Bergh J et al. SABCS 2009;Abstract 23.

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Bergh J et al. SABCS 2009;Abstract 23. First Results from FACT - An Open-Label, Randomized Phase III Study Investigating Loading Dose of Fulvestrant Combined with Anastrozole versus Anastrozole at First Relapse in Hormone Receptor Positive Breast Cancer Bergh J et al. SABCS 2009;Abstract 23.

Introduction Many patients with advanced hormone-dependent breast cancer develop resistance to aromatase inhibitors such as anastrozole. Fulvestrant down regulates estrogen receptors and has similar single agent activity as anastrozole in pre-clinical studies (Cancer Res 2008;68:3516). The combination of anastrozole (A) and fulvestrant (F) may counteract resistance by increasing the level of estrogen blockade through synergistic modes of action. Current study objectives: Examine the safety and efficacy of the combination of F + A using a loading dose schedule of F in patients with relapsed hormone receptor positive breast cancer. Source: Bergh J et al. SABCS 2009;Abstract 23.

Anastrozole po, 1 mg daily Anastrozole po, 1 mg daily FACT: Phase III, Open-Label, Multicenter Trial of Combined Fulvestrant and Anastrozole Therapy Accrual: 514 Fulvestrant im, 500 mg day 0, 250 mg days 14 and 28 then 250 mg monthly + Anastrozole po, 1 mg daily Eligibility ER+ and/or PR+, at first relapse Postmenopausal or premenopausal rendered post-menopausal by adjuvant LHRH analogue* R Anastrozole po, 1 mg daily *In these cases, the LHRH analog must be continued throughout the study period Source: Bergh J et al. SABCS 2009;Abstract 23.

Efficacy – Full Analysis Set Efficacy parameter F + A (n=258) A (n=256) HR (95% CI) p-value Best objective response1 Complete response (CR) Partial response (PR) Stable disease (SD) ≥ 24 weeks 1.6% 14.3% 39.1% 13.3% 40.2% — Median time to progression (months) 10.8 10.2 0.99 (0.81, 1.20) p = 0.91 Overall survival (months) 37.8 38.2 1.00 (0.76, 1.32) p = 1.00 1Programmatically derived to RECIST criteria Source: Bergh J et al. SABCS 2009;Abstract 23.

Pre-specified Adverse Events* (Safety Population) Grouped event type F + A (n=256) A (n=254) p-value GI disturbances 28.9% 25.2% 0.37 Hot flushes 24.6% 13.8% < 0.01 Joint disorders 26.6% 27.6% 0.84 Thromboembolic events 2.3% 1.6% 0.75 Urinary tract infection 7.8% 5.9% 0.48 Weight gain 2.4% 1.00 *Shown are only those adverse events with an incidence of 2% or greater. Source: Bergh J et al. SABCS 2009;Abstract 23.

Conclusions Time to progression, overall survival and the clinical benefit rate were almost identical between the two study arms. Time to progression: 10.8 mos vs 10.2 mos Overall survival: 37.8 mos vs 38.2 mos Clinical benefit rate: 55.0% vs 55.1% F+A is well tolerated, however patients receiving the combination experienced significantly more hot flushes. Combining A with F offers no clinical efficacy advantage over anastrozole alone and should not be used. Source: Bergh J et al. SABCS 2009;Abstract 23.