A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer

Date de début de l'étude : 1 décembre 2003

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).