Clinical trial · Interventional
A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer
NCT00669591CI-TRIAL-00027106completedPhase 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 the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced 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 |
|---|---|---|---|
| Bavituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression
- interventionNames
- Drug: Bavituximab
Primary outcomes (1)
- measure
- Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
- timeFrame
- Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year.
Secondary outcomes (1)
- measure
- Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult females over age 18 with life expectancy of at least 3 months * Histologically or cytologically confirmed locally advanced or metastatic breast cancer * One and only one prior chemotherapy regimen (no prior docetaxel) * Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT) * Adequate hematologic, renal, and hepatic function; Exclusion Criteria: * Known history of bleeding diathesis or coagulopathy * Any current evidence of clinically significant bleeding * Any history of thromboembolic events * Concurrent hormone therapy * Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.