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XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386685
First Posted: October 11, 2006
Last Update Posted: April 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.

The secondary objectives are safety and pharmacokinetic interaction


Condition Intervention Phase
Breast Neoplasms Drug: larotaxel (XRP9881) Drug: trastuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate (best overall response under treatment) [ Time Frame: study period ]

Secondary Outcome Measures:
  • Incidence of grade 3-4 toxicities, pharmacokinetic interaction [ Time Frame: study period ]

Enrollment: 51
Study Start Date: July 2006
Study Completion Date: January 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: larotaxel (XRP9881)
    intravenous administration
    Drug: trastuzumab
    intravenous administration
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic breast cancer (MBC)
  • HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
  • Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
  • Adequate organs functions

Exclusion Criteria:

  • More than one previous chemotherapy regimen for metastatic disease
  • Cardiac dysfunction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386685


Locations
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
France
Sanofi-Aventis Administrative Office
Paris, France
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Henri Roche, PhD Institut Claudius Regaud - Toulouse - France
  More Information

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00386685     History of Changes
Other Study ID Numbers: TCD6595
XRP9881
First Submitted: October 10, 2006
First Posted: October 11, 2006
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by Sanofi:
Cancer
Breast
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents