Clinical trial · Interventional
Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
NCT01150513CI-TRIAL-00049939completedPhase 2 / Phase 3ClinicalTrials.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)
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EC-T | Drug | — | UNRESOLVED |
| TP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EC-T
- interventionNames
- Drug: EC-T
- type
- EXPERIMENTAL
- label
- TP
- interventionNames
- Drug: TP
Primary outcomes (1)
- measure
- Disease Free Survival (DFS) of 3 years
- timeFrame
- 3 years after mastectomy
- description
- local recurrence, distant metastasis, the secondary primary malignancy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Triple-negative breast cancer * Older than 18 years old * Have tumor resection surgery * Sufficient organ function (marrow, heart, liver) Exclusion Criteria: * Other malignancy * Other serious disease( marrow, heart, liver)
References
Publications (2)
- DERIVEDChen Y, Wang X, Du F, Yue J, Si Y, Zhao X, Cui L, Zhang B, Bei T, Xu B, Yuan P. Association between homologous recombination deficiency and outcomes with platinum and platinum-free chemotherapy in patients with triple-negative breast cancer. Cancer Biol Med. 2023 Mar 2;20(2):155-68. doi: 10.20892/j.issn.2095-3941.2022.0525. PMID 36861447
- DERIVEDZheng F, Du F, Wang W, Wang Y, Li M, Zhao J, Wang X, Yue J, Wang J, Yang Z, Cai R, Ma F, Fan Y, Li Q, Zhang P, Xu B, Yuan P. Updated efficacy of adjuvant epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes in early triple-negative breast cancer in phase 2 trial: 8.1-year median follow-up. Breast Cancer Res Treat. 2022 Jan;191(1):97-105. doi: 10.1007/s10549-021-06401-6. Epub 2021 Oct 14. PMID 34648118