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

PHASE2UnknownINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

July 31, 2014

Conditions
Locally Advanced Non-resectable Breast CancerMetastatic Breast Cancer
Interventions
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

Trial Locations (1)

38120

RECRUITING

The West Clinic, Memphis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genta Incorporated

INDUSTRY