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

Node Positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189670
• Other study ID #: AERO-B03
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005

Study information

• Verified date: September 2005
• Source: Association Européenne de Recherche en Oncologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Node Positive Breast Cancer

Intervention

Procedure:
• 6 TEC q 3 weeks

• 4 EC q 2 weeks followed by 4 TXT q 2 weeks

• 4 TXT q 2 weeks followed by 4 EC q 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Association Européenne de Recherche en Oncologie	Amgen, Aventis Pharmaceuticals