Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01207102|
Recruitment Status : Terminated (Low enrollment and there is insufficient data to publish.)
First Posted : September 22, 2010
Results First Posted : December 15, 2014
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Abraxane Drug: Carboplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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 suspension
area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
Other Name: Paraplatin
- PFS [ Time Frame: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207102
|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|