Clinical trial · Interventional
Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer
Docetaxel-epirubicin Plus Bevacizumab as First Line Therapy for Patients With Metastatic and HER2 Negative Breast Cancer. A Multicenter Phase I-II Study
NCT00705315CI-TRIAL-00003819completedPhase 1 / Phase 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 evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.
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 |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Bevacizumab-\>Epirubicin-\>Docetaxel
- interventionNames
- Drug: Docetaxel
- Drug: Epirubicin
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (3)
- measure
- Toxicity assessment
- timeFrame
- Toxicity assessment on each cycle
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed metastatic breast adenocarcinoma * No HER2 overexpression or gene amplification * No previous therapy for metastatic breast cancer is allowed * Age 18-75 years * At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines * Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * Performance status (WHO) 0-2 * Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the UNL in the presence of liver metastases) * Adequate renal function (serum creatinine \<1.5 times the upper normal limit * Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) * Written informed consent Exclusion Criteria: * Active infection * Brain metastases * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * History of stroke * Anticoagulation therapy (except of low dose aspirin \<325mg) * Other invasive malignancy except nonmelanoma skin cancer * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women
References
Publications (1)
- DERIVEDTryfonidis K, Boukovinas I, Xenidis N, Christophyllakis C, Papakotoulas P, Politaki E, Malamos N, Polyzos A, Kakolyris S, Georgoulias V, Mavroudis D; Hellenic Oncology Research Group. A multicenter phase I-II study of docetaxel plus epirubicin plus bevacizumab as first-line treatment in women with HER2-negative metastatic breast cancer. Breast. 2013 Dec;22(6):1171-7. doi: 10.1016/j.breast.2013.08.017. Epub 2013 Oct 1. PMID 24091128