NCT00386685

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

2.3 years

First QC Date

October 10, 2006

Last Update Submit

April 11, 2011

Conditions

Breast Neoplasms

Keywords

CancerBreastmetastatic breast cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate (best overall response under treatment)

    study period

Secondary Outcomes (1)

  • Incidence of grade 3-4 toxicities, pharmacokinetic interaction

    study period

Interventions

larotaxel (XRP9881)DRUG

intravenous administration

trastuzumabDRUG

intravenous administration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Bromma, Sweden

Location

Sanofi-Aventis Administrative Office

Geneva, Switzerland

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

larotaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Henri Roche, PhD

    Institut Claudius Regaud - Toulouse - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2008

Study Completion

January 1, 2011

Last Updated

April 12, 2011

Record last verified: 2011-04

Locations

SE(1)FR(1)BE(1)CH(1)