Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Trial of Tipifarnib (R115777, Zarnestra™) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Hormone Receptor-Positive Breast Cancer
This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line therapy.
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.
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