Phase 3
Completed N=1,491
Docetaxel in Node Positive Adjuvant Breast Cancer
Source: ClinicalTrials.gov NCT00688740 ↗Enrolled (actual)
1,491
Serious AEs
22.6%
Results posted
Feb 2011
Primary outcomePrimary: Number of Participants With Disease-Free Survival Events — 287; 333 Participants — p=0.0043
Summary
The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Disease-Free Survival Events |
287; 333 | 0.0043 sig |
| SECONDARY Number of Participants With Overall Survival Events |
188; 241 | 0.0020 sig |
| SECONDARY Number of Participants With Second Primary Malignancies (Toxicity) |
67; 66 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).
- Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.
Exclusion criteria
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
- Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
Data sourced from ClinicalTrials.gov (NCT00688740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.