A Phase II Trial of Tipifarnib (R115777, Zarnestra™) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Hormone Receptor-Positive Breast Cancer
PRIMARY OBJECTIVES:
I. To determine the efficacy of tipifarnib (R115777, Zarnestra™) in combination with
fulvestrant based on clinical benefit rate (CBR, a combination of complete response rate,
partial response rate, and stable disease for more than 24 weeks) in postmenopausal women
with hormone receptor-positive metastatic breast cancer who have progressive disease after
first-line endocrine therapy.
SECONDARY OBJECTIVES:
I. To determine the median time to progression (TTP) and duration of response of tipifarnib
(R115777, Zarnestra™) in combination with fulvestrant in postmenopausal women with hormone
receptor-positive metastatic breast cancer.
II. To determine the median overall survival of tipifarnib (R115777, Zarnestra™) in
combination with fulvestrant in postmenopausal women with hormone receptor- positive
metastatic breast cancer who have progressive disease after first-line endocrine therapy.
III. To determine the toxicity profile of tipifarnib (R115777, Zarnestra™) in combination
with fulvestrant versus fulvestrant alone (from historical control) in postmenopausal women
with hormone receptor positive metastatic breast cancer who have progressive disease after
first-line endocrine therapy.
OUTLINE:
Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on
days 1-21. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity*.
NOTE: *Fulvestrant continues even if tipifarnib is held for toxicity.
Patients are followed every 3 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate (CBR) (CR rate, PR rate, and SD)
Up to 24 weeks
No
Linda Vahdat
Principal Investigator
Montefiore Medical Center
United States: Food and Drug Administration
NCI-2012-02982
NCT00082810
March 2004
Name | Location |
---|---|
Montefiore Medical Center | Bronx, New York 10467-2490 |