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Trial record 88 of 195 for:    Oral Cancer | ( Map: Mexico )

Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00667251
Recruitment Status : Active, not recruiting
First Posted : April 28, 2008
Results First Posted : June 18, 2014
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: trastuzumab
Drug: docetaxel
Drug: lapatinib ditosylate
Drug: paclitaxel
Enrollment 649
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description Lapatinib - 1250 mg po daily Taxane based chemotherapy: Paclitaxel - 80 mg/m2 IV q weekly (days 1, 8 and 15 of a 4-week cycle) or Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3-week cycle) plus G-CSF - according to institutional standards. Followed by: Lapatinib - 1500 mg po daily until disease progression. Trastuzumab ng- IV weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) Paclitaxel - 80 mg/m2 IV weekly (days 1, 8 and 15 of a 4-week cycle). or Trastuzumab - IV weekly (loading dose 8 mg/kg, subsequent doses 6 mg/kg) Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3 week cycle) Followed by: Trastuzumab - 6 mg/kg IV q 3 weekly until disease progression.
Period Title: Overall Study
Started 326 326
Combination Rx 322 325
Monotherapy 225 232
Not Started 4 1
Completed 256 231
Not Completed 70 95
Reason Not Completed
Adverse Event             13             4
Withdrawal by Subject             6             2
Other/missing             46             84
Intercurrent Illness             4             3
Symptomatic progression             1             2
Arm/Group Title Lapatinib Trastuzumab Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 326 326 652
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
260
  79.8%
263
  80.7%
523
  80.2%
>=65 years
66
  20.2%
63
  19.3%
129
  19.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 326 participants 326 participants 652 participants
55.4
(26.6 to 87.1)
54.4
(29.3 to 84.3)
54.9
(26.6 to 87.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Female
326
 100.0%
326
 100.0%
652
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Hispanic or Latino
34
  10.4%
34
  10.4%
68
  10.4%
Not Hispanic or Latino
288
  88.3%
283
  86.8%
571
  87.6%
Unknown or Not Reported
4
   1.2%
9
   2.8%
13
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
American Indian or Alaska Native
4
   1.2%
4
   1.2%
8
   1.2%
Asian
67
  20.6%
74
  22.7%
141
  21.6%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
Black or African American
5
   1.5%
8
   2.5%
13
   2.0%
White
246
  75.5%
234
  71.8%
480
  73.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   0.9%
6
   1.8%
9
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Country
Number Analyzed 326 participants 326 participants 652 participants
United States 10 13 23
Taiwan 11 11 22
Thailand 9 12 21
Spain 19 19 38
Ukraine 4 4 8
Russian Federation 55 46 101
Israel 16 15 31
United Kingdom 33 32 65
Italy 5 8 13
India 4 4 8
France 5 5 10
Mexico 3 6 9
Canada 39 36 75
Argentina 8 4 12
Poland 7 12 19
Belgium 3 6 9
Australia 17 13 30
Netherlands 7 7 14
Germany 32 34 66
Japan 22 20 42
Korea, Republic of 17 19 36
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
ECOG 0 196 204 400
ECOG 1 118 112 230
ECOG 2 12 10 22
[1]
Measure Description: Grade 0= Fully active, able to carry on all pre-disease performance without restriction. Grade 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2= Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Grade 3= Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. Grade 4= Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. Grade 5= Dead
Prior (Neo) Adjuvant Anti-HER2/neu Targeted Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 59 59 118
No 267 267 534
Prior (Neo) Adjuvant Taxane Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 65 69 134
No 261 257 518
Prior (Neo) Adjuvant Anthracyclines  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 128 140 268
No 198 186 384
Prior (Neo) Adjuvant Other Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 146 161 307
No 180 165 345
Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Primary Diagnosis 138 138 276
Metastatic Relapse 187 187 374
Missing 1 1 2
Prior (Neo) Adjuvant/Metastatic Endocrine Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 122 127 249
No 204 198 402
Missing 0 1 1
Prior (Neo) Adjuvant/Metastatic Radiotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 138 149 287
No 187 176 363
Missing 1 1 2
Planned Taxane Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Weekly Paclitaxel 146 146 292
3-Weekly Docetaxel 180 180 360
Prior (Neo) Adjuvant Other Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 5 2 7
No 321 323 644
Missing 0 1 1
Liver Metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Yes 149 150 299
No 177 176 353
Central Review HER2/Neu Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Positive IHC or FISH 270 267 537
Negative IHC and FISH 36 46 82
Equivocal IHC and FISH 9 5 14
Unknown 11 8 19
Central Review ER Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Positive (>0) 213 208 421
Negative 96 107 203
Missing 17 11 28
Central Review PR Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Positive (>0) 116 104 220
Negative 190 204 394
Missing 20 18 38
Central Review ki67  
Geometric Mean (Full Range)
Unit of measure:  % cells positive
Number Analyzed 326 participants 326 participants 652 participants
33.33
(0 to 100)
31.43
(0 to 90)
32.37
(0 to 100)
Central Review CK5 Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Positive (>0) 58 41 99
Negative 210 218 428
Missing 58 67 125
Central Review EGFR Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 326 participants 326 participants 652 participants
Positive (>0) 71 77 148
Negative 194 181 375
Missing 61 68 129
1.Primary Outcome
Title Progression-free Survival
Hide Description 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 From randomization to RECIST V 1.0 progression or death assessed up to 39 months.
Hide Outcome Measure Data
Hide Analysis Population Description
two subpopulations: ITT (n=652) and HER2+ (n=537)
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 326 326
Median (Full Range)
Unit of Measure: Months
ITT n=326, 326
8.97
(0.0 to 32.69)
11.30
(0.0 to 38.54)
HER2+n=270, 267
9.13
(0.0 to 32.69)
13.63
(0.0 to 38.54)
2.Secondary Outcome
Title Overall Survival
Hide Description OS median follow-up not achieved; estimated with quartile estimates
Time Frame From randomization to death from any cause, assessed up to 44 months.
Hide Outcome Measure Data
Hide Analysis Population Description
two subpopulations: ITT (n=652) and HER2+ (n=537)
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 326 326
Median (Inter-Quartile Range)
Unit of Measure: Months
20.8
(14.2 to 31.3)
21.8
(14.3 to 30.6)
3.Secondary Outcome
Title Time to CNS Metastases at the Time of First Progression
Hide Description [Not Specified]
Time Frame From randomization to CNS metastases at time of first progression, assessed up to 39 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 326 326
Median (Full Range)
Unit of Measure: Months
ITT n=326, 326
8.77
(0.0 to 32.69)
11.10
(0.0 to 38.54)
HER2+n=270, 267
9.03
(0.0 to 32.69)
13.17
(0.0 to 38.54)
4.Secondary Outcome
Title CNS Metastases at the Time of Progression (ITT)
Hide Description [Not Specified]
Time Frame Incidence rate of CNS metastases at first progression assessed up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
178 Lapatinib patients with metastases assessed for CNS metastases; 157 Trastuzumab patients with metastases assessed for CNS metastases.
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 178 157
Measure Type: Number
Unit of Measure: CNS metastases
44 52
5.Secondary Outcome
Title CNS Metastases at the Time of Progression (HER2+)
Hide Description [Not Specified]
Time Frame Incidence rate of CNS mestastes at first progression, assessed up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
151 patients with metastases assessed for CNS metastases; 128 patients with metastases assessed for CNS metastases.
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 151 128
Measure Type: Number
Unit of Measure: CNS metastases
40 48
6.Secondary Outcome
Title Overall Objective Response Rate (Complete or Partial) ITT
Hide Description Patients included in this assessment must have had at least one measurable lesion at baseline, and had at least one RECIST re-evaluation after baseline while on protocol therapy, prior to, or on, date of progression. Best overall response was classified to be Complete Response (CR) or Partial Response (PR).
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 257 270
Measure Type: Number
Unit of Measure: Participants
139 148
7.Secondary Outcome
Title Overall Objective Response Rate (Complete or Partial) HER2/Neu+
Hide Description Response determined by RECIST V 1.0
Time Frame Median follow-up of 21.5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 216 224
Measure Type: Number
Unit of Measure: Participants
121 130
8.Secondary Outcome
Title Clinical Benefit Response Rate (ITT)
Hide Description Best overall response of CR, PR or stable disease at end of week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 289 303
Measure Type: Number
Unit of Measure: Participants
219 230
9.Secondary Outcome
Title Clinical Benefit Response Rate (HER2/Neu+))
Hide Description Best overall response of CR, PR, or stable disease at end of week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 238 251
Measure Type: Number
Unit of Measure: Participants
180 195
10.Secondary Outcome
Title Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks
Hide Description The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life. At 12 weeks: Group mean difference between arms
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description:
Plus taxane based chemotherapy
Plus taxane based chemotherapy.
Overall Number of Participants Analyzed 260 266
Mean (Standard Deviation)
Unit of Measure: Score on global scale
61.67  (20.93) 64.41  (20.18)
11.Secondary Outcome
Title Effects of Changes in Biomarkers on Clinical Outcomes
Hide Description [Not Specified]
Time Frame Not available at this time
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization
Hide Description [Not Specified]
Time Frame Not available at this time
Outcome Measure Data Not Reported
Time Frame Median follow-up of 21.5 months
Adverse Event Reporting Description Serious Adverse Events that were reported to Health Canada
 
Arm/Group Title Lapatinib Trastuzumab
Hide Arm/Group Description Plus taxane based chemotherapy Plus taxane based chemotherapy.
All-Cause Mortality
Lapatinib Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib Trastuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/322 (0.93%)      0/325 (0.00%)    
Blood and lymphatic system disorders     
Hemorrhage  1  1/322 (0.31%)  1 0/325 (0.00%)  0
General disorders     
Sudden Death  1  1/322 (0.31%)  1 0/325 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Colitis  1  1/322 (0.31%)  1 0/325 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lapatinib Trastuzumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   315/322 (97.83%)      322/325 (99.08%)    
Blood and lymphatic system disorders     
Hemorrhage pulmonary - Nose  1 [1]  59/322 (18.32%)  41/325 (12.62%) 
Edema: head and neck  1 [1]  17/322 (5.28%)  10/325 (3.08%) 
Edema: Limb  1 [1]  81/322 (25.16%)  107/325 (32.92%) 
Hemorrhage pulmonary - Nose  1 [2]  19/322 (5.90%)  6/325 (1.85%) 
Edema: Limb  1 [2]  54/322 (16.77%)  71/325 (21.85%) 
Cardiac disorders     
Hypertension  1 [1]  18/322 (5.59%)  26/325 (8.00%) 
Hypertension  1 [2]  14/322 (4.35%)  24/325 (7.38%) 
Left Ventricular Systolic Dysfunction  1 [2]  8/322 (2.48%)  16/325 (4.92%) 
Endocrine disorders     
Hot Flashes  1 [1]  24/322 (7.45%)  27/325 (8.31%) 
Hot Flashes  1 [2]  18/322 (5.59%)  23/325 (7.08%) 
Eye disorders     
Blurred Vision  1 [1]  15/322 (4.66%)  13/325 (4.00%) 
Watery Eye  1 [1]  26/322 (8.07%)  34/325 (10.46%) 
Watery Eye  1 [2]  17/322 (5.28%)  27/325 (8.31%) 
Gastrointestinal disorders     
Anorexia  1 [1]  100/322 (31.06%)  67/325 (20.62%) 
Constipation  1 [1]  69/322 (21.43%)  85/325 (26.15%) 
Diarrhea  1 [1]  254/322 (78.88%)  126/325 (38.77%) 
Distention  1 [1]  18/322 (5.59%)  7/325 (2.15%) 
Dry Mouth  1 [1]  19/322 (5.90%)  12/325 (3.69%) 
Heartburn  1 [1]  62/322 (19.25%)  56/325 (17.23%) 
Hemmorroids  1 [1]  15/322 (4.66%)  3/325 (0.92%) 
Mucositis (clinical exam)  1 [1]  130/322 (40.37%)  100/325 (30.77%) 
Nausea  1 [1]  153/322 (47.52%)  135/325 (41.54%) 
Taste Alteration  1 [1]  54/322 (16.77%)  50/325 (15.38%) 
Vomiting  1 [1]  96/322 (29.81%)  65/325 (20.00%) 
Pain Abdomen NOS  1 [1]  45/322 (13.98%)  30/325 (9.23%) 
Pain - stomach  1 [1]  16/322 (4.97%)  12/325 (3.69%) 
Pain - throat/pharynx/larynx  1 [1]  12/322 (3.73%)  26/325 (8.00%) 
Anorexia  1 [2]  44/322 (13.66%)  23/325 (7.08%) 
Constipation  1 [2]  17/322 (5.28%)  19/325 (5.85%) 
Diarrhea  1 [2]  96/322 (29.81%)  26/325 (8.00%) 
Heartburn  1 [2]  23/322 (7.14%)  21/325 (6.46%) 
Mucositis (clinical exam)-oral cavity  1 [2]  19/322 (5.90%)  17/325 (5.23%) 
Nausea  1 [2]  39/322 (12.11%)  27/325 (8.31%) 
Taste Alteration  1 [2]  20/322 (6.21%)  20/325 (6.15%) 
Vomiting  1 [2]  16/322 (4.97%)  17/325 (5.23%) 
Pain Abdomen NOS  1 [2]  16/322 (4.97%)  13/325 (4.00%) 
General disorders     
Fatigue  1 [1]  221/322 (68.63%)  206/325 (63.38%) 
Fever  1 [1]  49/322 (15.22%)  57/325 (17.54%) 
Insomnia  1 [1]  61/322 (18.94%)  67/325 (20.62%) 
Rigors/Chills  1 [1]  9/322 (2.80%)  19/325 (5.85%) 
Weight Gain  1 [1]  5/322 (1.55%)  17/325 (5.23%) 
Weight Loss  1 [1]  26/322 (8.07%)  11/325 (3.38%) 
Flu-like Syndrome  1 [1]  17/322 (5.28%)  19/325 (5.85%) 
Fatigue  1 [2]  123/322 (38.20%)  128/325 (39.38%) 
Insomnia  1 [2]  36/322 (11.18%)  42/325 (12.92%) 
Flu-like Syndrome  1 [2]  9/322 (2.80%)  17/325 (5.23%) 
Fatigue  1 [3]  46/322 (14.29%)  35/325 (10.77%) 
Immune system disorders     
Allergic reaction  1 [1]  31/322 (9.63%)  43/325 (13.23%) 
Rhinitis  1 [1]  24/322 (7.45%)  25/325 (7.69%) 
Rhinitis  1 [2]  13/322 (4.04%)  20/325 (6.15%) 
Infections and infestations     
Febrile Neutropenia  1 [1]  17/322 (5.28%)  10/325 (3.08%) 
Infections with normal ANC Ungual  1 [1]  17/322 (5.28%)  3/325 (0.92%) 
Infections with normal ANC Upper Airway NOS  1 [1]  27/322 (8.39%)  21/325 (6.46%) 
Infections with normal ANC Ungual  1 [2]  15/322 (4.66%)  6/325 (1.85%) 
Infections with normal ANC Upper Airway NOS  1 [2]  1/322 (0.31%)  16/325 (4.92%) 
Musculoskeletal and connective tissue disorders     
Pain - back  1 [1]  49/322 (15.22%)  63/325 (19.38%) 
Pain - bone  1 [1]  61/322 (18.94%)  66/325 (20.31%) 
Pain - chest/thorax NOS  1 [1]  7/322 (2.17%)  18/325 (5.54%) 
Pain - extremity limb  1 [1]  30/322 (9.32%)  41/325 (12.62%) 
Pain - joint  1 [1]  69/322 (21.43%)  76/325 (23.38%) 
Pain - muscle  1 [1]  76/322 (23.60%)  73/325 (22.46%) 
Pain - back  1 [2]  20/322 (6.21%)  35/325 (10.77%) 
Pain - bone  1 [2]  25/322 (7.76%)  37/325 (11.38%) 
Pain - extremity limb  1 [2]  19/322 (5.90%)  29/325 (8.92%) 
Pain - joint  1 [2]  32/322 (9.94%)  54/325 (16.62%) 
Pain - muscle  1 [2]  24/322 (7.45%)  27/325 (8.31%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pain - tumour pain  1 [1]  16/322 (4.97%)  20/325 (6.15%) 
Nervous system disorders     
Dizziness  1 [1]  27/322 (8.39%)  37/325 (11.38%) 
Neuropathy-motor  1 [1]  15/322 (4.66%)  16/325 (4.92%) 
Neuropathy-sensory  1 [1]  164/322 (50.93%)  159/325 (48.92%) 
Pain - headache  1 [1]  52/322 (16.15%)  53/325 (16.31%) 
Dizziness  1 [2]  16/322 (4.97%)  28/325 (8.62%) 
Neuropathy-motor  1 [2]  10/322 (3.11%)  15/325 (4.62%) 
Neuropathy-sensory  1 [2]  116/322 (36.02%)  126/325 (38.77%) 
Pain - headache  1 [2]  27/322 (8.39%)  34/325 (10.46%) 
Neuropathy-sensory  1 [3]  53/322 (16.46%)  49/325 (15.08%) 
Psychiatric disorders     
Mood Alteration - Anxiety  1 [1]  30/322 (9.32%)  29/325 (8.92%) 
Mood Alteration - Depression  1 [1]  24/322 (7.45%)  25/325 (7.69%) 
Mood Alteration - Anxiety  1 [2]  19/322 (5.90%)  20/325 (6.15%) 
Mood Alteration - Depression  1 [2]  10/322 (3.11%)  20/325 (6.15%) 
Reproductive system and breast disorders     
Pain - breast  1 [1]  21/322 (6.52%)  24/325 (7.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1 [1]  55/322 (17.08%)  74/325 (22.77%) 
Dyspnea  1 [1]  68/322 (21.12%)  80/325 (24.62%) 
Nasal - paranasal reactions  1 [1]  24/322 (7.45%)  18/325 (5.54%) 
Cough  1 [2]  28/322 (8.70%)  40/325 (12.31%) 
Dyspnea  1 [2]  35/322 (10.87%)  41/325 (12.62%) 
Nasal - paranasal reactions  1 [2]  23/322 (7.14%)  7/325 (2.15%) 
Skin and subcutaneous tissue disorders     
Alopecia  1 [1]  217/322 (67.39%)  239/325 (73.54%) 
Dry Skin  1 [1]  54/322 (16.77%)  36/325 (11.08%) 
Flushing  1 [1]  17/322 (5.28%)  13/325 (4.00%) 
Hand Foot Syndrome  1 [1]  24/322 (7.45%)  9/325 (2.77%) 
Nail Changes  1 [1]  118/322 (36.65%)  73/325 (22.46%) 
Puritis  1 [1]  44/322 (13.66%)  28/325 (8.62%) 
Rash  1 [1]  186/322 (57.76%)  113/325 (34.77%) 
Dermatology - Other  1 [1]  21/322 (6.52%)  13/325 (4.00%) 
Alopecia  1 [2]  146/322 (45.34%)  162/325 (49.85%) 
Dry Skin  1 [2]  33/322 (10.25%)  24/325 (7.38%) 
Hand Foot Syndrome  1 [2]  18/322 (5.59%)  5/325 (1.54%) 
Nail Changes  1 [2]  98/322 (30.43%)  69/325 (21.23%) 
Puritis  1 [2]  14/322 (4.35%)  21/325 (6.46%) 
Rash  1 [2]  84/322 (26.09%)  39/325 (12.00%) 
Alopecia  1 [3]  47/322 (14.60%)  55/325 (16.92%) 
Nail Changes  1 [3]  35/322 (10.87%)  14/325 (4.31%) 
Rash  1 [3]  20/322 (6.21%)  4/325 (1.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Acute Period - Combination Therapy >= 5% on at least one arm
[2]
Acute Period - Monotherapy >=5% on at least 1 arm
[3]
Delayed Therapy >=5% on at least 1 arm
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00667251     History of Changes
Other Study ID Numbers: 108919
EGF108919 ( Other Identifier: GSK )
CAN-NCIC-MA31 ( Other Grant/Funding Number: NCI US - Physician Data Query )
2007-004568-27 ( EudraCT Number )
CDR0000594764 ( Other Identifier: PDQ )
First Submitted: April 25, 2008
First Posted: April 28, 2008
Results First Submitted: September 24, 2013
Results First Posted: June 18, 2014
Last Update Posted: September 10, 2019