvestrant + placebo group.

DFI was defined as time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy. Data for DFI were available only for patients who were initially diagnosed with early breast cancer and then experienced disease relapse; percentages are calculated on the basis of available data.1

§Patients did not receive chemotherapy in the context of metastatic disease.1 

||Previous sensitivity to ET was based on randomisation.1 

For the classification of receptor status (≥ median of distribution, < median of distribution), the H-score was used. The median was calculated on the basis of the number of patients who were tested by the central laboratory (250 patients in the fulvestrant plus palbociclib group and 130 patients in the fulvestrant plus placebo group).1

   

DFI, disease-free interval; ECOG PS, Eastern Cooperative Oncology Group performance status; ET, endocrine therapy; FUL, fulvestrant; IQR, interquartile range; ITT, intention to treat; LET, letrozole; n, number of patients; PLA, placebo; SD, standard deviation.

   

Reference: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.

   

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.

    

PP-IBR-IND-0462 27 July 2022

PALOMA-3

   

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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Monitoring

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