FASLODEXTM
(fulvestrant)

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

CONFIRM STUDY EFFICACY

CONFIRM STUDY PRIMARY ENDPOINT: PFS

FASLODEX 500 mg demonstrated efficacy as monotherapy in postmenopausal women with hormone receptor (HR)-positive ABC with disease progression following endocrine therapy2,4

Median PFS 6.5 months with Faslodex 500mg vs 5.5 months with Faslodex 250 mg (HR=0.80; 95% CI 0·68–0·94).2
Median PFS 6.5 months with Faslodex 500mg vs 5.5 months with Faslodex 250 mg (HR=0.80; 95% CI 0·68–0·94).2

Adapted from Di Leo A, et al. J Clin Oncol. 2010;28(30):4594-4600.2

CONFIRM final OS analysis at 75% maturity*6

Median OS 26.4 months with Faslodex 500mg vs 22.3 months with Faslodex 250 mg (HR=0.801; 95% CI 0·69–0·96).2
Median OS 26.4 months with Faslodex 500mg vs 22.3 months with Faslodex 250 mg (HR=0.801; 95% CI 0·69–0·96).2

Nominal p-value with no adjustments made for multiplicity between the initial overall survival analysis at 50% maturity and the updated survival analysis at 75% maturity. Protocol was amended after PFS result. Crossover of treatment was allowed after PFS result.

Adapted from Di Leo A, et al. J Natl Cancer Inst. 2014;106(1):djt337

*No adjustments for multiplicity were made.