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

This study has been completed.
Aventis Pharmaceuticals
Information provided by:
Association Européenne de Recherche en Oncologie Identifier:
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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.

Condition Intervention Phase
Node Positive Breast Cancer 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 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer

Resource links provided by NLM:

Further study details as provided by Association Européenne de Recherche en Oncologie:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female

Inclusion Criteria:

  • Patient with histologically proven breast cancer
  • Surgical resection performed with clear margins (R0 resection)
  • At least 1 histologically proven involved axillary node
  • ER + or ER-
  • Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
  • Aged over 18 years, and more than 10-year life expectancy
  • ECOG performance status 0-1
  • Signed informed consent form prior to randomization

Exclusion Criteria:

  • Bilateral breast cancer
  • Inflammatory breast cancer
  • Personal history of breast cancer
  • Immunohistochemical only node involvement
  • Intraductal breast cancer
  • Distant metastases
  • Contraindication to any drug contained in the chemotherapy regimens
  • Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease
  • Poor renal function (creatinin level > 120 micromol/L), poor hepatic function (total bilirubin level > 1 UNL), transaminases > 2.5 UNL)
  • Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L; Hemoglobin < 10 G/dL
  • Poor contractile cardiac function (LVEF < 50%)
  • Coronary disease
  • Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma
  • Pregnancy or breast feeding
  • Absence of contraception in non menopausal women
  • Adult patient unable to give informed consent because of intellectual impairment
  • Concomitant participation to another trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT00189670

Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Aventis Pharmaceuticals
Principal Investigator: Pascal Piedbois, MD, PhD Association Europeenne de Recherche en Oncologie
  More Information Identifier: NCT00189670     History of Changes
Other Study ID Numbers: AERO-B03
Study First Received: September 12, 2005
Last Updated: September 12, 2005

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 19, 2017