NCT00789581

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

Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive AC followed by weekly paclitaxel.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Doxorubicin	Doxorubicin 60 mg/m2
DRUG	Cyclophosphamide	Cyclophosphamide 600 mg/m2
DRUG	Ixabepilone (Ixempra)	Ixabepilone 40 mg/m2
DRUG	Paclitaxel (Taxol)	Paclitaxel 80 mg/m2

Timeline

• Start date: 2008-12-01
• Primary completion: 2015-12-01
• Completion: 2016-11-01
• First posted: 2008-11-13
• Last updated: 2017-07-02
• Results posted: 2017-04-12

Locations

70 sites across 2 countries: United States, Puerto Rico