Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)

Inclusion Criteria

• •Postmenopausal women who have histologically-confirmed breast cancer with the following characteristics:
• •* estrogen and/or progesterone receptor positive,
• •* locally advanced disease
• •* distant metastatic disease, stage 4
• •Subjects eligible for single-agent treatment with aromatase inhibitors for current disease.
• •Subjects taking biophosphonates are allowed if they begin bisphosphonate therapy AT LEAST two weeks prior to randomization.
• •Measurable disease (masses with clearly defined margins on radiological images and at least one diameter \>=20 mm\[\>=10 mm if spiral CT\]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter \>= 20 mm). Subjects with bone disease only are permitted if disease is evaluable.
• •ECOG Performance Status of 0 or 1.
• •Sufficient bone marrow reserve.
• •Adequate hepatic and renal function: laboratory values within protocol requirements.