A Dose-Finding Study of Subcutaneous Herceptin (Trastuzum... | NCT00800436 | Trialant
NCT00800436
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Dec 16, 2016Estimated
Enrollment
66Actual
Phase
Phase 1
Conditions
Breast Cancer
Interventions
Herceptin
Countries
Australia
New Zealand
Protocol Section
Identification Module
NCT ID
NCT00800436
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP22023
Secondary IDs
Not provided
Brief Title
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
Official Title
An Open-Label, Two-Part, Multi-Centre, Trastuzumab Dose-Finding Study in Healthy Male Volunteers and HER2 Positive Female Patients
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Oct 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
Oct 2009Actual
Completion Date
Oct 2009Actual
First Submitted Date
Dec 1, 2008
First Submission Date that Met QC Criteria
Dec 1, 2008
First Posted Date
Dec 2, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2016
Results First Submitted that Met QC Criteria
Oct 24, 2016
Results First Posted Date
Dec 16, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 24, 2016
Last Update Posted Date
Dec 16, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants. The study will also assess the safety and tolerability of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram [mg/kg] IV in healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants); Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK) parameter values cannot be used to define the target SC dose level. In Part 2 of the study, HER2-positive female participants will receive a single dose of SC Herceptin at the dose level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first (Part 1) dose.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
66Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Cohort 1
Experimental
Healthy male participants will receive Herceptin 6 mg/kg IV on Day 1.
Drug: Herceptin
Part 1: Cohort 2
Experimental
Female participants with HER2-positive breast cancer will receive Herceptin 6 mg/kg IV on Day 1.
Drug: Herceptin
Part 1: Cohort 3
Experimental
Healthy male participants will receive Herceptin 6 mg/kg SC on Day 1.
Drug: Herceptin
Part 1: Cohort 4
Experimental
Healthy male participants will receive Herceptin 10 mg/kg SC on Day 1.
Drug: Herceptin
Part 1: Cohort 5
Experimental
Healthy male participants will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohorts 1, 2, 3, and 4.
Drug: Herceptin
Part 2: Cohort A
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Herceptin
Drug
Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1.
Part 1: Cohort 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab
AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).
Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Secondary Outcomes
Measure
Description
Time Frame
Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab
CDay22 of trastuzumab was derived from the single PK collection on Day 22 and expressed in micrograms per milliliter (μg/mL).
Day 22
Maximum Observed Serum Concentration of Trastuzumab (Cmax)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy Participants (Part 1 only)
Males 18 to 45 to years of age
Baseline left ventricular ejection fraction (LVEF) greater than (>) 60 percent (%)
HER2-Positive Females (Parts 1 and 2)
Females greater than or equal to (≥) 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0
Previous non-metastatic operable primary invasive HER2-positive breast cancer
Baseline LVEF >55%
Exclusion Criteria:
Healthy Participants (Part 1 only)
Clinically significant abnormalities in laboratory test results or electrocardiogram
History of significant allergies, gastrointestinal, renal, hepatic, cardiovascular, or pulmonary disease
History of hypersensitivity or allergic reaction, spontaneous or following drug administration
History of cardiac conditions
HER2-Positive Females (Parts 1 and 2)
Metastatic disease
Concurrent other malignancy requiring therapy of any modality which may interfere with PK investigations or result in unexpected toxicity
Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B. Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol. 2013 Feb;53(2):192-201. doi: 10.1177/0091270012436560.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Four participants were counted twice as they were treated in both Cohort 2 and Cohort A.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1.
FG001
Part 1: Cohort 2
Female participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Female participants with HER2-positive breast cancer will receive Herceptin SC at the dose level determined in Part 1.
Drug: Herceptin
Part 2: Cohort B
Experimental
Female participants with HER2-positive breast cancer will receive Herceptin SC at an adjusted dose level based on preliminary PK analysis of Cohort A.
Drug: Herceptin
Part 1: Cohort 2
Part 1: Cohort 3
Part 1: Cohort 4
Part 1: Cohort 5
Part 2: Cohort A
Part 2: Cohort B
Trastuzumab
Cmax of trastuzumab was derived across all post-dose PK collections and expressed in μg/mL.
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Time to Maximum Serum Concentration (Tmax) of Trastuzumab
Tmax of trastuzumab was based on the Cmax derived across all post-dose PK collections and expressed in hours.
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Terminal Elimination Half-Life (T1/2) of Trastuzumab
T1/2 of trastuzumab was measured as the time required for trastuzumab concentration to decrease by one-half. T1/2 was derived across all PK collections and expressed in hours.
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
Christchurch
8011
New Zealand
Grafton
1150
New Zealand
FG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg subcutaneously (SC) on Day 1.
FG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
FG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
FG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
FG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG00520 subjects
FG00620 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0025 subjects
FG0035 subjects
FG0046 subjects
FG00520 subjects
FG00620 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Safety Population: All participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. The "Total" column (n=70) includes 4 female participants who were counted twice as they were treated in both Cohort 2 and Cohort A.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
BG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
BG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
BG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
BG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
BG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
BG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0026
BG0036
BG0046
BG00520
BG00620
BG00770
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00022.7± 2.58
BG00146.2± 5.19
BG00225.7± 9.29
BG003
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab
AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).
PK Population: All enrolled participants who adhered to the protocol (per protocol basis).
Posted
Mean
Standard Deviation
days•μg/mL
Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
ID
Title
Description
OG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
OG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
OG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
OG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
OG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
OG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
OG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001610± 303
OG0011800± 250
OG0021350± 320
OG003
Secondary
Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab
CDay22 of trastuzumab was derived from the single PK collection on Day 22 and expressed in micrograms per milliliter (μg/mL).
PK Population
Posted
Mean
Standard Deviation
μg/mL
Day 22
ID
Title
Description
OG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
OG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
OG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
OG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
OG004
Part 1: Cohort 5
Secondary
Maximum Observed Serum Concentration of Trastuzumab (Cmax)
Cmax of trastuzumab was derived across all post-dose PK collections and expressed in μg/mL.
PK Population
Posted
Mean
Standard Deviation
μg/mL
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
ID
Title
Description
OG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
OG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
OG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
OG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
Secondary
Time to Maximum Serum Concentration (Tmax) of Trastuzumab
Tmax of trastuzumab was based on the Cmax derived across all post-dose PK collections and expressed in hours.
PK Population
Posted
Median
Full Range
hours
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
ID
Title
Description
OG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
OG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
OG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
OG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
Secondary
Terminal Elimination Half-Life (T1/2) of Trastuzumab
T1/2 of trastuzumab was measured as the time required for trastuzumab concentration to decrease by one-half. T1/2 was derived across all PK collections and expressed in hours.
PK Population
Posted
Mean
Standard Deviation
hours
Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)
ID
Title
Description
OG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
OG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
OG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
OG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
Time Frame
From Baseline up to 5 months post-dose (up to 5 months overall)
Description
Analysis Population Description: Safety Population
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Cohort 1
Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
0
6
5
6
EG001
Part 1: Cohort 2
Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
0
6
6
6
EG002
Part 1: Cohort 3
Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
0
6
5
6
EG003
Part 1: Cohort 4
Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
0
6
5
6
EG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
0
6
6
6
EG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
0
20
19
20
EG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
0
20
20
20
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0041 affected6 at risk
EG0052 affected20 at risk
EG0063 affected20 at risk
Injection site erythema
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Injection site discolouration
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Catheter site haematoma
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Injection site pain
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Infusion related reaction
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Injection site swelling
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Application site inflammation
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Application site reaction
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Application site vesicles
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Catheter site erythema
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Feeling cold
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gravitational oedema
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Inflammation
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Injection site discomfort
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Injection site reaction
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Catheter site inflammation
General disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0012 affected6 at risk
EG0022 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Restless leg syndrome
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract Infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Viral infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Paronychia
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Athralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Joint crepitation
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Dysponea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Nasal congestation
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pharyngeal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Eye irritation
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Conjuctival haemorrhage
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Eyelid bleeding
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Scleral hypermia
Eye disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 12.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 12.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffmann-La Roche
800-821-8590
genentech@druginfo.com
ID
Term
D001943
Breast Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068878
Trastuzumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
23.0
± 6.16
BG00422.0± 4.34
BG00550.7± 7.21
BG00651.6± 9.04
BG00741.2± 14.85
0
BG0030
BG0040
BG00520
BG00620
BG00746
Male
BG0006
BG0010
BG0026
BG0036
BG0046
BG0050
BG0060
BG00724
6
OG0046
OG00520
OG00620
2500
± 515
OG0041960± 244
OG0052090± 638
OG0063550± 982
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
OG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
OG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG00520
OG00620
Title
Denominators
Categories
Title
Measurements
OG00025.6± 12.1
OG00127.5± 7.5
OG00231.6± 12.0
OG00351.4± 15.8
OG00439.4± 5.5
OG00537.8± 10.4
OG00660.8± 22.0
OG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
OG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
OG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG00520
OG00620
Title
Denominators
Categories
Title
Measurements
OG000150± 14.4
OG001185± 42.9
OG00266.8± 11.4
OG003102± 17.2
OG00482.0± 11.3
OG00588.4± 33.3
OG006151± 58.6
OG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
OG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
OG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG00520
OG00620
Title
Denominators
Categories
Title
Measurements
OG0001.65(1.6 to 24.0)
OG0013.00(1.55 to 24.0)
OG002156.00(95.95 to 216.10)
OG003132.12(96.00 to 216.00)
OG00496.00(96.00 to 215.98)
OG00597.13(47.93 to 216.60)
OG00696.05(24.53 to 241.40)
OG004
Part 1: Cohort 5
Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
OG005
Part 2: Cohort A
Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
OG006
Part 2: Cohort B
Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.