Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer (ABC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00479674|
Recruitment Status : Completed
First Posted : May 28, 2007
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Abraxane Drug: Bevacizumab Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) Metastatic Breast Cancer|
|Study Start Date :||May 2007|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Experimental: Abraxane, Carboplatin, Bevacizumab
Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15
100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
Other Name: nanoparticle albumin-bound paclitaxelDrug: Bevacizumab
10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
Other Name: AvastinDrug: Carboplatin
area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.
- Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer. [ Time Frame: 5 years ]Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.
- Median Proportion Progression-free as Estimated by Kaplan-Meier Methods [ Time Frame: 5 years ]PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.
- To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers [ Time Frame: 18 months ]
- to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy [ Time Frame: 18 months ]
- to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS) [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479674
|United States, North Carolina|
|Presbyterian Health Care|
|Charlotte, North Carolina, United States, 28204|
|Northeast Oncology Associates|
|Concord, North Carolina, United States, 28205|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Forsyth Regional Cancer Center|
|Winston-Salem, North Carolina, United States, 27103-3019|
|Principal Investigator:||Kimberly Blackwell, MD||Duke University|