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A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

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ClinicalTrials.gov Identifier: NCT00679341
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : May 20, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Trastuzumab emtansine [Kadcyla]
Drug: Trastuzumab
Drug: Docetaxel
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle. Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Period Title: Overall Study
Started 67 70
Completed 14 19
Not Completed 53 51
Reason Not Completed
Disease progression             42             36
Adverse Event             5             6
Subject/guardian decision to discontinue             3             0
Death             1             1
Other             1             0
Physician Decision             1             0
Not treated             0             2
Physician/patient decision to withdraw             0             6
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel Total
Hide Arm/Group Description Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle. Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles. Total of all reporting groups
Overall Number of Baseline Participants 67 70 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 70 participants 137 participants
54.3  (12.6) 52.1  (10.7) 53.2  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 70 participants 137 participants
Female
67
 100.0%
70
 100.0%
137
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)
Hide Description PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.
Time Frame Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Overall Number of Participants Analyzed 67 70
Median (95% Confidence Interval)
Unit of Measure: Months
14.2 [1] 
(10.6 to NA)
9.2
(8.2 to 11.2)
[1]
The upper limit of the 95% confidence interval was not reached because of insufficient events.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day.
Time Frame Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Overall Number of Participants Analyzed 67 70
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [2] 
(25.6 to NA)
[1]
The median and the upper and lower confidence intervals were not reached because of insufficient events.
[2]
The median and the upper confidence intervals were not reached because of insufficient events.
3.Secondary Outcome
Title Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Time Frame Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with measureable disease at Baseline.
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of patients
64.2
(51.8 to 74.8)
58.0
(45.5 to 69.2)
4.Secondary Outcome
Title Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Time Frame Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with measureable disease at Baseline. Only patients with an objective response were included in the analysis.
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(15.0 to NA)
9.5
(6.6 to 10.6)
[1]
The median and the upper confidence intervals were not reached because of insufficient events.
5.Secondary Outcome
Title Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description CB was defined as an objective response (complete response [CR], partial response [PR]) or stable disease (SD) for 6 months after randomization. For target lesions (TL), CR=the disappearance of all TL; PR=at least a 30% decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of TL, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions. For non-TL, CR=the disappearance of all non-TL; PR=the persistence of 1 or more non-TL; SD=the persistence of 1 or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits; PD=the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TL.
Time Frame Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with measurable disease at Baseline.
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of patients
74.6
(63.2 to 84.2)
81.2
(70.7 to 89.1)
6.Secondary Outcome
Title Time to Symptom Progression
Hide Description Time to symptom progression was defined as the time from randomization to the first documentation of a ≥ 5-point decrease from baseline in the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) subscale score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B questionnaire is a valid and reliable measure of symptoms associated with breast cancer. The TOI-PFB is a 24-item subscale generated using 3 subsections (Physical Well-Being [7 items], Functional Well-Being [7 items], and Additional Concerns [10 items]) from the FACT-B questionnaire. Patients responded to each item on a scale of 0-4 (Not at all-Very much). The total score ranged from 0 to 96. A higher score indicates fewer symptoms. A positive change score indicates improvement.
Time Frame Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with a Baseline and at least 1 post-Baseline valid score.
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Overall Number of Participants Analyzed 65 67
Median (95% Confidence Interval)
Unit of Measure: Months
7.5
(4.2 to 15.1)
3.5
(2.1 to 6.5)
7.Secondary Outcome
Title Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab
Hide Description Serum samples were collected from all 67 patients enrolled in the trastuzumab emtansine arm using sparse pharmacokinetic sampling. Blood samples were collected prior to dosing and 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. Serum samples were assayed for trastuzumab emtansine and total trastuzumab (sum of unconjugated trastuzumab and emtansine conjugated to trastuzumab) in indirect sandwich ELISAs. The area under the concentration-time curve (AUC) was estimated based on non-compartmental analysis using WinNonlin (Version 5.2.1) software.
Time Frame Baseline through Cycle 5 (up to 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.
Arm/Group Title Trastuzumab Emtansine 3.6 mg/kg
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: day•μg/mL
Trastuzumab emtansine Cycle 1 (n=62) 495  (158)
Trastuzumab emtansine Cycle 5 (n=39) 473  (141)
Total trastuzumab Cycle 1 (n=60) 700  (260)
Total trastuzumab Cycle 5 (n=38) 788  (323)
8.Secondary Outcome
Title Plasma Concentration of Free Emtansine
Hide Description Plasma samples were collected from all 67 patients in the trastuzumab emtansine group 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. The plasma samples were assayed for free emtansine in a mass-spectrometric assay.
Time Frame Baseline through Cycle 5 (up to 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.
Arm/Group Title Trastuzumab Emtansine 3.6 mg/kg
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 (n=62) 5.11  (2.34)
Cycle 5 (n=39) 4.71  (2.25)
Time Frame Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Adverse Event Reporting Description Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
 
Arm/Group Title Trastuzumab Emtansine Trastuzumab + Docetaxel
Hide Arm/Group Description Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle. Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
All-Cause Mortality
Trastuzumab Emtansine Trastuzumab + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Trastuzumab Emtansine Trastuzumab + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   14/69 (20.29%)   17/66 (25.76%) 
Blood and lymphatic system disorders     
Febrile neutropenia †  0/69 (0.00%)  6/66 (9.09%) 
Anaemia †  0/69 (0.00%)  1/66 (1.52%) 
Cardiac disorders     
Atrial fibrillation †  1/69 (1.45%)  1/66 (1.52%) 
Cardiopulmonary failure †  0/69 (0.00%)  1/66 (1.52%) 
Supraventricular extrasystoles †  1/69 (1.45%)  0/66 (0.00%) 
Gastrointestinal disorders     
Abdominal pain †  1/69 (1.45%)  0/66 (0.00%) 
Intestinal obstruction †  0/69 (0.00%)  1/66 (1.52%) 
Vomiting †  1/69 (1.45%)  0/66 (0.00%) 
General disorders     
Chills †  1/69 (1.45%)  0/66 (0.00%) 
Oedema peripheral †  0/69 (0.00%)  1/66 (1.52%) 
Pyrexia †  1/69 (1.45%)  0/66 (0.00%) 
Sudden death †  1/69 (1.45%)  0/66 (0.00%) 
Immune system disorders     
Hypersensitivity †  0/69 (0.00%)  1/66 (1.52%) 
Infections and infestations     
Pneumonia †  5/69 (7.25%)  0/66 (0.00%) 
Cellulitis †  0/69 (0.00%)  2/66 (3.03%) 
Arthritis infective †  0/69 (0.00%)  1/66 (1.52%) 
Sepsis †  1/69 (1.45%)  0/66 (0.00%) 
Injury, poisoning and procedural complications     
Spinal compression fracture †  0/69 (0.00%)  1/66 (1.52%) 
Investigations     
C-reactive protein increased †  0/69 (0.00%)  1/66 (1.52%) 
Metabolism and nutrition disorders     
Dehydration †  1/69 (1.45%)  0/66 (0.00%) 
Hypercalcaemia †  1/69 (1.45%)  0/66 (0.00%) 
Hyperglycaemia †  0/69 (0.00%)  1/66 (1.52%) 
Metabolic acidosis †  0/69 (0.00%)  1/66 (1.52%) 
Tumour lysis syndrome †  1/69 (1.45%)  0/66 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer †  0/69 (0.00%)  1/66 (1.52%) 
Renal and urinary disorders     
Renal failure acute †  0/69 (0.00%)  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion †  1/69 (1.45%)  1/66 (1.52%) 
Alveolitis allergic †  0/69 (0.00%)  1/66 (1.52%) 
Dyspnoea †  0/69 (0.00%)  1/66 (1.52%) 
Epistaxis †  0/69 (0.00%)  1/66 (1.52%) 
Pleuritic pain †  1/69 (1.45%)  0/66 (0.00%) 
Pneumonitis †  1/69 (1.45%)  0/66 (0.00%) 
Pulmonary embolism †  0/69 (0.00%)  1/66 (1.52%) 
Vascular disorders     
Deep vein thrombosis †  0/69 (0.00%)  1/66 (1.52%) 
Hypertensive crisis †  1/69 (1.45%)  0/66 (0.00%) 
Hypovolaemic shock †  1/69 (1.45%)  0/66 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Emtansine Trastuzumab + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   66/69 (95.65%)   66/66 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia †  11/69 (15.94%)  43/66 (65.15%) 
Anaemia †  9/69 (13.04%)  18/66 (27.27%) 
Leukopenia †  7/69 (10.14%)  17/66 (25.76%) 
Thrombocytopenia †  19/69 (27.54%)  4/66 (6.06%) 
Cardiac disorders     
Palpitations †  4/69 (5.80%)  2/66 (3.03%) 
Eye disorders     
Lacrimation increased †  5/69 (7.25%)  13/66 (19.70%) 
Conjunctivitis †  5/69 (7.25%)  3/66 (4.55%) 
Dry eye †  6/69 (8.70%)  0/66 (0.00%) 
Gastrointestinal disorders     
Nausea †  34/69 (49.28%)  29/66 (43.94%) 
Diarrhoea †  11/69 (15.94%)  30/66 (45.45%) 
Vomiting †  17/69 (24.64%)  17/66 (25.76%) 
Constipation †  16/69 (23.19%)  15/66 (22.73%) 
Stomatitis †  8/69 (11.59%)  13/66 (19.70%) 
Dyspepsia †  11/69 (15.94%)  8/66 (12.12%) 
Abdominal pain upper †  12/69 (17.39%)  4/66 (6.06%) 
Dry mouth †  11/69 (15.94%)  3/66 (4.55%) 
Abdominal pain †  6/69 (8.70%)  4/66 (6.06%) 
Toothache †  2/69 (2.90%)  7/66 (10.61%) 
Gingival bleeding †  4/69 (5.80%)  0/66 (0.00%) 
Oral pain †  0/69 (0.00%)  4/66 (6.06%) 
General disorders     
Fatigue †  34/69 (49.28%)  30/66 (45.45%) 
Pyrexia †  28/69 (40.58%)  15/66 (22.73%) 
Oedema peripheral †  7/69 (10.14%)  28/66 (42.42%) 
Asthenia †  16/69 (23.19%)  14/66 (21.21%) 
Mucosal inflammation †  4/69 (5.80%)  12/66 (18.18%) 
Chills †  10/69 (14.49%)  5/66 (7.58%) 
Chest pain †  6/69 (8.70%)  4/66 (6.06%) 
Pain †  2/69 (2.90%)  5/66 (7.58%) 
Influenza like illness †  5/69 (7.25%)  1/66 (1.52%) 
Infections and infestations     
Nasopharyngitis †  11/69 (15.94%)  10/66 (15.15%) 
Upper respiratory tract infection †  10/69 (14.49%)  8/66 (12.12%) 
Urinary tract infection †  5/69 (7.25%)  11/66 (16.67%) 
Sinusitis †  7/69 (10.14%)  5/66 (7.58%) 
Influenza †  5/69 (7.25%)  2/66 (3.03%) 
Pharyngitis †  4/69 (5.80%)  3/66 (4.55%) 
Bronchitis †  1/69 (1.45%)  5/66 (7.58%) 
Rhinitis †  5/69 (7.25%)  1/66 (1.52%) 
Injury, poisoning and procedural complications     
Infusion related reaction †  8/69 (11.59%)  4/66 (6.06%) 
Contusion †  4/69 (5.80%)  1/66 (1.52%) 
Investigations     
Aspartate aminotransferase increased †  30/69 (43.48%)  4/66 (6.06%) 
Alanine aminotransferase increased †  18/69 (26.09%)  4/66 (6.06%) 
Blood alkaline phosphatase increased †  10/69 (14.49%)  2/66 (3.03%) 
Blood lactate dehydrogenase increased †  6/69 (8.70%)  1/66 (1.52%) 
Gamma-glutamyltransferase increased †  4/69 (5.80%)  0/66 (0.00%) 
Platelet count decreased †  4/69 (5.80%)  0/66 (0.00%) 
Weight increased †  0/69 (0.00%)  4/66 (6.06%) 
Metabolism and nutrition disorders     
Decreased appetite †  13/69 (18.84%)  11/66 (16.67%) 
Hypokalaemia †  12/69 (17.39%)  6/66 (9.09%) 
Musculoskeletal and connective tissue disorders     
Back pain †  19/69 (27.54%)  21/66 (31.82%) 
Arthralgia †  16/69 (23.19%)  20/66 (30.30%) 
Pain in extremity †  9/69 (13.04%)  15/66 (22.73%) 
Bone pain †  5/69 (7.25%)  15/66 (22.73%) 
Myalgia †  7/69 (10.14%)  12/66 (18.18%) 
Musculoskeletal pain †  9/69 (13.04%)  4/66 (6.06%) 
Muscle spasms †  4/69 (5.80%)  6/66 (9.09%) 
Musculoskeletal chest pain †  4/69 (5.80%)  3/66 (4.55%) 
Neck pain †  5/69 (7.25%)  2/66 (3.03%) 
Nervous system disorders     
Headache †  28/69 (40.58%)  12/66 (18.18%) 
Dysgeusia †  6/69 (8.70%)  15/66 (22.73%) 
Neuropathy peripheral †  10/69 (14.49%)  10/66 (15.15%) 
Peripheral sensory neuropathy †  5/69 (7.25%)  14/66 (21.21%) 
Paraesthesia †  6/69 (8.70%)  11/66 (16.67%) 
Dizziness †  3/69 (4.35%)  6/66 (9.09%) 
Hypoaesthesia †  4/69 (5.80%)  3/66 (4.55%) 
Psychiatric disorders     
Insomnia †  8/69 (11.59%)  12/66 (18.18%) 
Anxiety †  6/69 (8.70%)  5/66 (7.58%) 
Depression †  5/69 (7.25%)  4/66 (6.06%) 
Renal and urinary disorders     
Dysuria †  1/69 (1.45%)  4/66 (6.06%) 
Reproductive system and breast disorders     
Breast pain †  1/69 (1.45%)  8/66 (12.12%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  18/69 (26.09%)  14/66 (21.21%) 
Dyspnoea †  10/69 (14.49%)  18/66 (27.27%) 
Epistaxis †  19/69 (27.54%)  5/66 (7.58%) 
Oropharyngeal pain †  8/69 (11.59%)  8/66 (12.12%) 
Rhinorrhoea †  5/69 (7.25%)  4/66 (6.06%) 
Dyspnoea exertional †  1/69 (1.45%)  6/66 (9.09%) 
Skin and subcutaneous tissue disorders     
Alopecia †  3/69 (4.35%)  44/66 (66.67%) 
Rash †  12/69 (17.39%)  15/66 (22.73%) 
Nail disorder †  7/69 (10.14%)  16/66 (24.24%) 
Pruritus †  2/69 (2.90%)  8/66 (12.12%) 
Erythema †  2/69 (2.90%)  5/66 (7.58%) 
Acne †  6/69 (8.70%)  0/66 (0.00%) 
Dry skin †  4/69 (5.80%)  2/66 (3.03%) 
Palmar-plantar erythrodysaesthesia syndrome †  2/69 (2.90%)  4/66 (6.06%) 
Dermatitis †  1/69 (1.45%)  4/66 (6.06%) 
Nail discolouration †  0/69 (0.00%)  4/66 (6.06%) 
Vascular disorders     
Hypertension †  9/69 (13.04%)  6/66 (9.09%) 
Hot flush †  0/69 (0.00%)  10/66 (15.15%) 
Lymphoedema †  3/69 (4.35%)  5/66 (7.58%) 
Flushing †  2/69 (2.90%)  4/66 (6.06%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00679341    
Other Study ID Numbers: BO21976
TDM4450g ( Other Identifier: Genentech )
First Submitted: May 14, 2008
First Posted: May 16, 2008
Results First Submitted: February 22, 2013
Results First Posted: May 20, 2013
Last Update Posted: January 9, 2014