Randomised phase 3 dou
ble-b
lind trial at 144 centres in 17 countries
(NCT01942135)
PALOMA-3: Study design
a
All received goserelin.
b
Must have progressed on adjuvant tamoxifen or prior endocrine
therapy (pre-/perimenopausal)
or aromatase inhibitor therapy (postmenopausal).
c
Patients randomised.
d
Administered on Days 1 and 15 of Cycle 1, then every 28 d.
Turner NC, et al. N Engl J Med 2015
Placebo
(3 wks on/1 wk off)
+
Fulvestrant
d
(500 mg IM q4w)
Palbociclib
(125 mg QD;
3 wks on/1 wk off)
+
Fulvestrant
d
(500 mg IM q4w)
• Visceral metastases
• Sensitivity to prior
hormonal therapy
• Pre-/peri- vs. postmenopausal
2:1 randomisation
N=521
c
Stratification:
•
HR+ HER2– ABC
•
Pre-/peri-
a
or postmenopausal
b
•
Progressed on prior endocrine
therapy:
–
On or within 12 mo of completion
of adjuvant treatment
–
On or within 1 mo of treatment for
ABC
•
≤1 prior chemotherapy regimen for
advanced cancer
n=347
n=174
