Clinical trial · Interventional
A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer
A Randomized Phase II Trial of Paclitaxel and Bevacizumab Versus Gemcitabine, Paclitaxel, and Bevacizumab as First Line Treatment for Locally Advanced or Metastatic Breast Cancer
NCT00320541CI-TRIAL-00011444completedPhase 2Results postedClinicalTrials.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 compare the cancer response to both treatments for locally advanced or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- paclitaxel plus bevacizumab (PB)
- description
- paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
- interventionNames
- Drug: paclitaxel
- Drug: bevacizumab
- type
- EXPERIMENTAL
- label
- paclitaxel plus bevacizumab plus gemcitabine (PB+G)
- description
- paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
- interventionNames
- Drug: gemcitabine
- Drug: paclitaxel
- Drug: bevacizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs. * Must be able to measure the disease by specific medical parameters * May have received breast cancer treatment in the early stage of the disease * May be restricted in physically strenuous activity but able to carry out light work. * Must have adequate organ function as seen in blood test results. Exclusion Criteria: * Cancer that has spread to the brain. * Unstable heart problems * Unstable high blood pressure. * Breast cancer treatment after the disease has considered to spread to other areas or organs. * Unable to agree with the requirements of the study
References
Publications (0)
Data not yet available
No reference posted for this study.