The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC). The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.
During the screening stage, participants will be required to have a diagnostic computed tomography (CT) scan with etarfolatide (EC20) to identify target lesions and determine eligibility for treatment. After successful screening, during the treatment stage, participants will receive study drug (vintafolide, vintafolide + paclitaxel, or paclitaxel) for approximately four 28-day cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
During treatment, participants receive IV vintafolide 2.5 mg.
During treatment, participants receive IV paclitaxel 80 mg/m\^2.
During screening and prior to screening CT scan, participants receive an IV injection of 0.1 mg etarfolatide radiolabeled with 20 to 25 milliCuries of technetium-99m.
Progression Free Survival (PFS)
Time frame: Up to 60 months
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Time frame: Up to 60 months
Clinical Benefit Rate (CR + PR + Stable Disease [SD] for >=6 months)
Time frame: Up to 60 months
Overall Survival (OS)
Time frame: Up to 60 months
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During screening and prior to etarfolatide injection and screening CT scan, participants receive an IV injection of 0.5 mg folic acid.
During treatment, participants receive dexamethasone 20 mg orally 12 to 6 hours prior to paclitaxel; OR promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel; OR cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel.