Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Anastrozole With or Without Lonafarnib in Treating Postmenopausal Women With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

Basic Trial Information

Objectives

Primary

1. 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

1. Compare the objective response rate in patients treated with these regimens.
2. Compare duration of response in patients treated with these regimens.
3. Compare overall survival of patients treated with these regimens.
4. Determine exposure to these regimens in these patients.
5. Compare the safety of these regimens in these patients.

Entry 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

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

Patient Characteristics:

Age

• Postmenopausal

Sex

• Female

Menopausal status

• Postmenopausal

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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)

Expected Enrollment

A maximum of 110 patients (55 per treatment arm) will be accrued for this study.

Outcomes

Progression-free survival

Objective response rate
Overall survival
Duration of response

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

John Glaspy, MD, MPH, Principal investigator		Ph: 310-794-4955; 888-798-0719

Registry Information
Official Title		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
Trial Start Date		2004-09-20
Registered in ClinicalTrials.gov		NCT00098904
Date Submitted to PDQ		2004-10-06
Information Last Verified		2006-04-11
NCI Grant/Contract Number		CA16042

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