Last updated on February 2019

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

Brief description of study

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

Detailed Study 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).

Clinical Study Identifier: NCT02594371

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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