Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669565
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : March 24, 2011
Information provided by:
Peregrine Pharmaceuticals

April 28, 2008
April 30, 2008
March 24, 2011
July 2008
July 2010   (Final data collection date for primary outcome measure)
The primary objective of this study is to determine the overall response rate (CR+PR) [ Time Frame: Until disease progression ]
Same as current
Complete list of historical versions of study NCT00669565 on Archive Site
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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
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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma Breast Stage IV
Drug: Bavituximab
Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
PPHM 0702
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A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine Pharmaceuticals Inc.
Peregrine Pharmaceuticals
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Peregrine Pharmaceuticals
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP