Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00517361|
Recruitment Status : Terminated (This study has been terminated due to poor accrual)
First Posted : August 16, 2007
Results First Posted : April 15, 2014
Last Update Posted : April 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: carboplatin Drug: bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Carboplatin and Bevacizumab (Avastin) Combination Therapy for ER Negative, PR Negative, and HER2/Neu Negative Metastatic Breast Cancer|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2012|
|Experimental: Carboplatin + Avastin||
AUC 6 in 250mL saline IV over 30 minutesDrug: bevacizumab
15mg/kg in 100mL saline IV over 60 - 90 minutes
Other Name: Avastin
- Progression Free Survival [ Time Frame: Up to 5 years ]Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- Response Rate [ Time Frame: Up to 5 years ]Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
- Duration of Response [ Time Frame: Up to 5 years ]
- Correlation of Response to BRCA1 Methylation Status [ Time Frame: Up to 5 years ]The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.
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): NCT00517361
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Rita Nanda, MD||University of Chicago|