A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST [Version 1.1])
4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized
No
Andrew D Seidman, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
TOB206
NCT01609127
May 2012
July 2014
Name | Location |
---|---|
The West Clinic | Memphis, Tennessee 38120 |