PFS (Primary Endpoint)

PALOMA-3 PFS

In PALOMA-3, PALBACE^® in combination with fulvestrant in first line or later doubled mPFS versus placebo + fulvestrant in patients with progression on/after ET.^1,2,*

PALOMA-3 PFS* Kaplan-Meier Curve^1,2

In a randomised (in the ratio of 2:1), double-blind, Phase III trial of women with HR+/HER2- mBC whose disease progressed following ET (N=521)²

Adapted from Palbace Local product document. Version 7,2023.

Datacut-off date: 23 October 2015.

lmprovement in PFS Was Seen Across a Broad Range of Patients

PALBACE^® in combination with fulvestrant reduced the risk of disease progression versus placebo + fulvestrant in multiple predefined patient subpopulations.^2,3

Subgroups included:   

• premenopausal/perimenopausal women
• Elderly patients (≥65 years)
• Patients with visceral metastases

*Evaluated according to RECIST Version 1.1.^2
†Data cut-off date: 16 March 2015.
^‡Updated non-prespecified analysis.
^§Visceral metastasis was defined as lung, liver, brain, pleural or peritoneal involvement.^2
||Sensitivity to prior hormonal therapy is defined as either a) documented clinical benefit (i.e. CR, PR or SD ≥24 weeks) to at least 1
prior hormonal therapy in the metastatic setting or b) at least 24 months of adjuvant hormonal therapy prior to recurrence.^3
¶DFI is time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy.³
**AI: anastrozole, letrozole or exemestane.
^††Anti-oestrogen: tamoxifen, tamoxifen citrate, toremifene or toremifene citrate.
^‡‡Other: neither an AI nor an anti-oestrogen.

CI, confidence interval; CR, complete response; ECOG PS, Eastern Oncology Cooperative Group performance status; ET, endocrine therapy; FUL, fulvestrant; HR, hazard ratio; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; ITT, intention to treat; mBC, metastatic breast cancer; mPFS, median progression-free survival; n, number of patients; PFS, progression-free survival; PLA, placebo; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; SD, standard deviation.

References: