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XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

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. Identifier: NCT00386685
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : April 12, 2011
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Neoplasms Drug: larotaxel (XRP9881) Drug: trastuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
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)
Study Start Date : July 2006
Primary Completion Date : October 2008
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Intervention Details:
    Drug: larotaxel (XRP9881)
    intravenous administration
    Drug: trastuzumab
    intravenous administration

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00386685

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

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00386685     History of Changes
Other Study ID Numbers: TCD6595
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by Sanofi:
metastatic breast cancer

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