Primary Objective(s):

• To compare the activity (progression-free survival, PFS) of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive advanced breast cancer.

Secondary Objective(s):

• To determine the effects of anastrozole in combination with lonafarnib on objective of lonafarnib and anastrozole to the subject population.

Condition	Treatment or Intervention	Phase
Breast Cancer	Drug: farnesyl Protein Transferase Inhibitor - Lonafarnib	Phase II

Genders Eligible for Study:  Female

Criteria

Diagnosis & criteria for inclusion:

• Postmenopausal women with a histologicaly confirmed diagnosis of hormone receptor (estrogen receptor and/or progresterone receptor) positive locally advanced or metastatic breast cancer (Stage 3b, 3c, or 4).
• No prior hormonal therapy or chemotherapy for advanced disease. Prior radiotherapy is permitted.
• Subjects relapsing in adjuvant tamoxifen therapy or after discontinuing adjuvant tamoxifen are eligible as long as the disease-free interval from discontinuation of tamoxifen treatment to diagnosis of advanced/metastatic disease is at least 12 months.
• Subjects taking bisphosphonates who are stable are allowed on the study. Measurable disease (masses with clearly defined margins on radiological images and at least one diameter less than 20mm) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter less than 20mm). Subjects with bone disease only are permitted if disease is evaluable.

Inclusion Criteria:

• ECOG Performance Status of 0 or 1.
• Subjects with brain metastases are excluded.
• Sufficient bone marrow reserved
• Adequate hepatic function: laboratory values within protocol requirements.
• Friderica QTc (QTcF) interval less than 470 msec: no symptomatic arrhythmias, greater than first degree AV block, or a documented ischemic event.
• No prior treatment with FTIs.
• Subjects with a known or suspected hypersensitivity to any excipietns in the lonafarnib formulation (Povidone, Poloxamer 188, croscarmellose soldium, silicon dioxice, and magnesium stearate) are excluded.

Panama
      Instituto Oncologico Nacional, Panama,  Panama; Recruiting

Study ID Numbers:  P03480
Record last reviewed:  March 2004
Record first received:  April 14, 2004
ClinicalTrials.gov Identifier:  NCT00081510
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29