Clinical trial · Interventional
Treatment of HER2-Positive Metastatic Breast Cancer With Herceptin and Bevacizumab (Antibodies Against HER2 and VEGF)
Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/Neu Proto-Oncogene and Vascular Endothelial Growth Factor
NCT00095706CI-TRIAL-00019204completedPhase 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)
The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab (drug), Herceptin (drug) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To establish the maximum tolerated dose (MTD) or recommended phase II dose of rhuMAb VEGF (bevacizumab) administered intravenously every 14 days to patients with HER2-amplified relapsed or metastatic breast cancer receiving concomitant Herceptin therapy
Secondary outcomes (3)
- measure
- To evaluate the clinical safety and toxicities of rhuMAb VEGF when administered in combination with Herceptin
- measure
- To characterize the pharmacokinetics of rhuMAb VEGF and Herceptin given in combination
- measure
- To evaluate the efficacy of rhuMAb VEGF plus Herceptin in terms of clinical activity when administered as an intravenous infusion, in patients with previously untreated metastatic or relapsed breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or relapsed locally advanced breast cancer * HER2-positive by FISH * No prior chemotherapy for metastatic disease * ECOG performance status 0-2 * Normal left ventricular ejection fraction * Bidimensionally measurable disease * Oxygen saturation \> 90% on room air Exclusion Criteria: * Other invasive malignancy within 5 years * More than 3 different metastatic sites * \>50% liver involvement by metastasis * Newly diagnosed untreated Stage IIIB breast cancer * Prior chemotherapy for metastatic disease * Clinically significant cardiovascular disease * History or evidence of CNS disease * Major surgery within 28 days prior to day 0 * Current or recent use of parenteral anticoagulants * WBC \< 3,000/uL * Platelet count \< 75,000/uL * Hemoglobin \< 9.0 g/dL * Total Bilirubin \> 2.0 mg/dL * AST or ALT \> 5 time upper limit of normal for subjects with documented liver metastases; \> 2.5 times upper limit of normal for subjects without evidence of liver metastases * Proteinuria (\> 1g protein/24 hours at baseline) * Prior therapy with Herceptin or rhuMAb VEGF (bevacizumab)
References
Publications (0)
Data not yet available
No reference posted for this study.