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 MONOTHERAPY AFTER PRIOR ENDOCRINE THERAPY
The CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic Breast Cancer) Trial was a randomised, double-blind, controlled phase 3 study comparing FASLODEX 500mg vs FASLODEX 250 mg in 736 postmenopausal women with advanced breast cancer (ABC) who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.2,4
- Progression-free survival (PFS) was the primary endpoint and was defined as the time between
randomisationand the earliest evidence of progression or death from any cause2,4 Objectiveresponse rate was a secondary endpoint and was defined as the number (%) of patients with complete response or partial response2,4