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Clinical efficacy & safetyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-2 summaryPALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)SafetySafety overviewPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresIBRANCE long-term safetyGI and liver toxicitiesEffect of IBRANCE on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyRW evidenceValue of RWEWhat is real-world evidence?What is the value of RWE?P-REALITY and P-REALITY XP-REALITY OverviewP-REALITY OS and rwPFSP-REALITY X OverviewP-REALITY X OS and rwPFSIRISIRIS OverviewIRIS PFS and OSPOLARIS POLARIS OverviewPOLARIS Patient-Reported OutcomesMADELINEMADELINE OverviewMADELINE Patient CharacteristicsMADELINE Patient-Reported OutcomesPalomAGEPalomAGE OverviewRWE in Older Patients with mBCPatient-reported outcomesPALOMA-2: FACT-B scoresPALOMA-3: EORTC QLQ-C30 scoresPALOMA-3: Time to deterioration in pain symptomsDosingRecommended dosing scheduleRecommended dose modifications for AEsMonitoringOne scheduled monitoring provision ResourcesMaterials
What types of patients were enrolled in the PALOMA-3 clinical trial?

PALOMA-3 included a broad patient population, including 21% who were pre-/peri-menopausal and 21% of patients who had not received prior treatment for their metastatic disease (1st line)1

PALOMA-3 Patient Baseline Characteristics1
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Adapted from Cristofanilli M, et al. 2016.1
Data cut-off date: March 16, 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 one 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 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
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DFI = disease-free interval; ECOG = Eastern Cooperative Oncology Group; ET = endocrine therapy; FUL = fulvestrant; 
HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; IQR = interquartile range; 
ITT =
intention to treat; mBC = metastatic breast cancer; n = number of patients; PLA = placebo; SD = standard deviation.
References:Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
PALOMA-3
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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