Clinical trial · Interventional
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes
NCT00623233CI-TRIAL-00006026completedPhase 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)
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Bevacizumab
- description
- Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity. Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
- interventionNames
- Drug: Gemcitabine
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Time
- timeFrame
- Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).
- description
- PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be female and greater than or equal to 18 yrs of age * Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease. * Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy * Participants may have received prior hormone therapy for locally recurrent or metastatic disease Exclusion Criteria: * Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification * Prior chemotherapy or targeted therapy for metastatic breast cancer * Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting * History of, or active brain mets * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study * Prior history of high blood pressure crisis * Have a serious, nonhealing wound, ulcer, or bone fracture
References
Publications (0)
Data not yet available
No reference posted for this study.