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

Association Européenne de Recherche en Oncologie

Status and phase: Completed; Phase 2

Conditions: Node Positive Breast Cancer

Treatments: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00189670

AERO-B03

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)