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Completed

NCT Number: NCT00669591

A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

JSC. National Cancer Centre, Lisi Lake, K'alak'i T'bilisi, Georgia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bavituximab

Drug

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.

Primary outcomes

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

    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.

Secondary outcomes

  1. Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.

    Time frame: Approximately 1 year

Sponsors and collaborators

Lead sponsor

Peregrine Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2008
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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