drugset / Trial / NCT00821886

Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer

NCT00821886

NaSingle-groupOpen-labelTreatment

Summary

In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.

Timeline

Start
2009-02
Primary completion
2011-07
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Ixabepilone Small molecule 40 mg/m2 Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications