Conditions: Metastatic Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

Brief summary:
A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study will determine the rate of progression-free survival of patients with metastatic breast cancer who receive lonafarnib.

Detailed description:
OUTLINE: This is a multi-center study

Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if encountered).

ECOG Performance Status 0-1

Life Expectancy: Not Specified

Hematopoietic:

* Platelets \> 100 K/mm3
* Absolute Neutrophil Count (ANC) \> 1.2 K/mm3
* Hemoglobin ≥ 9 g/dl
* Serum potassium ≥ 3.3 mmol/L

Hepatic:

* Aspartate transaminase (AST) ≤ 5.0 x ULN
* Alanine transaminase (ALT) ≤ 5.0 x ULN
* Total bilirubin \< 1.5 x ULN

Renal:

* Calculated creatinine clearance (using Cockcroft-Gault formula) \> 45 cc/min

Cardiovascular:

* No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter

Arms:
arm 1: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Interventions: intervention 1: Lonafarnib
Intervention descriptions: intervention 1: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Protocol document: