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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: PS-341, doxorubicin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled subjects with metastatic breast cancer from the Wisconsin Oncology Network (WON), which is driven by investigators at the University of Wisconsin Carbone Cancer Center, from August of 2006 through February of 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bortezomib and Doxorubicin Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.

Participant Flow:   Overall Study
    Bortezomib and Doxorubicin
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bortezomib and Doxorubicin Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.

Baseline Measures
   Bortezomib and Doxorubicin 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3  75.0% 
>=65 years      1  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      2  50.0% 
Unknown or Not Reported      2  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      4 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   4 


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: Every two cycles/42 days, up to 7 months ]

2.  Secondary:   Time to Progression   [ Time Frame: Up to one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Anne Traynor
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-262-5092
e-mail: amt@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00574236     History of Changes
Other Study ID Numbers: 2004-0130
CO04101
First Submitted: December 13, 2007
First Posted: December 17, 2007
Results First Submitted: March 21, 2018
Results First Posted: April 20, 2018
Last Update Posted: May 23, 2018