Clinical trial · Interventional
Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
NCT00669565CI-TRIAL-00004597completedPhase 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)
This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with 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 |
|---|---|---|---|
| Carcinoma Breast Stage IV | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bavituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary objective of this study is to determine the overall response rate (CR+PR)
- timeFrame
- Until disease progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Living in India for the duration of the study * Adult females over age 18 years of age with a life expectancy of at least 3 months * Confirmed breast cancer with evidence of locally advanced or metastatic disease * Disease that is measurable by radiology imaging * Ambulatory and capable of all selfcare but unable to carry out any work activities. * Adequate laboratory results (hematologic, renal, hepatic) * Negative pregnancy test Exclusion Criteria: * History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia) * Any history of thromboembolic events (clots within blood vessels) * Ongoing treatment with high doses of anticoagulants * Use of hormone therapy * Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) * Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy * Radiotherapy within 2 weeks entering the study * Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study * Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine) * Diagnosed and active CNS disease or metastatic lesions * Major surgery within 4 weeks of starting the study * Pregnant or nursing * Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease) * History of heart disease * History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids * Diagnosed with HIV or hepatitis
References
Publications (0)
Data not yet available
No reference posted for this study.