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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189670
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aventis Pharmaceuticals
Amgen
Information provided by:
Association Européenne de Recherche en Oncologie
  Purpose
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:

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189670


Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Aventis Pharmaceuticals
Amgen
Investigators
Principal Investigator: Pascal Piedbois, MD, PhD Association Europeenne de Recherche en Oncologie
  More Information

ClinicalTrials.gov Identifier: NCT00189670     History of Changes
Other Study ID Numbers: AERO-B03
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases