AROMASIN Safety and Tolerability Profile in Early Breast Cancer

AROMASIN adverse events (AEs) vs tamoxifen

AROMASIN is generally well tolerated, and AEs were usually mild to moderate.

Incidence of AEs (all grades) occurring in 5% of patients in any treatment group in IES (34.5-month median follow-up)

• At the 34.5-month median follow-up, events occurring at a rate of <5% that were more frequent with AROMASIN vs tamoxifen were osteoporosis (4.6% vs 2.8%), diarrhea (4.2% vs 2.2%), fractures (4.2% vs 3.1%), paresthesia (2.6% vs 0.9%), carpal tunnel syndrome (2.4% vs 0.2%), neuropathy (0.6% vs 0.1%), osteochondrosis (0.3% vs 0%), and trigger finger (0.3% vs 0%)
• Incidence of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were AROMASIN 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: AROMASIN 0.4%, tamoxifen 0.3%
• Discontinuation rates due to AEs were similar between AROMASIN and tamoxifen (6.3% vs 5.1%)
• The most common AEs observed at the 52.4-month follow-up and the 87-month follow-up were similar to those observed at the 34.5-month follow-up. Patients taking AROMASIN experienced a significant increase in the overall fracture rate vs tamoxifen: 7% vs 4.9% (P=0.002) at 52.4 months and 7.28% vs 5.22% (P=0.004) at 87 months


View the efficacy information related to this study.


Evaluated for its effect on bone health in 2 studies






*027 was a randomized, placebo-controlled, double-blind, parallel-group, phase 2 study. It was designed to assess the effects of AROMASIN on bone metabolism, hormones, lipids, and coagulation factors over the course of 2 years of treatment in postmenopausal women with early breast cancer at low risk for recurrence (N=147). Exclusion criteria included prior bisphosphonate therapy and vitamin D and/or calcium supplements >500 mg/day within the past 6 months. Median duration of observation, including the posttreatment period, was 30 months.
^†In the IES bone substudy, a total of 206 patients were randomized; at data cut-off, 24-month BMD data were available for 29 patients in the AROMASIN arm and 38 patients in the tamoxifen arm.



• In Study 027, no patients with normal BMD at baseline became osteoporotic at 2 years of treatment¹
• In the IES bone study, AROMASIN was compared with tamoxifen, which has a positive effect on bone

Reductions in BMD over time are seen with the use of AROMASIN.

In the 027 study of AROMASIN versus placebo on bone and lipid metabolism, the most common AEs reported in >10% of patients (n=146) were hot flushes (32.9% vs 24.7%), arthralgia (28.8% vs 28.8%), increased sweating (17.8% vs 20.6%), alopecia (15.1% vs 4.1%), hypertension (15.1% vs 6.9%), insomnia (13.7% vs 15.1%), nausea (12.3% vs 16.4%), fatigue (11.0% vs 19.2%), and abdominal pain (11.0% vs 13.7%), respectively. Discontinuation rates due to AEs (AROMASIN vs placebo) were 12.3% and 4.1%.¹