ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

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: 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
Enrollment 4

Recruitment Details 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  
Arm/Group Title Bortezomib and Doxorubicin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Bortezomib and Doxorubicin
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
  50.0%
Unknown or Not Reported
2
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description

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 Frame Every two cycles/42 days, up to 7 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Protocol accrued only 4 of 54 subjects, and was ultimately terminated. No data analysis was done.
Arm/Group Title Bortezomib and Doxorubicin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
1
  25.0%
Progressive Disease
3
  75.0%
2.Secondary Outcome
Title Time to Progression
Hide Description 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.
Time Frame Up to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortezomib and Doxorubicin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: days to progression
47
(41 to 210)
Time Frame Adverse event data were collected for 1 year, 9 months.
Adverse Event Reporting Description Investigators conducted continuous reviews of data and participant safety at monthly meetings, where the results of each of each participant's treatment were discussed and the discussion was documented in the minutes.
 
Arm/Group Title Bortezomib and Doxorubicin
Hide Arm/Group Description 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.
All-Cause Mortality
Bortezomib and Doxorubicin
Affected / at Risk (%)
Total   0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib and Doxorubicin
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortezomib and Doxorubicin
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  1/4 (25.00%)  2
Leukocytes (total WBC)  1  1/4 (25.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  2/4 (50.00%)  2
Gastrointestinal disorders   
Anorexia  1  2/4 (50.00%)  3
Constipation  1  4/4 (100.00%)  5
Diarrhea  1  2/4 (50.00%)  2
Heartburn/dyspepsia  1  1/4 (25.00%)  1
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  1/4 (25.00%)  2
Nausea  1  4/4 (100.00%)  6
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  3/4 (75.00%)  5
Insomnia  1  1/4 (25.00%)  1
Pain  1  4/4 (100.00%)  9
Sweating (diaphoresis)  1  1/4 (25.00%)  1
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Ungual (nails)  1  1/4 (25.00%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina  1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  1/4 (25.00%)  1
Glucose, serum-high (hyperglycemia)  1  1/4 (25.00%)  1
Nervous system disorders   
Dizziness  1  2/4 (50.00%)  2
Mood alteration: Depression  1  1/4 (25.00%)  1
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial  1  1/4 (25.00%)  1
Neuropathy: sensory  1  3/4 (75.00%)  5
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body)  1  3/4 (75.00%)  3
Nail changes  1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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
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