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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00189670
Enrollment
Unknown
Registered
2005-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2005-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Node Positive Breast Cancer

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.

Interventions

PROCEDURE6 TEC q 3 weeks
PROCEDURE4 EC q 2 weeks followed by 4 TXT q 2 weeks
PROCEDURE4 TXT q 2 weeks followed by 4 EC q 2 weeks

Sponsors

Aventis Pharmaceuticals
CollaboratorINDUSTRY
Amgen
CollaboratorINDUSTRY
Association Européenne de Recherche en Oncologie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026