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Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

NCT00485979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2011-06-28

No results posted yet for this study

Summary

The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).

The secondary objectives are:

* to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
* to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.

Conditions

  • Breast Neoplasms

Interventions

DRUG

larotaxel (XRP9881)

intravenous administration

DRUG

docetaxel

intravenous administration

DRUG

trastuzumab

intravenous administration

Sponsors & Collaborators

Principal Investigators

  • Michel Marty, MD · Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Belgium
  • Brazil
  • France
  • Germany
  • Poland
  • Tunisia
  • United Kingdom
  • Uruguay

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00485979 on ClinicalTrials.gov