Clinical trial · Interventional
Docetaxel in Node Positive Adjuvant Breast Cancer
A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.
NCT00688740CI-TRIAL-00004424TAX316completedPhase 3Results postedClinicalTrials.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)
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.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAC (Docetaxel)
- description
- docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment
- interventionNames
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- FAC (5-fluorouracil)
- description
- 5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment
- interventionNames
- Drug: 5-fluorouracil
- Drug: Doxorubicin
- Drug: Cyclophosphamide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTMartin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681. PMID 15930421
- DERIVEDGarcia-Saenz JA, Spera G, Pollan M, Bermejo B, Ruiz-Borrego M, Chan A, Martin M, Guerrero-Zotano A, Calvo L, Rodriguez-Lescure A, Marin M, Chap L, Crown J, Pienkowski T, Bee V, Casas M, Polonio O, Bezares S, Slamon D. Body mass index as a predictive factor for efficacy of adjuvant taxane-based chemotherapy in early-stage breast cancer patients: A pooled analysis from adjuvant GEICAM Spanish Breast Cancer Group and TRIO Translational Research in Oncology Group studies. Int J Cancer. 2025 Aug 15;157(4):709-721. doi: 10.1002/ijc.35432. Epub 2025 Apr 10. PMID 40207789
- DERIVEDMackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodriguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houe V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12. PMID 23246022