drugset / Trial / NCT01593020

Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2

NCT01593020

Phase 2 Completed 54 enrolled M.D. Anderson Cancer Center Eisai Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC). Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die. Paclitaxel is designed to block cancer cells from dividing, which may cause them to die. 5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die. Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.

Timeline

Start
2012-08-03
Primary completion
2020-11-04
Completion
2020-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Epirubicin Small molecule 100 mg/m2 Intravenous
Background fluorouracil Small molecule 500 mg/m2 Intravenous