Clinical trial · Interventional
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
NCT00189670CI-TRIAL-00000163completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Node Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4 EC q 2 weeks followed by 4 TXT q 2 weeks | Procedure | — | UNRESOLVED |
| 4 TXT q 2 weeks followed by 4 EC q 2 weeks | Procedure | — | UNRESOLVED |
| 6 TEC q 3 weeks | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.