NCT01609127

Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.

Conditions

• Locally Advanced Non-resectable Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Tesetaxel	Tesetaxel 27 mg/m2 orally once on Day 1 of each 21-day cycle
DRUG	Tesetaxel	Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 of each 28-day cycle
DRUG	Capecitabine	Capecitabine 1250 mg/m2 orally twice daily (in the morning and evening after a meal; equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 of each 21-day cycle

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-09-01
• Completion: 2014-07-01
• First posted: 2012-05-31
• Last updated: 2012-06-01

Locations

1 site across 1 country: United States