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XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00386685
First received: October 10, 2006
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate (best overall response under treatment) [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of grade 3-4 toxicities, pharmacokinetic interaction [ Time Frame: study period ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00386685     History of Changes
Other Study ID Numbers: TCD6595, XRP9881
Study First Received: October 10, 2006
Last Updated: April 11, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Sweden: Medical Products Agency

Keywords provided by Sanofi:
Cancer
Breast
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013