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Trial record 24 of 190 for:    Oral Cancer | ( Map: Mexico )

A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02748213
Recruitment Status : Completed
First Posted : April 22, 2016
Results First Posted : November 22, 2016
Last Update Posted : November 22, 2016
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: Xeloda
Drug: Taxotere
Drug: Herceptin
Enrollment 225
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity. Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Period Title: Overall Study
Started 113 112
Treated 112 110
Completed 0 [1] 0
Not Completed 113 112
Reason Not Completed
Withdrawal Prior to Treatment             1             2
Abnormal Laboratory Test             1             0
Adverse Event or Intercurrent Illness             5             11
Death             5             3
Insufficient Therapeutic Response             56             57
Violation of Selection Criteria             2             0
Protocol Violation             6             4
Refused Treatment*             6             6
Failure to Return             1             0
Not Specified             30             29
[1]
*The reason "Refused Treatment" also includes those who did not cooperate or withdrew consent.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere Total
Hide Arm/Group Description Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity. Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity. Total of all reporting groups
Overall Number of Baseline Participants 112 110 222
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) Population: All participants, according to randomization scheme, who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 110 participants 222 participants
52.7  (11.18) 51.6  (10.74) 52.1  (10.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 110 participants 222 participants
Female
112
 100.0%
110
 100.0%
222
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
Time Frame Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description:
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Overall Number of Participants Analyzed 112 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.5
(61.18 to 78.77)
72.7
(63.41 to 80.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Herceptin + Taxotere + Xeloda, Herceptin + Taxotere
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
-10.17 to 14.56
Estimation Comments The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.
2.Secondary Outcome
Title Percentage of Participants With Death or Disease Progression According to RECIST
Hide Description Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.
Time Frame Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description:
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Overall Number of Participants Analyzed 112 110
Measure Type: Number
Unit of Measure: percentage of participants
67.9 77.3
3.Secondary Outcome
Title Progression-Free Survival (PFS) According to RECIST
Hide Description Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Time Frame Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description:
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Overall Number of Participants Analyzed 112 110
Median (95% Confidence Interval)
Unit of Measure: months
17.9
(14 to 21)
12.8
(10 to 16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Herceptin + Taxotere + Xeloda, Herceptin + Taxotere
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0449
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.53 to 0.99
Estimation Comments Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.
4.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description The percentage of participants who died from any cause was reported.
Time Frame Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description:
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Overall Number of Participants Analyzed 112 110
Measure Type: Number
Unit of Measure: percentage of participants
35.7 41.8
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Time Frame Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description:
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Overall Number of Participants Analyzed 112 110
Median (95% Confidence Interval)
Unit of Measure: months
43.5
(40 to 50)
47.3 [1] 
(32 to NA)
[1]
The upper limit of the 95% CI was not reached due to an insufficient number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Herceptin + Taxotere + Xeloda, Herceptin + Taxotere
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4758
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.56 to 1.32
Estimation Comments HR calculated using Herceptin + Taxotere arm as reference.
6.Secondary Outcome
Title Duration of Response (DOR) According to RECIST
Hide Description Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.
Time Frame Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The "Number of Participants Analyzed" reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis.
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description:
Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
Overall Number of Participants Analyzed 78 80
Median (Full Range)
Unit of Measure: months
15.9
(2.4 to 64.7)
13.4
(2.1 to 55.1)
Time Frame Continuously during treatment (up to 66 months) and up to 28 days after last dose (up to 66 months overall)
Adverse Event Reporting Description Safety Population: All randomized participants, according to treatment actually received, who received at least one dose of study medication.
 
Arm/Group Title Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Hide Arm/Group Description Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity. Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
All-Cause Mortality
Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Affected / at Risk (%) Affected / at Risk (%)
Total   52/112 (46.43%)   51/110 (46.36%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  16/112 (14.29%)  26/110 (23.64%) 
Neutropenia * 1  7/112 (6.25%)  7/110 (6.36%) 
Anaemia * 1  1/112 (0.89%)  1/110 (0.91%) 
Cardiac disorders     
Cardiac failure * 1  1/112 (0.89%)  0/110 (0.00%) 
Coronary artery disease * 1  1/112 (0.89%)  0/110 (0.00%) 
Left ventricular dysfunction * 1  1/112 (0.89%)  0/110 (0.00%) 
Pericardial effusion * 1  0/112 (0.00%)  1/110 (0.91%) 
Endocrine disorders     
Hyperthyroidism * 1  1/112 (0.89%)  0/110 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  5/112 (4.46%)  0/110 (0.00%) 
Vomiting * 1  3/112 (2.68%)  1/110 (0.91%) 
Rectal haemorrhage * 1  0/112 (0.00%)  1/110 (0.91%) 
Stomatitis * 1  1/112 (0.89%)  0/110 (0.00%) 
General disorders     
Pyrexia * 1  3/112 (2.68%)  4/110 (3.64%) 
Oedema peripheral * 1  1/112 (0.89%)  1/110 (0.91%) 
Chest pain * 1  0/112 (0.00%)  1/110 (0.91%) 
Hyperthermia * 1  1/112 (0.89%)  0/110 (0.00%) 
Inflammation of wound * 1  0/112 (0.00%)  1/110 (0.91%) 
Mucosal inflammation * 1  0/112 (0.00%)  1/110 (0.91%) 
Pitting oedema * 1  0/112 (0.00%)  1/110 (0.91%) 
Hepatobiliary disorders     
Acute hepatic failure * 1  0/112 (0.00%)  1/110 (0.91%) 
Cholelithiasis * 1  1/112 (0.89%)  0/110 (0.00%) 
Jaundice * 1  1/112 (0.89%)  0/110 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  0/112 (0.00%)  1/110 (0.91%) 
Infections and infestations     
Neutropenic sepsis * 1  5/112 (4.46%)  1/110 (0.91%) 
Bronchopneumonia * 1  3/112 (2.68%)  0/110 (0.00%) 
Central line infection * 1  2/112 (1.79%)  1/110 (0.91%) 
Cellulitis * 1  2/112 (1.79%)  0/110 (0.00%) 
Lower respiratory tract infection * 1  1/112 (0.89%)  0/110 (0.00%) 
Lymphangitis * 1  0/112 (0.00%)  1/110 (0.91%) 
Neutropenic infection * 1  0/112 (0.00%)  1/110 (0.91%) 
Oral candidiasis * 1  1/112 (0.89%)  0/110 (0.00%) 
Pneumonia * 1  1/112 (0.89%)  0/110 (0.00%) 
Postoperative wound infection * 1  1/112 (0.89%)  0/110 (0.00%) 
Pyelonephritis * 1  0/112 (0.00%)  1/110 (0.91%) 
Pyelonephritis acute * 1  0/112 (0.00%)  1/110 (0.91%) 
Respiratory tract infection * 1  1/112 (0.89%)  0/110 (0.00%) 
Skin infection * 1  0/112 (0.00%)  1/110 (0.91%) 
Tuberculosis * 1  1/112 (0.89%)  0/110 (0.00%) 
Urinary tract infection * 1  1/112 (0.89%)  0/110 (0.00%) 
Wound sepsis * 1  0/112 (0.00%)  1/110 (0.91%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  1/112 (0.89%)  0/110 (0.00%) 
Investigations     
Ejection fraction decreased * 1  0/112 (0.00%)  3/110 (2.73%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/112 (0.89%)  0/110 (0.00%) 
Hypoalbuminaemia * 1  0/112 (0.00%)  1/110 (0.91%) 
Hypocalcaemia * 1  0/112 (0.00%)  1/110 (0.91%) 
Metabolic acidosis * 1  1/112 (0.89%)  0/110 (0.00%) 
Musculoskeletal and connective tissue disorders     
Joint swelling * 1  1/112 (0.89%)  0/110 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukemia * 1  0/112 (0.00%)  1/110 (0.91%) 
Nervous system disorders     
Diplegia * 1  1/112 (0.89%)  0/110 (0.00%) 
Dizziness * 1  1/112 (0.89%)  0/110 (0.00%) 
Neuropathy * 1  0/112 (0.00%)  1/110 (0.91%) 
Psychiatric disorders     
Neurosis * 1  1/112 (0.89%)  0/110 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia * 1  1/112 (0.89%)  0/110 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  6/112 (5.36%)  0/110 (0.00%) 
Dyspnoea * 1  2/112 (1.79%)  3/110 (2.73%) 
Asthma * 1  0/112 (0.00%)  1/110 (0.91%) 
Bronchospasm * 1  1/112 (0.89%)  0/110 (0.00%) 
Pulmonary oedema * 1  1/112 (0.89%)  0/110 (0.00%) 
Vascular disorders     
Haemorrhage * 1  1/112 (0.89%)  0/110 (0.00%) 
Hypovolaemic shock * 1  0/112 (0.00%)  1/110 (0.91%) 
Thrombophlebitis * 1  1/112 (0.89%)  0/110 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Herceptin + Taxotere + Xeloda Herceptin + Taxotere
Affected / at Risk (%) Affected / at Risk (%)
Total   112/112 (100.00%)   107/110 (97.27%) 
Blood and lymphatic system disorders     
Neutropenia * 1  35/112 (31.25%)  23/110 (20.91%) 
Anaemia * 1  15/112 (13.39%)  19/110 (17.27%) 
Leukopenia * 1  10/112 (8.93%)  10/110 (9.09%) 
Febrile neutropenia * 1  3/112 (2.68%)  6/110 (5.45%) 
Eye disorders     
Lacrimation increased * 1  25/112 (22.32%)  22/110 (20.00%) 
Conjunctivitis * 1  15/112 (13.39%)  14/110 (12.73%) 
Dry eye * 1  7/112 (6.25%)  7/110 (6.36%) 
Vision blurred * 1  3/112 (2.68%)  6/110 (5.45%) 
Gastrointestinal disorders     
Diarrhoea * 1  75/112 (66.96%)  55/110 (50.00%) 
Nausea * 1  61/112 (54.46%)  39/110 (35.45%) 
Vomiting * 1  37/112 (33.04%)  30/110 (27.27%) 
Constipation * 1  29/112 (25.89%)  23/110 (20.91%) 
Stomatitis * 1  29/112 (25.89%)  19/110 (17.27%) 
Abdominal pain * 1  25/112 (22.32%)  16/110 (14.55%) 
Dyspepsia * 1  22/112 (19.64%)  12/110 (10.91%) 
Abdominal pain upper * 1  13/112 (11.61%)  5/110 (4.55%) 
Gastritis * 1  6/112 (5.36%)  4/110 (3.64%) 
Haemorrhoids * 1  8/112 (7.14%)  1/110 (0.91%) 
Odynophagia * 1  6/112 (5.36%)  1/110 (0.91%) 
General disorders     
Asthenia * 1  35/112 (31.25%)  35/110 (31.82%) 
Oedema peripheral * 1  28/112 (25.00%)  42/110 (38.18%) 
Fatigue * 1  35/112 (31.25%)  29/110 (26.36%) 
Mucosal inflammation * 1  34/112 (30.36%)  30/110 (27.27%) 
Pyrexia * 1  25/112 (22.32%)  19/110 (17.27%) 
Chest pain * 1  9/112 (8.04%)  10/110 (9.09%) 
Chills * 1  10/112 (8.93%)  9/110 (8.18%) 
Oedema * 1  3/112 (2.68%)  15/110 (13.64%) 
Pain * 1  6/112 (5.36%)  8/110 (7.27%) 
Infections and infestations     
Nasopharyngitis * 1  15/112 (13.39%)  12/110 (10.91%) 
Rhinitis * 1  13/112 (11.61%)  11/110 (10.00%) 
Influenza * 1  13/112 (11.61%)  10/110 (9.09%) 
Urinary tract infection * 1  8/112 (7.14%)  11/110 (10.00%) 
Investigations     
Weight decreased * 1  7/112 (6.25%)  1/110 (0.91%) 
Metabolism and nutrition disorders     
Anorexia * 1  23/112 (20.54%)  19/110 (17.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  28/112 (25.00%)  28/110 (25.45%) 
Myalgia * 1  15/112 (13.39%)  38/110 (34.55%) 
Back pain * 1  14/112 (12.50%)  15/110 (13.64%) 
Bone pain * 1  15/112 (13.39%)  10/110 (9.09%) 
Musculoskeletal pain * 1  10/112 (8.93%)  10/110 (9.09%) 
Pain in extremity * 1  9/112 (8.04%)  11/110 (10.00%) 
Musculoskeletal chest pain * 1  6/112 (5.36%)  2/110 (1.82%) 
Nervous system disorders     
Headache * 1  20/112 (17.86%)  28/110 (25.45%) 
Paraesthesia * 1  11/112 (9.82%)  20/110 (18.18%) 
Dizziness * 1  12/112 (10.71%)  16/110 (14.55%) 
Dysgeusia * 1  17/112 (15.18%)  11/110 (10.00%) 
Neuropathy peripheral * 1  13/112 (11.61%)  14/110 (12.73%) 
Peripheral sensory neuropathy * 1  10/112 (8.93%)  13/110 (11.82%) 
Neuropathy * 1  11/112 (9.82%)  11/110 (10.00%) 
Lethargy * 1  8/112 (7.14%)  13/110 (11.82%) 
Neurotoxicity * 1  6/112 (5.36%)  5/110 (4.55%) 
Psychiatric disorders     
Insomnia * 1  10/112 (8.93%)  12/110 (10.91%) 
Depression * 1  4/112 (3.57%)  10/110 (9.09%) 
Anxiety * 1  4/112 (3.57%)  8/110 (7.27%) 
Renal and urinary disorders     
Dysuria * 1  8/112 (7.14%)  6/110 (5.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  20/112 (17.86%)  18/110 (16.36%) 
Dyspnoea * 1  13/112 (11.61%)  19/110 (17.27%) 
Pharyngolaryngeal pain * 1  11/112 (9.82%)  13/110 (11.82%) 
Epistaxis * 1  10/112 (8.93%)  7/110 (6.36%) 
Rhinorrhoea * 1  5/112 (4.46%)  9/110 (8.18%) 
Dyspnoea exertional * 1  6/112 (5.36%)  5/110 (4.55%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  76/112 (67.86%)  68/110 (61.82%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  57/112 (50.89%)  7/110 (6.36%) 
Nail disorder * 1  28/112 (25.00%)  20/110 (18.18%) 
Rash * 1  22/112 (19.64%)  18/110 (16.36%) 
Onycholysis * 1  20/112 (17.86%)  14/110 (12.73%) 
Erythema * 1  13/112 (11.61%)  10/110 (9.09%) 
Skin reaction * 1  15/112 (13.39%)  4/110 (3.64%) 
Pruritus * 1  8/112 (7.14%)  8/110 (7.27%) 
Dry skin * 1  9/112 (8.04%)  6/110 (5.45%) 
Skin hyperpigmentation * 1  10/112 (8.93%)  3/110 (2.73%) 
Nail toxicity * 1  4/112 (3.57%)  6/110 (5.45%) 
Onychomadesis * 1  6/112 (5.36%)  2/110 (1.82%) 
Vascular disorders     
Hot flush * 1  9/112 (8.04%)  14/110 (12.73%) 
Lymphoedema * 1  8/112 (7.14%)  13/110 (11.82%) 
Phlebitis * 1  6/112 (5.36%)  4/110 (3.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02748213     History of Changes
Other Study ID Numbers: MO16419
First Submitted: April 20, 2016
First Posted: April 22, 2016
Results First Submitted: June 15, 2016
Results First Posted: November 22, 2016
Last Update Posted: November 22, 2016