Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of cancer cells. Letrozole may fight breast
 cancer by reducing the production of estrogen.

 PURPOSE: Phase IV trial to study the effectiveness of letrozole in treating postmenopausal
 women who have metastatic breast cancer that has been previously treated with tamoxifen.
OBJECTIVES: I. Determine the time to progression of postmenopausal women with metastatic
 breast cancer treated with letrozole (Femara) as first-line therapy. II. Determine the
 objective response rate, time to treatment failure, survival rate, and changes in symptom
 distress in patients treated with this regimen.

 OUTLINE: This is a multicenter study. Patients are stratified according to time to diagnosis
 of metastatic disease. Patients receive oral letrozole (Femara) daily. Treatment continues in
 the absence of disease progression or unacceptable toxicity.

 PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Diagnosis of metastatic breast cancer Measurable or evaluable
 disease Postmenopausal No spontaneous menses for at least 5 years (including
 chemotherapy-induced amenorrhea) Spontaneous menses within the past 5 years allowed if
 amenorrheic for at least 12 months and LH and FSH in postmenopausal normal range (including
 chemotherapy-induced amenorrhea) Bilateral oophorectomy Radiotherapy castration and
 amenorrheic for at least 3 months Hormone receptor status: Estrogen-receptor (ER) and/or
 progesterone-receptor (PR) positive No ER and PR negative or unknown tumors

 PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: See Disease
 Characteristics Performance status: Karnofsky 50-100% WHO 0-2 Life expectancy: Not
 specified Hematopoietic: Not specified Hepatic: Not specified Renal: Corrected serum
 calcium less than 11.6 mg/dL Other: No known hypersensitivity to any of the constituents of
 the study drug No history of noncompliance to medical regimens No unreliability Not
 pregnant or nursing Fertile patients must use effective contraception HIV negative

 PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy or
 biological response modifiers Chemotherapy: See Disease Characteristics Prior adjuvant or
 neoadjuvant chemotherapy with adjuvant tamoxifen allowed No concurrent anticancer
 chemotherapy Endocrine therapy: See Chemotherapy No other concurrent anticancer endocrine
 therapy (including steroids) Radiotherapy: See Disease Characteristics No concurrent
 radiotherapy to sole site of disease Concurrent radiotherapy to a limited area (e.g., for
 painful disease) allowed Surgery: See Disease Characteristics No prior adrenalectomy or
 hypophysectomy Other: At least 30 days since prior systemic investigational drugs At least
 7 days since prior topical investigational drugs No other concurrent investigational drugs
 Concurrent bisphosphonates (e.g., zoledronic acid) for bone metastasis allowed