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Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00303108
Recruitment Status : Completed
First Posted : March 15, 2006
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Collaborators:
Ortho Biotech, Inc.
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
US Oncology Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Pegylated liposomal doxorubicin
Drug: Carboplatin
Drug: trastuzumab
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D+C and Taxane Naive D+C and Taxane Pretreated D+C+H
Hide Arm/Group Description Doxil, Carboplatin and Taxane naive Doxil, Carboplatin and Taxane pretreated Doxil, Carboplatin, and Herceptin
Period Title: Overall Study
Started 43 46 47
Completed 31 37 31
Not Completed 12 9 16
Reason Not Completed
Adverse Event             5             6             7
Patient Request             4             2             8
Failed Entry             1             0             1
ineligible             2             1             0
Arm/Group Title D+C and Taxane Naive D+C and Taxane Pretreated D+C+H Total
Hide Arm/Group Description Doxil, Carboplatin and Taxane naive Doxil, Carboplatin and Taxane pretreated Doxil, Carboplatin, and Herceptin Total of all reporting groups
Overall Number of Baseline Participants 43 46 47 136
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants 46 participants 47 participants 136 participants
61.0
(28.0 to 84.9)
51.7
(29.8 to 72.3)
54.1
(29.0 to 77.6)
56.4
(28.0 to 84.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 47 participants 136 participants
Female
42
  97.7%
46
 100.0%
47
 100.0%
135
  99.3%
Male
1
   2.3%
0
   0.0%
0
   0.0%
1
   0.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 47 participants 136 participants
Caucasian 30 34 37 101
Black 10 8 7 25
Hispanic 3 4 2 9
Hawaiian 0 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 46 participants 47 participants 136 participants
43 46 47 136
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.
Time Frame From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title D+C and Taxane Naive D+C and Taxane Pretreated D+C+H
Hide Arm/Group Description:
Doxil, Carboplatin and Taxane naive
Doxil, Carboplatin and Taxane pretreated
Doxil, Carboplatin, and Herceptin
Overall Number of Participants Analyzed 39 42 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.8
(17.0 to 47.6)
31.0
(17.6 to 47.1)
55.6
(40.0 to 70.4)
2.Secondary Outcome
Title Duration of Response
Hide Description Duration from date of stating treatment to the date of first CR or PR.
Time Frame From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieved CR or PR.
Arm/Group Title D+C and Taxane Naive D+C and Taxane Pretreated D+C+H
Hide Arm/Group Description:
Doxil, Carboplatin and Taxane naive
Doxil, Carboplatin and Taxane pretreated
Doxil, Carboplatin, and Herceptin
Overall Number of Participants Analyzed 12 13 25
Median (Full Range)
Unit of Measure: months
11.1
(0.9 to 15.2)
7.0
(2.8 to 13.2)
11.8
(2.3 to 16.8)
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of “non-target” lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel.

Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title D+C and Taxane Naive D+C and Taxane Pretreated D+C+H
Hide Arm/Group Description:
Doxil, Carboplatin and Taxane naive
Doxil, Carboplatin and Taxane pretreated
Doxil, Carboplatin, and Herceptin
Overall Number of Participants Analyzed 43 46 47
Median (Full Range)
Unit of Measure: months
8.1
(0.3 to 28.5)
5.4
(0.1 to 21.0)
10.1
(0.2 to 18.5)
4.Secondary Outcome
Title 1-year Overall Survival
Hide Description OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title D+C and Taxane Naive D+C and Taxane Pretreated D+C+H
Hide Arm/Group Description:
Doxil, Carboplatin and Taxane naive
Doxil, Carboplatin and Taxane pretreated
Doxil, Carboplatin, and Herceptin
Overall Number of Participants Analyzed 43 46 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of overall survival
0.83
(0.67 to 0.915)
0.56
(0.40 to 0.69)
0.90
(0.76 to 0.96)
Time Frame During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D+C and Taxane Naive or Pretreated D+C+H
Hide Arm/Group Description Doxil, Carboplatin and Taxane naive or pretreated. Doxil, Carboplatin, and Herceptin
All-Cause Mortality
D+C and Taxane Naive or Pretreated D+C+H
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D+C and Taxane Naive or Pretreated D+C+H
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/83 (9.64%)      3/46 (6.52%)    
Blood and lymphatic system disorders     
ANEMIA  1  1/83 (1.20%)  1 0/46 (0.00%)  0
PANCYTOPENIA  1  1/83 (1.20%)  2 0/46 (0.00%)  0
THROMBOCYTOPENIA  1  2/83 (2.41%)  2 0/46 (0.00%)  0
Gastrointestinal disorders     
ANOREXIA  1  1/83 (1.20%)  1 0/46 (0.00%)  0
DEHYDRATION  1  2/83 (2.41%)  3 0/46 (0.00%)  0
NAUSEA AND VOMITING  1  0/83 (0.00%)  0 2/46 (4.35%)  2
VOMITING  1  1/83 (1.20%)  1 1/46 (2.17%)  1
Renal and urinary disorders     
RENAL FAILURE ACUTE  1  1/83 (1.20%)  1 0/46 (0.00%)  0
URINARY TRACT INFECTION  1  1/83 (1.20%)  1 0/46 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
PNEUMONIA  1  0/83 (0.00%)  0 1/46 (2.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
D+C and Taxane Naive or Pretreated D+C+H
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/83 (96.39%)      44/46 (95.65%)    
Blood and lymphatic system disorders     
ANEMIA  1  48/83 (57.83%)  152 30/46 (65.22%)  90
EDEMA  1  7/83 (8.43%)  7 4/46 (8.70%)  11
LEUCOPENIA  1  21/83 (25.30%)  64 18/46 (39.13%)  75
NEUTROPENIA  1  40/83 (48.19%)  177 26/46 (56.52%)  145
THROMBOCYTOPENIA  1  35/83 (42.17%)  139 14/46 (30.43%)  82
Gastrointestinal disorders     
ANOREXIA  1  12/83 (14.46%)  14 11/46 (23.91%)  11
CONSTIPATION  1  20/83 (24.10%)  24 8/46 (17.39%)  8
DEHYDRATION  1  1/83 (1.20%)  1 3/46 (6.52%)  3
DIARRHEA  1  12/83 (14.46%)  16 9/46 (19.57%)  15
DYSPEPSIA  1  1/83 (1.20%)  1 3/46 (6.52%)  3
NAUSEA  1  43/83 (51.81%)  88 29/46 (63.04%)  44
STOMATITIS  1  5/83 (6.02%)  7 1/46 (2.17%)  1
VOMITING  1  16/83 (19.28%)  27 12/46 (26.09%)  14
General disorders     
FEVER  1  3/83 (3.61%)  3 4/46 (8.70%)  5
INSOMNIA  1  6/83 (7.23%)  6 3/46 (6.52%)  3
WEAKNESS  1  40/83 (48.19%)  85 23/46 (50.00%)  41
Immune system disorders     
ALLERGIC REACTION  1  5/83 (6.02%)  6 2/46 (4.35%)  2
Infections and infestations     
MUCOSITIS  1  6/83 (7.23%)  11 10/46 (21.74%)  20
Metabolism and nutrition disorders     
HYPERGLYCEMIA  1  1/83 (1.20%)  2 4/46 (8.70%)  7
HYPOKALEMIA  1  1/83 (1.20%)  4 3/46 (6.52%)  3
Musculoskeletal and connective tissue disorders     
MUSCLE WEAKNESS  1  6/83 (7.23%)  8 3/46 (6.52%)  5
MYALGIA  1  3/83 (3.61%)  4 6/46 (13.04%)  6
PAIN BONE  1  1/83 (1.20%)  1 5/46 (10.87%)  5
Nervous system disorders     
DIZZINESS  1  5/83 (6.02%)  7 1/46 (2.17%)  1
NEUROPATHY  1  4/83 (4.82%)  4 4/46 (8.70%)  5
Respiratory, thoracic and mediastinal disorders     
SHORTNESS OF BREATH  1  4/83 (4.82%)  5 4/46 (8.70%)  4
Skin and subcutaneous tissue disorders     
ALOPECIA  1  11/83 (13.25%)  11 15/46 (32.61%)  17
DRY SKIN  1  3/83 (3.61%)  3 3/46 (6.52%)  4
FLUSHING  1  1/83 (1.20%)  1 3/46 (6.52%)  3
HAND-FOOT SYNDROME  1  8/83 (9.64%)  15 7/46 (15.22%)  10
NAIL DISORDER  1  2/83 (2.41%)  2 4/46 (8.70%)  6
RASH  1  8/83 (9.64%)  10 9/46 (19.57%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE v3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rufus Collea
Organization: New York Oncology Hematology, Albany Medical Center
Phone: 518-262-6696
EMail: rufus.collea@usoncology.com
Layout table for additonal information
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00303108     History of Changes
Other Study ID Numbers: 04111
First Submitted: March 13, 2006
First Posted: March 15, 2006
Results First Submitted: February 2, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016