A Phase II Study of Carboplatin, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Avastin as the First Line Therapy in Metastatic Breast Cancer.
- To determine the progression-free survival of patients with locally recurrent or
metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized
nanoparticle formulation, and bevacizumab as first-line therapy.
- To determine the response rate in these patients.
- To determine the overall survival of these patients.
- To evaluate the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and
43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30
minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by IHC for
various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in
tumor-associated endothelial cells are correlated with response in both estrogen- and
progesterone-positive and negative tumors, and independently of p53 status.
After completion of study treatment, patients are followed for up to 2 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment will continue until disease progression.
Shelly Lo, MD
United States: Food and Drug Administration
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Maywood, Illinois 60153-5500|
|Swedish-American Regional Cancer Center||Rockford, Illinois 61104-2315|
|Edward Hospital Cancer Center||Naperville, Illinois 60540|
|Delnor Community Hospital - Geneva||Geneva, Illinois 60134|
|Central Dupage Cancer Center||Warrenville, Illinois 60555|
|Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital||Downers Grove, Illinois 60515-1500|