A Phase II Study of Abraxane® and Carboplatin as First-line Treatment for "Triple Negative" (Demonstrating no Expression for Estrogen, Progesterone, or Human Epidermal Growth Factor Receptor 2 (HER2)Receptors) Metastatic Breast Cancer
Paclitaxel and cisplatin are well-recognized for their activity in treating a variety of
tumors including breast cancer. As cytotoxins, they have been studied alone and in
combination with other chemotherapeutic agents, and have been incorporated into treatment
regimens for women who fail previous anthracycline-based therapies. Although both agents
are notable for favorable response rates, they are also associated with a variety of adverse
events, some of which may be dose-limiting and having a negative effect on quality of life:
myelosuppression, nausea and vomiting, diarrhea, stomatitis/mucositis, short- and long-term
neuropathy, nephrotoxicity, alopecia and hypersensitivity reactions.
As second-generation compounds, Abraxane® and carboplatin have been shown to improve
response rates and may mediate some of the toxicities associated with paclitaxel and
cisplatin, respectively. Of particular interest is Abraxane's potential to reduce allergic
reactions associated with other taxanes.
This study combines these two agents: primarily, to evaluate progression-free survival; and
secondarily, to assess the feasibility and tolerability of this regimen to treat poor
prognosis metastatic breast cancer patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.
PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first
Kimberly L Blackwell, MD
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|