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,*,†
FALCON STUDY DESIGN
FASLODEX 500 mg was studied vs anastrozole 1 mg in FALCON, a phase 3,
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
- 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|
|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.1
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.