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.

Monotherapy in endocrine therapy naïve patients

FALCON: the first phase 3, head-to-head trial of FASLODEX 500 mg vs anastrozole 1 mg1,*,†


FASLODEX 500 mg was studied vs anastrozole 1 mg in FALCON, a phase 3, randomised, double-blind, double-dummy, multicentre study in postmenopausal women (N=462) who had not previously been treated with endocrine therapy.1,4All patients had locally advanced breast cancer or mBC.All patients tested ER+ and/or PgR+, and most (except 1 patient) tested HER2-negative.1

Patients were randomised 1:1 to FASLODEX or anastrozole and stratified by disease setting (locally advanced or metastatic), use of prior chemotherapy for advanced disease, and the presence or absence of measurable or non-measurable lesions.1,4
The primary endpoint of the FALCON Trial was investigator-assessed progression-free survival (PFS), evaluated according to RECIST v.1.1.1,4

Approximately 99% of patients in FALCON had not been previously treated with endocrine therapy.1 Studying oestrogen receptor targeting with FASLODEX vs aromatase inhibition with anastrozole in an endocrine therapy-naïve patient population allowed for:

  • Direct comparison between the 2 drugs, which have different mechanisms of action1
  • Study without the confounding effects of previous adjuvant endocrine therapy exposure1
Key Inclusion Criteria1  
Postmenopausal women
WHO performance status of 0-2
≥1 measurable or non-measurable lesion
Key Exclusion Criteria1  
Previous endocrine therapy for breast cancer
Presence of life-threatening visceral metastases
Previous systemic therapy for breast cancer except for 1 line of cytotoxic chemotherapy

*The efficacy and safety of FASLODEX 500 mg vs anastrozole 1 mg were previously studied in the phase 2 FIRST Trial, a trial composed of a different patient population than in the FALCON Trial.1,5
Patients in the FASLODEX arm received intramuscular injections of FASLODEX into the buttocks on Days 0, 14, 28, and every 28 (± 3) days thereafter, and placebo anastrozole as a daily oral tablet. Patients in the anastrozole arm received anastrozole as a daily oral tablet, and placebo FASLODEX injections on Days 0, 14 (± 3) days, 28 (± 3) days and every 28 (± 3) days thereafter.

ER+=oestrogen receptor positive; HER2=human epidermal growth factor receptor 2;  mBC=metastatic breast cancer;  PgR+=progesterone receptor positive; RECIST=Response Evaluation Criteria in Solid Tumors; WHO=World Health Organization.