Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Lonafarnib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. It is not yet known whether giving anastrozole with lonafarnib is more effective than giving anastrozole with placebo in treating breast cancer. PURPOSE: This randomized phase II trial is studying anastrazole given with lonafarnib to see how this regimen works compared to anastrozole given with placebo in treating postmenopausal women with stage IIIB, stage IIIC, or stage IV breast cancer.


Study summary:

OBJECTIVES: Primary - Compare progression-free survival of postmenopausal women with hormone receptor-positive stage IIIB, IIIC, or IV breast cancer treated with anastrozole in combination with lonafarnib vs placebo. Secondary - Compare the objective response rate in patients treated with these regimens. - Compare duration of response in patients treated with these regimens. - Compare overall survival of patients treated with these regimens. - Determine exposure to these regimens in these patients. - Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral anastrozole once daily and oral lonafarnib twice daily on days 1-28. - Arm II: Patients receive oral anastrozole once daily and oral placebo twice daily on days 1-28. In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A maximum of 110 patients (55 per treatment arm) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Stage IIIB, IIIC, or IV disease - Measurable or evaluable disease - Measurable disease defined as masses with clearly defined margins AND at least 1 diameter ≥ 20 mm by radiography OR ≥ 10 mm by spiral CT scan - Evaluable disease defined as masses without clearly defined margins on radiological images OR no diameter ≥ 20 mm - Patients with bone only disease eligible if disease is evaluable - No brain metastases - Hormone receptor status: - Estrogen receptor- and/or progesterone receptor-positive PATIENT CHARACTERISTICS: Age - Postmenopausal Sex - Female Menopausal status - Postmenopausal Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10.0 g/dL Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2 times ULN - Alkaline phosphatase ≤ 2.5 times ULN Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No significant QTcF prolongation (i.e., QTcF ≥ 470 msec) Other - No situation or condition that would preclude study participation - No known or suspected hypersensitivity to any excipients of lonafarnib (e.g., povidone, poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate) PRIOR CONCURRENT THERAPY: Biologic therapy - No prior or concurrent biologic therapy - No prior or concurrent immunotherapy Chemotherapy - Prior adjuvant chemotherapy allowed provided the disease-free interval from completion of treatment to diagnosis of advanced or metastatic disease is ≥ 12 months - No prior chemotherapy for advanced disease - No concurrent chemotherapy Endocrine therapy - Prior adjuvant tamoxifen allowed provided the disease-free interval from completion of treatment to diagnosis of advanced or metastatic disease is ≥ 12 months - No prior hormonal therapy for advanced disease - No prior aromatase inhibitors - More than 2 days since prior and no concurrent high-dose chronic steroids - No concurrent hormone replacement therapy - No other concurrent hormonal therapy Radiotherapy - Prior radiotherapy allowed - No concurrent radiotherapy except palliative radiotherapy for bone metastasis Surgery - Not specified Other - More than 30 days since prior investigational drugs - No prior farnesyl transferase inhibitors - More than 2 days since prior and no concurrent use of any of the following inducers or inhibitors of CYP3A4: - Ethinyl estradiol - Gestodene - Itraconazole - Ketoconazole - Cimetidine - Erythromycin - Carbamazepine - Phenobarbital - Phenytoin - Rifampin - Sulfinpyrazone - No concurrent participation in another clinical trial - No other concurrent investigational therapy


NCT ID:

NCT00098904


Primary Contact:

Principal Investigator
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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