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   

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.¹ 

^†Data were unavailable for 1 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 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.