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

NCT00189670 | Completed Phase 2

• 1 other identifier: AERO-B03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

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 PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Européenne de Recherche en Oncologie: lead
• Aventis Pharmaceuticals: collaborator
• Amgen: collaborator

Study Officials

• Pascal Piedbois, MD, PhD

  Association Europeenne de Recherche en Oncologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Last Updated: September 19, 2005

Record last verified: 2005-09