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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00387907
First received: October 12, 2006
Last updated: August 9, 2011
Last verified: August 2011
History of Changes

October 12, 2006
August 9, 2011
October 2006
March 2008   (final data collection date for primary outcome measure)
Tumor response measured [ Time Frame: every 2 cycles during treatment phase ] [ Designated as safety issue: No ]
Tumor response measured every 2 cycles during treatment phase.
Complete list of historical versions of study NCT00387907 on ClinicalTrials.gov Archive Site
Progression Free Survival and Overall Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]
Progression Free Survival and Overall Survival will be 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.
Not Provided
Not Provided
 
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Breast Cancer
  • Breast Cancer
  • Metastatic Breast Cancer
  • Drug: larotaxel (XRP9881)
    IV infusion
  • Drug: trastuzumab
    IV infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387907
TCD10037, XRP9881
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
Sanofi
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP