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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00669591

Enrollment

Registered

2008-04-30

Start date

2008-01-31

Completion date

2010-08-31

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, docetaxel chemotherapy, bavituximab, monoclonal antibody

Brief summary

The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer

Interventions

DRUGBavituximab

Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer	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

Measure	Time frame
Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.	Approximately 1 year

Countries

Georgia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026