^* Disease relapse or progression had to occur after previous ET (with an aromatase inhibitor if the patient was postmenopausal or with tamoxifen if premenopausal or perimenopausal) while on or within 1 month after treatment in the advanced setting, or while on or within 12 months of completion of adjuvant therapy irrespective of menopausal status.^1
† All pre- or perimenopausal women received an LHRH agonist for at least 4 weeks prior to, and for the duration of, the trial.^1,2
‡ Investigator-assessed PFS according to RECIST (version 1.1).^1,2

Adapted from Cristofanilli M, et al. 2016.¹

^§ As 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 intent-to-treat fulvestrant plus placebo group.^1
** Disease-free interval was defined as time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy. Data for disease-free interval 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
†† Previous sensitivity to ET was based on randomisation.¹