Clinical trial · Interventional
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer
- 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 combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
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 |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- DF
- interventionNames
- Drug: Docetaxel
- Drug: Epirubicin
- type
- EXPERIMENTAL
- label
- 2
- description
- DC
- interventionNames
- Drug: Capecitabine
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Compare the time to tumor progression between the two treatment arms
- timeFrame
- 1 year
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed metastatic breast adenocarcinoma. * No previous chemotherapy treatment for metastatic disease. * No previous anthracycline treatment except as adjuvant therapy at least one year before. * Age 19-75 years old * Presence of measurable disease * Performance status 0-2 (WHO) * Adequate cardiac function (LVEF \>50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina. * Adequate bone marrow(absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3), liver (bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal) and renal function (creatinine \<2mg/dl). * No previous radiotherapy to more than 25% of marrow-containing bones. * Written informed consent Exclusion Criteria: * Active brain metastases. * Psychiatric illness or social situation that would preclude study compliance * Other concurrent uncontrolled illness. * Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer. * Positive pregnancy for premenopausal women. * Concurrent antineoplastic treatment e.g. hormonal therapy
References
Publications (1)
- DERIVEDHoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. PMID 34037241