drugset / Trial / NCT00470301

Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer

NCT00470301 ↗

Phase 1/2 Completed 60 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with combination chemotherapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy and to see how well they work in treating patients with stage II or stage III breast cancer.

Timeline

Start
2007-04
Primary completion
2013-09
Completion
2013-09

Outcome

Missed primary endpoint

paper Combination of the FTI T with weekly paclitaxel-AC is unlikely to be associated with a breast pCR rate of 35 % or higher PMID 24068539 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject tipifarnib Small molecule 100 mg Oral
Subject tipifarnib Small molecule 200 mg Oral

Indications