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JAMA. 2002;288:2112.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved anastrozole (Arimidex, AstraZeneca Pharmaceuticals LP, Wilmington, Del) for adjuvant treatment of postmenopausal women with hormone receptor–positive early breast cancer. The drug, a nonsteroidal aromatase inhibitor, had been approved for two indications in postmenopausal women, including first-line treatment of locally advanced or metastatic breast cancer and treatment of advanced breast cancer in women with disease progression following tamoxifen therapy.

The new indication was approved on the basis of the preliminary results of a multicenter, double-blind trial in 9366 postmenopausal women with operable breast cancer, about 84% of whom were hormone receptor–positive. All participants were randomized to adjuvant treatment with 1 mg of anastrozole daily, 20 mg of tamoxifen daily, or a combination of the two treatments for 5 years or until recurrence of the disease.

The primary end point of the ongoing trial is recurrence-free survival, defined as time to distant or local recurrence, contralateral breast primary, . . . [Full Text of this Article]

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