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.

Exclusion Criteria:

* Subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease.
* Subjects with with CLINICALLY APPARENT brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor.
* Subjects with prior treatments with FTIs.
* Subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (Providone, Poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).