FASLODEXTM is indicated as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:

  • Not previously treated with endocrine therapy, or
  • With disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy

Faslodex is also indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

  • In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinising hormone releasing hormone agonist.



FASLODEX 500 mg was studied in combination with palbociclib 125 mg vs FASLODEX plus placebo (the control arm).* PALOMA-3, a phase 3, international, randomised, double-blind, parallel-group, multicentre study in women (N=521) with HR-positive, HER2-negative ABC or mBC, regardless of their menopausal status, whose disease progressed on or after prior endocrine therapy.3,4

Patients were randomised 2:1 to FASLODEX plus palbociclib or the control arm, and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre-/peri- vs postmenopausal), and presence of visceral metastases.3,4

The primary endpoint was investigator-assessed PFS, evaluated according to RECIST v.1.1.3,4

Pre- or postmenopausal women with ER-resistant, HR+, HER2- ABC were randomised to Faslodex + palbociclib (n=347) or Faslodex + placebo (n=174)3
Pre- or postmenopausal women with ER-resistant, HR+, HER2- ABC were randomised to Faslodex + palbociclib (n=347) or Faslodex + placebo (n=174)3

Adapted from Cristofanilli, M et al. Lancet Oncol. 2016;17(4):425-439.3



Prior therapy in PALOMA-3
  • All patients received prior systemic therapy3,4      
  • 75% of patients received a previous chemotherapy regimen, 34% of which was in the metastatic setting       
  • Patients were permitted to have 1 prior line of chemotherapy for advanced disease and/or multiple lines of prior endocrine therapy3

ABC=advanced breast cancer; AI=aromatase inhibitor; ER=oestrogen receptor; HER2=human epidermal growth factor receptor 2; HR=hormone receptor; mBC=metastatic breast cancer; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

*Patients in both arms received FASLODEX 500 mg by intramuscular injection on Days 1, 15, and 29 of the first month, and every 28 (± 3) days thereafter, and either oral palbociclib 125 mg or placebo for 21 consecutive days followed by 7 days off treatment.3

† Women who were either premenopausal  or perimenopausal  were therapeutically induced to become postmenopausal and represented 20.7% of the study population.3,4

Disease relapse or progression had to occur during or within 1 month after treatment in the advanced setting, or during or within 12 months of completion of adjuvant therapy.

§All pre/perimenopausal women had to have commenced treatment with a LHRHa at least 4 weeks before randomisation. During the treatment period, all pre/perimenopausal women received LHRHa at the time of fulvestrant administration.