Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082810
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2004-05-14
Brief Title:
Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Tipifarnib R115777 Zarnestra in Combination With Fulvestrant Faslodex in Postmenopausal Hormone Receptor-Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62204 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62204 |
| 6205 | OTHER | None | None |