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

Phase 2

• Conditions: Locally Advanced Non-resectable Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: Tesetaxel; Drug: Capecitabine

• Registration Number: NCT01609127
• Lead Sponsor: Genta Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-05
• Study Start: 2012-05
• Study First Submitted: 2012-05-25
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01
• Primary Completion: 2013-09
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tesetaxel every 3 weeks	Tesetaxel	Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle
Tesetaxel weekly	Tesetaxel	Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 in a 28-day cycle
Capecitabine	Capecitabine	Capecitabine 1250 mg/m2 orally twice daily (equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 in a 21-day cycle

Primary Outcome Measures

Name	Time	Method
Response rate	4 months after the date of randomization of the last patient, which is estimated will occur 16 months after the first patient is randomized	the percentage of patients with a confirmed complete or partial response, as defined in the revised Response Evaluation Criteria in Solid Tumors (revised RECIST \[Version 1.1\])

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized	the period from the date of randomization to the date when disease progression is first documented or when the patient dies within 6 weeks of the last lesion assessment
Progression-free survival rate	6 and 12 months after patients' date of randomization	the percentage of patients who are progression free
Clinical benefit rate	12 months after the date of randomization of the last patient, which is estimated will occur 24 months after the first patient is randomized	the percentage of patients with a complete or partial response of any duration or stable disease lasting ≥ 6 months
Adverse events	up to 30 days after patients' last dose of study medication	the percentage of patients with adverse events classified by term and body system

Trial Locations

Locations (1)

The West Clinic; 🇺🇸 Memphis, Tennessee, United States