Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
Phase 2
Completed
- Conditions
- Carcinoma Breast Stage IV
- Registration Number
- NCT00669565
- Lead Sponsor
- Peregrine Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine the overall response rate (CR+PR) Until disease progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Rajalakshmi Multispecialty Hospital
🇮🇳Bangalore, India
Apollo Specialty Hospitals
🇮🇳Chennai, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabaad, India
Regional Cancer Center
🇮🇳Kerala, India
Bangalore Institute of Oncology
🇮🇳Banglore, India
Medical College Hospital
🇮🇳Kolkata, India
Bharath Hospital and Institite of Oncology
🇮🇳Mysore, India
Curie Manavata Cancer Center
🇮🇳Nashik, India
Ruby Hall Clinic
🇮🇳Pune, India