Status:
COMPLETED
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- Postmenopausal women who have histologically-confirmed breast cancer with the following characteristics:
- estrogen and/or progesterone receptor positive,
- locally advanced disease
- distant metastatic disease, stage 4
- Subjects eligible for single-agent treatment with aromatase inhibitors for current disease.
- Subjects taking biophosphonates are allowed if they begin bisphosphonate therapy AT LEAST two weeks prior to randomization.
- Measurable disease (masses with clearly defined margins on radiological images and at least one diameter \>=20 mm\[\>=10 mm if spiral CT\]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter \>= 20 mm). Subjects with bone disease only are permitted if disease is evaluable.
- ECOG Performance Status of 0 or 1.
- Sufficient bone marrow reserve.
- Adequate hepatic and renal function: laboratory values within protocol requirements.
Exclusion
- Subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease.
- Subjects with with CLINICALLY APPARENT brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor.
- Subjects with prior treatments with FTIs.
- Subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (Providone, Poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00081510
Start Date
December 1 2003
End Date
May 1 2009
Last Update
April 15 2015
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