Trial Outcomes & Findings for Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer (NCT NCT00079326)
NCT ID: NCT00079326
Last Updated: 2014-06-02
Results Overview
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2014-06-02
Participant Flow
Patients were recruited from February 2004 to May 2008 from Dana-Farber Cancer Institute/Partners Cancer Center and Memorial Sloane-Kettering Cancer Center
Participant milestones
| Measure |
Cohort 1: No Prior Chemo or Trastuzumab Treatment
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
24
|
|
Overall Study
COMPLETED
|
15
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: No Prior Chemo or Trastuzumab Treatment
n=15 Participants
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens
n=24 Participants
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
50.07 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
52.67 years
STANDARD_DEVIATION 11.28 • n=7 Participants
|
51.67 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsPer Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
Outcome measures
| Measure |
Cohort 1: No Prior Chemo or Trastuzumab Treatment
n=15 Participants
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens
n=24 Participants
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response Rate
|
73 percentage of participants
Interval 45.0 to 92.0
|
25 percentage of participants
Interval 10.0 to 47.0
|
SECONDARY outcome
Timeframe: up to 6 yearsTime to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.
Outcome measures
| Measure |
Cohort 1: No Prior Chemo or Trastuzumab Treatment
n=15 Participants
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens
n=24 Participants
Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
6.6 months
Interval 4.2 to 11.0
|
6.2 months
Interval 3.4 to 7.1
|
Adverse Events
All Study Participants
Serious events: 7 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Study Participants
n=39 participants at risk
All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/39 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1
|
|
Blood and lymphatic system disorders
Elevated White Blood Cell Count
|
2.6%
1/39 • Number of events 1
|
Other adverse events
| Measure |
All Study Participants
n=39 participants at risk
All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
|
|---|---|
|
Hepatobiliary disorders
ALT,SGPT
|
7.7%
3/39 • Number of events 4
|
|
Hepatobiliary disorders
AST, SGOT
|
10.3%
4/39 • Number of events 6
|
|
Gastrointestinal disorders
Abdomen, pain
|
5.1%
2/39 • Number of events 2
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
12.8%
5/39 • Number of events 8
|
|
Immune system disorders
Allergic Reaction
|
7.7%
3/39 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.9%
14/39 • Number of events 27
|
|
Gastrointestinal disorders
Anorexia
|
15.4%
6/39 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
back,pain
|
7.7%
3/39 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
bone,pain
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
2/39 • Number of events 4
|
|
General disorders
Dehydration
|
7.7%
3/39 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.3%
4/39 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb,pain
|
10.3%
4/39 • Number of events 8
|
|
General disorders
Fatigue
|
38.5%
15/39 • Number of events 20
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like syndrome
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
headache
|
5.1%
2/39 • Number of events 4
|
|
Blood and lymphatic system disorders
hemoglobin
|
17.9%
7/39 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
7.7%
3/39 • Number of events 4
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
7.7%
3/39 • Number of events 3
|
|
Infections and infestations
Infection w/unk ANC bronchus
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
joint, pain
|
25.6%
10/39 • Number of events 11
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.1%
2/39 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes
|
25.6%
10/39 • Number of events 12
|
|
Infections and infestations
Muco/stomatitis (symptom) oral cavity
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle,pain
|
20.5%
8/39 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
12.8%
5/39 • Number of events 6
|
|
Nervous system disorders
Neuropathy-sensory
|
56.4%
22/39 • Number of events 39
|
|
Blood and lymphatic system disorders
Neutrophils
|
23.1%
9/39 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
10.3%
4/39 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.1%
2/39 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
4/39 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60