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
- Postmenopausal women who have histologically-confirmed breast cancer with the
- 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
- 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.
- Subjects who have received more than one regimen of cytotoxic chemotherapy for
- Subjects with with CLINICALLY APPARENT brain metastases or extensive visceral
disease, including extensive hepatic involvement or pulmonary lymphangitic spread of
- 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).