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Ixabepilone + Carboplatin Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01075100
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
US Oncology Research

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Ixabepilone
Drug: Carboplatin
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Period Title: Overall Study
Started 49 54
Completed 0 1
Not Completed 49 53
Reason Not Completed
Adverse Event             15             18
Patient Request             4             4
Investigator Request             2             1
Disease Progression             25             29
Other             3             1
Arm/Group Title Triple Negative HR Positive Total
Hide Arm/Group Description ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 49 54 103
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 54 participants 103 participants
55.0  (9.0) 56.7  (10.6) 55.9  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 54 participants 103 participants
Female
49
 100.0%
54
 100.0%
103
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 54 participants 103 participants
Caucasian 33 39 72
Hispanic 2 2 4
Hawaiian 0 1 1
Black 14 10 24
Asian 0 2 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 54 participants 103 participants
49 54 103
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description

Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).

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; Overall Response (OR) = CR + PR.

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description:
ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Overall Number of Participants Analyzed 46 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.4
(17.7 to 45.8)
34
(21.5 to 48.3)
2.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description:
ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Overall Number of Participants Analyzed 46 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.3
(27.0 to 56.8)
56.6
(42.3 to 70.2)
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 using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description:
ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Overall Number of Participants Analyzed 49 54
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(4.3 to 8.4)
7.6
(4.2 to 9.8)
4.Secondary Outcome
Title Overall Survival (OS)
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 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description:
ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Overall Number of Participants Analyzed 49 54
Median (95% Confidence Interval)
Unit of Measure: months
12.5
(10.2 to 14.2)
17.9
(14.4 to 22.4)
5.Secondary Outcome
Title Time to Response
Hide Description For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieve a major objective response (CR or PR).
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description:
ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Overall Number of Participants Analyzed 14 18
Median (Full Range)
Unit of Measure: months
1.27
(0.92 to 3.98)
1.60
(1.12 to 8.95)
6.Secondary Outcome
Title Duration of Response
Hide Description The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieved CR or PR.
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description:
ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
Overall Number of Participants Analyzed 14 18
Median (Full Range)
Unit of Measure: months
6.68
(2.43 to 20.4)
5.92
(1.84 to 25.6)
Time Frame During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description For treated patients only, assessed at each treatment visit.
 
Arm/Group Title Triple Negative HR Positive
Hide Arm/Group Description ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
All-Cause Mortality
Triple Negative HR Positive
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Triple Negative HR Positive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/48 (20.83%)      5/53 (9.43%)    
Blood and lymphatic system disorders     
NEUTROPENIA  1  1/48 (2.08%)  1 1/53 (1.89%)  1
THROMBOCYTOPENIA  1  0/48 (0.00%)  0 1/53 (1.89%)  1
VOLUME BLOOD DECREASED  1  1/48 (2.08%)  1 0/53 (0.00%)  0
Cardiac disorders     
FIBRILLATION ATRIAL  1  1/48 (2.08%)  1 0/53 (0.00%)  0
HYPOTENSION  1  1/48 (2.08%)  2 0/53 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/48 (2.08%)  1 0/53 (0.00%)  0
APPETITE DECREASED  1  0/48 (0.00%)  0 1/53 (1.89%)  1
DEHYDRATION  1  4/48 (8.33%)  4 0/53 (0.00%)  0
DIARRHEA  1  4/48 (8.33%)  4 0/53 (0.00%)  0
NAUSEA  1  3/48 (6.25%)  3 1/53 (1.89%)  1
VOMITING  1  2/48 (4.17%)  2 1/53 (1.89%)  1
General disorders     
FEVER  1  1/48 (2.08%)  1 1/53 (1.89%)  1
RIGORS  1  0/48 (0.00%)  0 1/53 (1.89%)  1
WEAKNESS GENERALIZED  1  1/48 (2.08%)  1 0/53 (0.00%)  0
Infections and infestations     
BACTERIAL RESISTANCE  1  0/48 (0.00%)  0 1/53 (1.89%)  1
SEPSIS  1  1/48 (2.08%)  1 1/53 (1.89%)  1
Metabolism and nutrition disorders     
HYPOKALEMIA  1  1/48 (2.08%)  1 0/53 (0.00%)  0
HYPONATREMIA  1  1/48 (2.08%)  1 0/53 (0.00%)  0
Nervous system disorders     
DIZZINESS  1  1/48 (2.08%)  1 0/53 (0.00%)  0
Renal and urinary disorders     
RENAL INSUFFICIENCY  1  1/48 (2.08%)  1 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
EMBOLISM PULMONARY  1  0/48 (0.00%)  0 1/53 (1.89%)  1
PNEUMONIA  1  0/48 (0.00%)  0 1/53 (1.89%)  1
RESPIRATION RATE DECREASED  1  0/48 (0.00%)  0 1/53 (1.89%)  1
SHORTNESS OF BREATH  1  1/48 (2.08%)  1 0/53 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE 4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Triple Negative HR Positive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/48 (91.67%)      52/53 (98.11%)    
Blood and lymphatic system disorders     
ANEMIA  1  27/48 (56.25%)  58 28/53 (52.83%)  103
EDEMA  1  1/48 (2.08%)  1 3/53 (5.66%)  3
LEUCOPENIA  1  6/48 (12.50%)  13 14/53 (26.42%)  58
NEUTROPENIA  1  31/48 (64.58%)  99 39/53 (73.58%)  184
THROMBOCYTOPENIA  1  16/48 (33.33%)  44 25/53 (47.17%)  65
Gastrointestinal disorders     
ABDOMINAL PAIN  1  6/48 (12.50%)  6 5/53 (9.43%)  6
ANOREXIA  1  6/48 (12.50%)  8 13/53 (24.53%)  18
CONSTIPATION  1  6/48 (12.50%)  6 13/53 (24.53%)  17
DEHYDRATION  1  1/48 (2.08%)  1 7/53 (13.21%)  12
DIARRHEA  1  13/48 (27.08%)  18 15/53 (28.30%)  22
DYSGUESIA  1  6/48 (12.50%)  6 8/53 (15.09%)  12
DYSPEPSIA  1  1/48 (2.08%)  1 3/53 (5.66%)  3
GASTROESOPHAGEAL REFLUX  1  2/48 (4.17%)  2 3/53 (5.66%)  3
NAUSEA  1  23/48 (47.92%)  40 31/53 (58.49%)  47
VOMITING  1  8/48 (16.67%)  12 19/53 (35.85%)  26
General disorders     
CHILLS  1  3/48 (6.25%)  3 0/53 (0.00%)  0
FATIGUE  1  18/48 (37.50%)  29 31/53 (58.49%)  58
FEVER  1  3/48 (6.25%)  3 3/53 (5.66%)  3
PAIN  1  2/48 (4.17%)  2 5/53 (9.43%)  6
WEAKNESS  1  4/48 (8.33%)  6 2/53 (3.77%)  2
WEIGHT LOSS  1  3/48 (6.25%)  3 3/53 (5.66%)  3
Immune system disorders     
ALLERGIC REACTION  1  3/48 (6.25%)  3 5/53 (9.43%)  6
Infections and infestations     
MUCOSITIS  1  1/48 (2.08%)  1 3/53 (5.66%)  4
Metabolism and nutrition disorders     
HYPOKALEMIA  1  3/48 (6.25%)  4 3/53 (5.66%)  4
HYPOMAGNESAEMIA  1  3/48 (6.25%)  3 1/53 (1.89%)  2
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/48 (0.00%)  0 4/53 (7.55%)  6
MUSCLE WEAKNESS  1  3/48 (6.25%)  8 1/53 (1.89%)  1
MYALGIA  1  2/48 (4.17%)  3 5/53 (9.43%)  5
PAIN BACK  1  0/48 (0.00%)  0 3/53 (5.66%)  3
Nervous system disorders     
DIZZINESS  1  2/48 (4.17%)  2 4/53 (7.55%)  4
NEUROPATHY  1  22/48 (45.83%)  35 27/53 (50.94%)  51
Skin and subcutaneous tissue disorders     
ALOPECIA  1  15/48 (31.25%)  16 20/53 (37.74%)  22
NAIL DISORDER  1  3/48 (6.25%)  4 6/53 (11.32%)  7
RASH  1  0/48 (0.00%)  0 5/53 (9.43%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE 4.0
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. Cynthia Osborne
Organization: US Oncology Research, McKesson Specialty Health
Phone: 214-370-1057
EMail: Cynthia.Osborne@usoncology.com
Layout table for additonal information
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT01075100    
Other Study ID Numbers: 08007
First Submitted: January 14, 2010
First Posted: February 24, 2010
Results First Submitted: January 12, 2016
Results First Posted: December 7, 2016
Last Update Posted: December 7, 2016