print_label | resize_label

CONFIRM trial—FASLODEX 500 mg registration trial

FASLODEX 500 mg dose offers superior efficacy and disease control compared to 250 mg1

CONFIRM (trial 0064, ClinicalTrials.gov identifier NCT00099437) was an international, randomised, double-blind, parallel-group, multicentre phase III study comparing the efficacy and safety of FASLODEX 500 mg with that of FASLODEX 250 mg in postmenopausal women with oestrogen receptor-positive advanced disease at first recurrence or first progression on or after prior endocrine therapy (with an anti-oestrogen or aromatase inhibitor).1

Click on the image to see a larger view

Adapted from Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.

Primary endpoint

  • Progression free survival (PFS)

Secondary endpoints included:

  • Objective response rate (ORR)
  • Clinical benefit rate (CBR)
  • Duration of clinical benefit (DoCB)
  • Overall survival
  • Safety and tolerability
  • Quality of life

Key efficacy results1

Progression free survival (PFS)

FASLODEX 500 mg was significantly more effective than FASLODEX 250 mg in prolonging PFS.1

  • Hazard ratio: 0.80 (95% CI 0.68–0.94); P=0.006; corresponding to a 20% reduction in risk of progression
  • Median PFS of 6.5 months and 5.5 months for FASLODEX 500 mg and FASLODEX 250 mg, respectively
  • The treatment effect was consistent for all predefined clinical subgroups analysed

Objective response rate (ORR) and clinical benefit rate (CBR)

  • ORR in patients with measurable disease: 13.8% for FASLODEX 500 mg vs 14.6% for FASLODEX 250 mg (odds ratio: 0.94 [95% CI 0.57–1.55]; P=0.795)
  • CBR: 45.6% for FASLODEX 500 mg vs 39.6% for FASLODEX 250 mg (odds ratio: 1.28 [95% CI 0.95–1.71]; P=0.1)

Duration of clinical benefit (DoCB)

FASLODEX 500 mg offers proven control

  • DoCB: 16.6 months for FASLODEX 500 mg vs 13.9 months for FASLODEX 250 mg

Overall survival

FASLODEX 500 mg shows a trend for improved overall survival compared to the 250-mg dose

  • There was a trend for improved overall survival for patients treated with FASLODEX 500 mg compared with FASLODEX 250 mg (hazard ratio: 0.84 [95% CI: 0.69–1.03]; P=0.091)

Back to top

Reference

  1. Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.