Clinical trial · Interventional
Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer
A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer
NCT00536939CI-TRIAL-00047305terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study has been terminated due to slow enrollment
Summary
Brief summary (as posted)
The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Enzastaurin | Drug | Enzastaurin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzastaurin + Bevacizumab + Paclitaxel
- description
- Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression. Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).
- interventionNames
- Drug: Enzastaurin
- Drug: Bevacizumab
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- Bevacizumab + Paclitaxel + Placebo
- description
- Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
- interventionNames
- Drug: Bevacizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have signed an inform consent document * Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease * Have not received any prior chemotherapy for locally recurrent or metastatic disease * Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment * Age 18 years or older at time of informed consent Exclusion Criteria: * Have any clinical evidence of central nervous system (CNS) metastases * Have a history of seizure * Have had a major surgical procedure within 4 weeks prior to assignment to study treatment * Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment * Have symptomatic peripheral vascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.