Clinical trial · Interventional
Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer
Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer
NCT00201708CI-TRIAL-00023764completedPhase 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)
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (AC) | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (Docetaxel before doxorubicin/cyclophosphamide)
- description
- Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
- interventionNames
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Cyclophosphamide (AC)
- type
- ACTIVE_COMPARATOR
- label
- Arm B (Docetaxel after doxorubicin/cyclophosphamide)
- description
- "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
- interventionNames
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Cyclophosphamide (AC)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have histologically or cytologically confirmed breast cancer * No metastatic disease * Prior lumpectomy or mastectomy * No prior chemotherapy or hormone treatments for breast cancer * Must have normal organ and marrow function. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Exclusion Criteria: * Peripheral neuropathy of grade II or higher. * History or evidence upon physical exam of CNS (central nervous system Diseases)disease. * History of unstable angina or myocardial infarction within the last six months. * Pregnant or nursing women. * Known allergies to polysorbate 80. * HIV-positive patients.
References
Publications (1)
- BACKGROUNDPuhalla S, Mrozek E, Young D, Ottman S, McVey A, Kendra K, Merriman NJ, Knapp M, Patel T, Thompson ME, Maher JF, Moore TD, Shapiro CL. Randomized phase II adjuvant trial of dose-dense docetaxel before or after doxorubicin plus cyclophosphamide in axillary node-positive breast cancer. J Clin Oncol. 2008 Apr 1;26(10):1691-7. doi: 10.1200/JCO.2007.14.3941. Epub 2008 Mar 3. PMID 18316792