Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Advanced Breast Cancer; Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: larotaxel (XRP9881); Drug: trastuzumab

• Registration Number: NCT00387907
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-06
• Disposition First Submitted QC: 2016-04-06
• Last Update Submitted: 2016-04-06
• Disposition First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• Diagnosis of breast cancer
• Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
• No more than one prior treatment for advanced disease
• Her2 positive status
• Adequate liver and kidney function
• No remaining severe harmful effects to prior treatments

Exclusion Criteria

• Certain heart condition
• Pregnant Women
• History of another cancer except some skin cancers and cervical cancer
• Taking other treatments for your cancer at the time you enter the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Larotaxel + Trastuzumab	trastuzumab	-
Larotaxel + Trastuzumab	larotaxel (XRP9881)	-

Primary Outcome Measures

Name	Time	Method
Tumor response measured	every 2 cycles during treatment phase

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival and Overall Survival	measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Malvern, Pennsylvania, United States