Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to progression without producing intolerable toxicity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- PFS [ Time Frame: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first ] [ Designated as safety issue: No ]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.
- To assess the safety and tolerability of a combination regimen of weekly Abraxane® and carboplatin to treat women with "triple negative" Stage IV metastatic breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Abraxane, Carboplatin
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Other Name: paclitaxel protein-bound particles for injectable suspensionDrug: Carboplatin
area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
Other Name: Paraplatin
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.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Peking University School of Oncology/Beijing Cancer Hospital|
|Beijing, China, 100142|
|Study Chair:||Kimberly L Blackwell, MD||Duke University|