Clinical trial · Interventional
Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer
Docetaxel, Gemcitabine and Bevacizumab as Salvage Therapy for Metastatic Breast Cancer
NCT00754351CI-TRIAL-00007278completedPhase 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, gemcitabine and bevacizumab combination, administered biweekly, as salvage 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 |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Bevacizumab-\>Docetaxel-\>Gemcitabine
- interventionNames
- Drug: Bevacizumab
- Drug: Docetaxel
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- up to 6 months
Secondary outcomes (4)
- measure
- Progression Free Survival
- timeFrame
- 1 year
- measure
- Toxicity profile
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed metastatic breast adenocarcinoma * No HER2 overexpression or gene amplification * At least one previous chemotherapy regimen for metastatic breast cancer * Age ≥18 years * Performance status (WHO) 0-2 * Life expectancy of at least 12 weeks * Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm * Performance status (WHO) 0-2 * Adequate liver function (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 upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function * Written informed consent Exclusion Criteria: * Pregnant or lactating women * Progressive brain metastases according to clinical or radiological criteria * Brain metastases without prior radiation therapy * Radiation therapy within the previous 4 weeks * Previous radiation therapy to the only measurable lesion * Proteinuria ≥ 500 mgr of protein daily * Uncontrolled hypertension * Documented hemorrhagic diathesis or coagulation disorder * Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \< normal, ventricular arrhythmia, uncontrolled hypertension) * Thrombotic event within the previous 6 months * Concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents * Major surgical procedure within the previous 4 weeks * Presence of nonhealing wound or fracture * Peripheral neuropathy \> grade 2 according to the NCI CTCAE (version 3.0) * Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0) * Uncontrolled infection * Any serious, uncontrolled comorbidity on the investigator's judgment * Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer * Serious psychiatric illness
References
Publications (0)
Data not yet available
No reference posted for this study.