Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer

NCT00189670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2005-09-19

No results posted yet for this study

Summary

To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.

Conditions

  • Node Positive Breast Cancer

Interventions

PROCEDURE

6 TEC q 3 weeks

PROCEDURE

4 EC q 2 weeks followed by 4 TXT q 2 weeks

PROCEDURE

4 TXT q 2 weeks followed by 4 EC q 2 weeks

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY
  • Amgen

    collaborator INDUSTRY
  • Association Européenne de Recherche en Oncologie

    lead OTHER

Principal Investigators

  • Pascal Piedbois, MD, PhD · Association Europeenne de Recherche en Oncologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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Entities

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 NCT00189670 on ClinicalTrials.gov