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CompletedNCT00386685Updated Apr 12, 2011

XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

A Phase 2 interventional study of larotaxel (XRP9881) and trastuzumab in Breast Neoplasms, sponsored by Sanofi. Completed at 4 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-12.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Breast Neoplasms

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Keywords

  • Cancer
  • Breast
  • metastatic breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 51 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • More than one previous chemotherapy regimen for metastatic disease
  • Cardiac dysfunction
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Interventions

  • Druglarotaxel (XRP9881)

    intravenous administration

  • Drugtrastuzumab

    intravenous administration

06

What researchers measure

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

07

Study locations

4 sites
  • Sanofi-Aventis Administrative Office
    Diegem, Belgium
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Bromma, Sweden
  • Sanofi-Aventis Administrative Office
    Geneva, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00386685
Lead sponsor
Sanofi
First posted
Oct 11, 2006
Start date
Jul 2006
Primary completion
Oct 2008
Completion
Jan 2011
Last update
Apr 12, 2011

Study contacts

Henri Roche, PhD
principal investigator · Institut Claudius Regaud - Toulouse - France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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