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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Patient baseline characteristics

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.1 
Data were unavailable for one patient in the ITT fulvestrant + placebo group.1 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).1Explore More PALOMA-2

See PALOMA-2 patient baseline characteristics

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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

A broad range of patients with HR+/HER2- mBC are eligible for Palbociclib Pfizer + letrozole combination therapy

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