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Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
An Open-Label, Randomized, Multicenter, Phase 3 Study to Determine the Safety, Tolerability, and Tumor Response of Oraxol and Its Comparability to IV Taxol or Generic IV Paclitaxel in Subjects With Metastatic Breast Cancer

Clinical Trial Summary

To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer

Clinical Trial Description

This is a Phase 3, open-label, randomized, multicenter study in approximately 360 adult female subjects with histologically- or cytologically-confirmed breast cancer that is metastatic for whom treatment with IV paclitaxel monotherapy has been recommended by their oncologist. Approximately 400 subjects will be enrolled to provide 360 evaluable subjects. The subjects must have measurable metastatic target lesion disease as per RECIST v1.1 criteria. Subjects will be randomized in a 2:1 ratio to either Oraxol or IV paclitaxel (as Taxol or generic). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02594371
Study type Interventional
Source Athenex, Inc.
Contact
Status Completed
Phase Phase 3
Start date December 2, 2015
Completion date June 30, 2022
View Details
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