Invasive Breast Cancer Prevention Trials:

The NSABP P1 Trial

Trial objective: To determine whether tamoxifen administered for 5 years prevented invasive breast cancer in women at increased risk of the disease.¹

P1 study design: Patients were randomized to receive either placebo (6,707) or tamoxifen 20 mg/day (6,681) for 5 years.¹

P1 patient population: 13,388 women at increased risk for breast cancer because they met one of the following criteria¹:

• Age 60 years or older, or
• Age 35-59 years^† and had a 5-year predicted risk for breast cancer of at least 1.66% based on the Gail model, or
• Had a history of lobular carcinoma in situ (LCIS)

Results: Tamoxifen reduced the risk of invasive breast cancer over 5 years in women at increased risk.¹

The NSABP P2 (STAR) Trial

Trial objective: To compare the relative effects and safety of EVISTA and tamoxifen on the risk of developing invasive breast cancer and other disease outcomes.²

P2 (STAR) study design: 19,747 patients were randomized to receive either tamoxifen 20 mg/day (9,726) or EVISTA 60 mg/day (9,745) for a maximum of 5 years.²

• All were postmenopausal women age 35 and older^†
• All participants were at high risk of invasive breast cancer based on the Gail model score (≥1.66%) or had a history of LCIS treated with surgery alone

P2 (STAR) patient characteristics: 91% of participants were age 50 or older.^†,2

• Mean age = 59 years
• Mean Gail score = 4.03% ± 2.17%

A Gail score ≥1.66% is defined as high risk.

Results: The incidence rates of invasive breast cancer were similar (EVISTA 4.4 and tamoxifen 4.3 per 1,000 women per year).

^†EVISTA is only indicated for postmenopausal women. The average age of menopause is 51.⁴

EVISTA vs tamoxifen in the P2 (STAR) trial²

• Patients with a history of AH at the entry of the trial had similar incidence rates of invasive breast cancer in both treatment groups
• Patients with a history of LCIS at entry of the trial had similar incidence rates of invasive breast cancer in both treatment groups

1. J Natl Cancer Inst. 1998;90:1371-1388.
2. JAMA. 2006;295:2727-2741.
3. Data on file, Lilly Research Laboratories (EVI20070910).
4. Harrison's Principles of Internal Medicine. 16th ed. New York, NY: McGraw-Hill Companies, Inc;2005:2209.

Important Safety Information for EVISTA

Contraindications

• EVISTA is contraindicated in nursing women and in women who are or may become pregnant, as it may cause fetal harm. EVISTA is also contraindicated in women with active or past venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Warnings and Precautions

• In a study of postmenopausal women at high risk for cardiovascular disease taking EVISTA, there was no increase in the incidence of stroke; however, there was an increase in death due to stroke. EVISTA also did not increase or decrease the incidence of overall mortality, cardiovascular mortality, or heart attack. The risk-benefit balance should be considered in women at risk for stroke, such as those with prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking.
• EVISTA should be used with caution in patients with hepatic impairment or moderate/severe renal impairment since safety and efficacy have not been established in these patients.
• The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended.

Adverse Reactions

• The common adverse reactions considered to be drug related:

• Adverse reactions occurring in the clinical trials at a frequency ≥2.0% in either group and in more EVISTA-treated women than in placebo-treated women include:

• The majority of adverse reactions occurring during the osteoporosis prevention and treatment studies were mild and generally did not require discontinuation of therapy.

For additional information, please see the full Prescribing Information and Medication Guide.

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EVISTA is a once-daily 60-mg tablet. Supplemental calcium and/or vitamin D should be added to diet if daily intake is inadequate.

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