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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


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

John A. Glaspy, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000396775

NCT ID:

NCT00098904

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781