Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00574236|
Recruitment Status : Terminated (no additional funding)
First Posted : December 17, 2007
Results First Posted : April 20, 2018
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: PS-341, doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer|
|Actual Study Start Date :||August 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Drug: PS-341, doxorubicin
bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
- Overall Response Rate [ Time Frame: Every two cycles/42 days, up to 7 months ]
Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
- Time to Progression [ Time Frame: Up to one year ]Number of days to progression, where progression is defined as the number of days from the day of first study drug administration to the day the patient experiences an event of disease progression, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. If a patient has not experienced an event of disease progression, then the patient's data will be censored at the date of the last available evaluation. Progression-free survival will be summarized by medium time to progression.
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): NCT00574236
|United States, Wisconsin|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||James A Stewart, M.D.||University of Wisconsin PPC Comprehensive Cancer Center|