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OpenTrials
Completed

NCT Number: NCT00386685

XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

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

Completed

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Larotaxel (XRP9881)

Drug

intravenous administration

Trastuzumab

Drug

intravenous administration

Primary outcomes

  1. Response rate (best overall response under treatment)

    Time frame: study period

Secondary outcomes

  1. Incidence of grade 3-4 toxicities, pharmacokinetic interaction

    Time frame: study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Oct 11, 2006
Registry last updated
Apr 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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