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A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or 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: NCT00490646
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : July 18, 2012
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
R-Pharm

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: ixabepilone
Drug: docetaxel
Drug: trastuzumab
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity. trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 25 25
Treated 24 24
Completed 23 [1] 23 [2]
Not Completed 2 2
Reason Not Completed
Still on trastuzumab monotherapy             1             1
Never Treated (had an adverse event)             1             0
Never Treated (withdrew consent)             0             1
[1]
Completed=Off-treatment (Major reasons: Disease progression=14; study drug toxicity=4)
[2]
Completed=Off-treatment (Major reasons: Disease progression=13; study drug toxicity=1)
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV Total
Hide Arm/Group Description trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity. trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
52.0
(29.0 to 71.0)
53.0
(37.0 to 82.0)
52.5
(29.0 to 82.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
< 65 years 19 21 40
>=65 years 6 4 10
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 25 participants 25 participants 50 participants
25 25 50
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 25 participants 25 participants 50 participants
25 25 50
Karnofsky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
100 15 15 30
90 5 9 14
80 4 0 4
70 1 0 1
Not Reported 0 1 1
[1]
Measure Description:

Karnofsky Performance Status classifies participants according to their functional impairment. Scores range from 0-100 units on a scale; lower the score, the worse the survival for most serious illnesses.

100: Normal, no complaints. 90: Able to carry on normal activities; minor signs or symptoms of disease. 80: Normal activity with effort. 70: Cares for self. Unable to carry on normal activity or to do active work. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scores were converted to Karnofsky Performance Status Scores.

Menopausal Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Pre-menopausal 8 6 14
Peri-menopausal 1 2 3
Post-menopausal 14 15 29
Not Reported 2 2 4
Number of participants who received prior chemotherapy in neoadjuvant/adjuvant setting  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
8 8 16
1.Primary Outcome
Title Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)
Hide Description Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.
Time Frame Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.0
(38.7 to 78.9)
52.0
(31.3 to 72.2)
2.Primary Outcome
Title Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Hide Description BOR was the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Refer to Outcome Measure 3 for definition of PD.
Time Frame Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
Complete response 3 2
Partial response 12 11
Stable disease 6 9
Progressive disease 1 1
Unable to determine (UTD; Death due to toxicity) 1 0
UTD (reason other than toxicity or progression) 1 1
Never treated 1 1
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description

Time in months from randomization until first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.

Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method.

Time Frame From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants who did not progress or died were censored on the date of their last tumor assessment.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 25
Median (95% Confidence Interval)
Unit of Measure: months
11.3
(5.8 to 16.8)
13.0
(6.7 to 21.6)
4.Secondary Outcome
Title Time to Response
Hide Description

Time to response was defined as the time in weeks from randomization until the measurement criteria are first met for a CR or PR, whichever is recorded first.

CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method.

Time Frame From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with CR or PR.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 13
Median (Full Range)
Unit of Measure: weeks
10.1
(5.9 to 18.4)
7.3
(5.0 to 18.1)
5.Secondary Outcome
Title Duration of Response
Hide Description

Period measured in months from time that measurement criteria were first met for CR or PR until first date of documented PD or death from any cause without prior documentation of progression.

PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. Refer to Outcome Measure 1 for definitions of CR and PR. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by Brookmeyer and Crowley method.

Time Frame From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with CR or PR. The participants who neither relapsed nor died were censored on the date of their last tumor assessment.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 13
Median (95% Confidence Interval)
Unit of Measure: months
11.5
(6.8 to 21.4)
16.5 [1] 
(7.2 to NA)
[1]
Data insufficient to estimate the upper limit of the confidence interval.
6.Secondary Outcome
Title Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Hide Description AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3=Severe; and Grade 4=Life-threatening or disabling. GR=Grade.
Time Frame Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants: Participants who received at least 1 dose of study therapy.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
All deaths 1 1
Death within 30 days of last dose of study therapy 1 0
SAEs (Any Grade) 6 13
SAEs (Grades 3-4) 4 12
Drug-related SAEs (Any Grade) 3 10
Drug-related SAEs (Grades 3-4) 2 8
AEs (Any Grade) 24 24
AEs (Grades 3-4) 19 23
Drug-related AEs (Any Grade) 24 24
Drug-related AEs (Grades 3-4) 18 22
AEs leading to discontinuation of therapy (Any GR) 5 9
AEs leading to discontinuation of therapy (GR 3-4) 2 4
Drug-related peripheral neuropathy (Any Grade) 16 12
Drug-related peripheral neuropathy (Grades 3-4) 2 0
7.Secondary Outcome
Title Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0
Hide Description Grade (GR)1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.
Time Frame Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
WBC Grade 1 (n=24; n=22) 6 1
WBC Grade 2 (n=24; n=22) 7 1
WBC Grade 3 (n=24; n=22) 8 15
WBC Grade 4 (n=24; n=22) 1 4
ANC Grade 1 (n=23; n=23) 2 0
ANC Grade 2 (n=23; n=23) 4 0
ANC Grade 3 (n=23; n=23) 8 3
ANC Grade 4 (n=23; n=23) 6 19
Platelet Count Grade 1 (n=24; n=23) 9 3
Platelet Count Grade 2 (n=24; n=23) 0 0
Platelet Count Grade 3 (n=24; n=23) 0 0
Platelet Count Grade 4 (n=24; n=23) 1 0
Hemoglobin Grade 1 (n=24; n=23) 14 12
Hemoglobin Grade 2 (n=24; n=23) 8 8
Hemoglobin Grade 3 (n=24; n=23) 0 1
Hemoglobin Grade 4 (n=24; n=23) 0 0
8.Secondary Outcome
Title Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0
Hide Description Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.
Time Frame Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.
Arm/Group Title Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV
Hide Arm/Group Description:
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
ALP Grade 1 (n=23; n=23) 11 8
ALP Grade 2 (n=23; n=23) 0 1
ALP Grade 3 (n=23; n=23) 0 0
ALP Grade 4 (n=23; n=23) 0 0
ALT Grade 1 (n=24; n=23) 10 15
ALT Grade 2 (n=24; n=23) 3 0
ALT Grade 3 (n=24; n=23) 0 1
ALT Grade 4 (n=24; n=23) 0 0
AST Grade 1 (n=24; n=23) 13 11
AST Grade 2 (n=24; n=23) 0 1
AST Grade 3 (n=24; n=23) 1 0
AST Grade 4 (n=24; n=23) 0 0
Total Bilirubin Grade 1 (n=24; n=23) 2 2
Total Bilirubin Grade 2 (n=24; n=23) 0 0
Total Bilirubin Grade 3 (n=24; n=23) 1 0
Total Bilirubin Grade 4 (n=24; n=23) 0 0
Creatinine Grade 1 (n=24; n=23) 2 1
Creatinine Grade 2 (n=24; n=23) 2 0
Creatinine Grade 3 (n=24; n=23) 0 0
Creatinine Grade 4 (n=24; n=23) 0 0
Time Frame Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity. trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
All-Cause Mortality
Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV
Affected / at Risk (%) Affected / at Risk (%)
Total   13/24 (54.17%)   6/24 (25.00%) 
Blood and lymphatic system disorders     
FEBRILE NEUTROPENIA  1  5/24 (20.83%)  0/24 (0.00%) 
HAEMATOTOXICITY  1  0/24 (0.00%)  1/24 (4.17%) 
NEUTROPENIA  1  3/24 (12.50%)  0/24 (0.00%) 
LYMPHADENOPATHY  1  0/24 (0.00%)  1/24 (4.17%) 
Cardiac disorders     
PERICARDIAL EFFUSION  1  1/24 (4.17%)  0/24 (0.00%) 
ATRIAL FIBRILLATION  1  1/24 (4.17%)  0/24 (0.00%) 
Congenital, familial and genetic disorders     
APLASIA  1  0/24 (0.00%)  1/24 (4.17%) 
Gastrointestinal disorders     
NAUSEA  1  0/24 (0.00%)  1/24 (4.17%) 
General disorders     
PYREXIA  1  1/24 (4.17%)  0/24 (0.00%) 
EXTRAVASATION  1  0/24 (0.00%)  1/24 (4.17%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/24 (4.17%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
PATHOLOGICAL FRACTURE  1  1/24 (4.17%)  0/24 (0.00%) 
Nervous system disorders     
ATAXIA  1  0/24 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
PLEURAL EFFUSION  1  1/24 (4.17%)  0/24 (0.00%) 
DYSPNOEA  1  2/24 (8.33%)  0/24 (0.00%) 
Vascular disorders     
CIRCULATORY COLLAPSE  1  0/24 (0.00%)  1/24 (4.17%) 
HYPERTENSION  1  1/24 (4.17%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV
Affected / at Risk (%) Affected / at Risk (%)
Total   23/24 (95.83%)   24/24 (100.00%) 
Blood and lymphatic system disorders     
LEUKOPENIA  1  6/24 (25.00%)  5/24 (20.83%) 
FEBRILE NEUTROPENIA  1  2/24 (8.33%)  1/24 (4.17%) 
ANAEMIA  1  8/24 (33.33%)  4/24 (16.67%) 
NEUTROPENIA  1  14/24 (58.33%)  11/24 (45.83%) 
Cardiac disorders     
PALPITATIONS  1  0/24 (0.00%)  2/24 (8.33%) 
PERICARDIAL EFFUSION  1  2/24 (8.33%)  0/24 (0.00%) 
TACHYCARDIA  1  1/24 (4.17%)  3/24 (12.50%) 
Eye disorders     
LACRIMATION INCREASED  1  2/24 (8.33%)  0/24 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  4/24 (16.67%)  1/24 (4.17%) 
CONSTIPATION  1  3/24 (12.50%)  2/24 (8.33%) 
STOMATITIS  1  4/24 (16.67%)  2/24 (8.33%) 
GASTRITIS  1  0/24 (0.00%)  2/24 (8.33%) 
VOMITING  1  4/24 (16.67%)  5/24 (20.83%) 
DYSPEPSIA  1  2/24 (8.33%)  2/24 (8.33%) 
ABDOMINAL PAIN UPPER  1  3/24 (12.50%)  3/24 (12.50%) 
DIARRHOEA  1  12/24 (50.00%)  7/24 (29.17%) 
NAUSEA  1  4/24 (16.67%)  7/24 (29.17%) 
General disorders     
MUCOSAL INFLAMMATION  1  6/24 (25.00%)  2/24 (8.33%) 
PYREXIA  1  9/24 (37.50%)  4/24 (16.67%) 
ASTHENIA  1  5/24 (20.83%)  8/24 (33.33%) 
FATIGUE  1  5/24 (20.83%)  4/24 (16.67%) 
INFLUENZA LIKE ILLNESS  1  2/24 (8.33%)  0/24 (0.00%) 
PAIN  1  2/24 (8.33%)  5/24 (20.83%) 
OEDEMA PERIPHERAL  1  4/24 (16.67%)  1/24 (4.17%) 
Immune system disorders     
HYPERSENSITIVITY  1  2/24 (8.33%)  5/24 (20.83%) 
DRUG HYPERSENSITIVITY  1  2/24 (8.33%)  0/24 (0.00%) 
Infections and infestations     
PHARYNGITIS  1  1/24 (4.17%)  4/24 (16.67%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  3/24 (12.50%)  6/24 (25.00%) 
NEUTROPHIL COUNT  1  1/24 (4.17%)  2/24 (8.33%) 
WEIGHT INCREASED  1  3/24 (12.50%)  4/24 (16.67%) 
WHITE BLOOD CELL COUNT DECREASED  1  4/24 (16.67%)  2/24 (8.33%) 
HAEMOGLOBIN DECREASED  1  1/24 (4.17%)  2/24 (8.33%) 
NEUTROPHIL COUNT DECREASED  1  4/24 (16.67%)  3/24 (12.50%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/24 (8.33%)  4/24 (16.67%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  5/24 (20.83%)  6/24 (25.00%) 
MUSCULOSKELETAL CHEST PAIN  1  0/24 (0.00%)  2/24 (8.33%) 
BONE PAIN  1  3/24 (12.50%)  2/24 (8.33%) 
MUSCULOSKELETAL PAIN  1  1/24 (4.17%)  4/24 (16.67%) 
PAIN IN EXTREMITY  1  2/24 (8.33%)  8/24 (33.33%) 
BACK PAIN  1  0/24 (0.00%)  3/24 (12.50%) 
MYALGIA  1  1/24 (4.17%)  6/24 (25.00%) 
Nervous system disorders     
PARAESTHESIA  1  4/24 (16.67%)  8/24 (33.33%) 
NEUROTOXICITY  1  1/24 (4.17%)  2/24 (8.33%) 
DIZZINESS  1  0/24 (0.00%)  2/24 (8.33%) 
SENSORY LOSS  1  0/24 (0.00%)  3/24 (12.50%) 
HEADACHE  1  2/24 (8.33%)  4/24 (16.67%) 
NEUROPATHY PERIPHERAL  1  2/24 (8.33%)  2/24 (8.33%) 
PERIPHERAL SENSORY NEUROPATHY  1  7/24 (29.17%)  7/24 (29.17%) 
Psychiatric disorders     
DEPRESSION  1  0/24 (0.00%)  3/24 (12.50%) 
INSOMNIA  1  1/24 (4.17%)  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  5/24 (20.83%)  5/24 (20.83%) 
DYSPNOEA  1  3/24 (12.50%)  3/24 (12.50%) 
EPISTAXIS  1  2/24 (8.33%)  3/24 (12.50%) 
Skin and subcutaneous tissue disorders     
RASH  1  3/24 (12.50%)  0/24 (0.00%) 
NAIL DISORDER  1  4/24 (16.67%)  3/24 (12.50%) 
DERMATITIS  1  2/24 (8.33%)  1/24 (4.17%) 
ALOPECIA  1  7/24 (29.17%)  9/24 (37.50%) 
Vascular disorders     
HYPERTENSION  1  2/24 (8.33%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT00490646    
Other Study ID Numbers: CA163-140
Eudract No: 2007-000721-21
First Submitted: June 21, 2007
First Posted: June 25, 2007
Results First Submitted: June 14, 2012
Results First Posted: July 18, 2012
Last Update Posted: March 10, 2016