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

Phase 2

Completed

• Conditions: Node Positive Breast Cancer

• Registration Number: NCT00189670
• Lead Sponsor: Association Européenne de Recherche en Oncologie

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-19
• Last Update Posted: 2005-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL