CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
fulvestrant +1 moredrug
Likely dose
Tipifarnib IV and fulvestrant intramuscularly (specific doses not provided in trial description)AI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Postmenopausal status
  • Stage IV disease or inoperable locally advanced disease (stage IIIB/IIIC)
  • ER- and/or PR-positive disease
Key exclusion· 8
  • Prior chemotherapy for metastatic disease
  • Radiotherapy within 4 weeks prior to enrollment
  • Two or more prior doses of fulvestrant
  • Rapidly progressive, life-threatening metastases including extensive hepatic involvement (>50% liver), symptomatic lymphangitic metastases, or brain/leptomeningeal involvement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00082810
NCT00082810Phase 2Completed

A Phase II Trial of Tipifarnib (R115777, Zarnestra™) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Hormone Receptor-Positive Breast Cancer

National Cancer Institute (NCI)·interventional·Posted May 19, 2004·Updated Nov 1, 2018

In Brief

A Phase 2 clinical trial evaluating fulvestrant and tipifarnib for Estrogen Receptor-positive Breast Cancer and 4 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2004
Enrollment StartMar 1, 2004
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 22.1 years ago

Interventions

fulvestrantdrug

Given intramuscularly

tipifarnibdrug

Given IV