Carcinoma Breast Stage IV
Conditions
Keywords
Locally Advanced or Metastatic Breast Cancer
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.
Interventions
DRUGBavituximab
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.
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the overall response rate (CR+PR) | Until disease progression |
Countries
India
Outcome results
None listed