drugset

drugset / Trial / NCT00789581

A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer

NCT00789581 ↗

Phase 3 Completed 614 enrolled SCRI Development Innovations, LLC Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, Phase III, open-label, multicenter study.

Timeline

Start: 2008-12
Primary completion: 2015-12
Completion: 2016-11

Publications

Background Yardley DA, Arrowsmith ER, Daniel BR, Eakle J, Brufsky A, Drosick DR, Kudrik F, Bosserman LD, Keaton MR, Goble SA, Bubis JA, Priego VM, Pendergrass K, Manalo Y, Bury M, Gravenor DS, Rodriguez GI, Inhorn RC, Young RR, Harwin WN, Silver C, Hainsworth JD, Burris HA 3rd. TITAN: phase III study of doxorubicin/cyclophosphamide followed by ixabepilone or paclitaxel in early-stage triple-negative breast cancer. Breast Cancer Res Treat. 2017 Aug;164(3):649-658. doi: 10.1007/s10549-017-4285-6. Epub 2017 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixabepilone	Small molecule	40 mg/m2	—
Comparator	Paclitaxel	Small molecule	80 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	—
Background	Doxorubicin	Other / unclassified	60 mg/m2	—

Indications