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

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Amgen
Information provided by:
Association Européenne de Recherche en Oncologie
ClinicalTrials.gov Identifier:
NCT00189670
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00189670     History of Changes
Other Study ID Numbers: AERO-B03
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 20, 2014