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A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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.

Safety Issue:

No

Authority:

Georgia: Ministry of Health

Study ID:

PPHM 0704

NCT ID:

NCT00669591

Start Date:

January 2008

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • breast cancer
  • docetaxel chemotherapy
  • bavituximab
  • monoclonal antibody
  • Breast Neoplasms

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