A Study of Trastuzumab-MCC-DM1 Administered Intravenously... | NCT00932373 | Trialant
NCT00932373
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Aug 26, 2015Estimated
Enrollment
54Actual
Phase
Phase 1
Conditions
Metastatic Breast Cancer
Interventions
trastuzumab-MCC-DM1
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00932373
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TDM3569g
Secondary IDs
Not provided
Brief Title
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
Official Title
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Trastuzumab-MCC-DM1 (PRO132365) Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 2015
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
Apr 2006
Primary Completion Date
Jun 2009Actual
Completion Date
Jun 2009Actual
First Submitted Date
Jun 30, 2009
First Submission Date that Met QC Criteria
Jul 2, 2009
First Posted Date
Jul 3, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 1, 2015
Results First Submitted that Met QC Criteria
Jul 2, 2015
Results First Posted Date
Jul 30, 2015Estimated
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
Aug 13, 2015
Last Update Posted Date
Aug 26, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.
Detailed Description
Not provided
Conditions Module
Conditions
Metastatic Breast Cancer
Keywords
HER2-positive breast cancer
MBC
Trastuzumab emtansine
Herceptin
T-DM1
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
54Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Drug: trastuzumab-MCC-DM1
Interventions
Name
Type
Description
Arm Group Labels
Other Names
trastuzumab-MCC-DM1
Drug
Intravenous escalating dose
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment
The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
Study treatment initiation until 30 or 90 days after last administration of study treatment
Number of Patients With Dose Limiting Toxicities (DLTs)
DLT is defined as one of the following as per investigator related to study drug:
Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity
Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging
Grade ≥ 4 thrombocytopenia
Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever
Grade ≥ 4 anemia
Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.
Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22
A minimum of 21 days after first dose of trastuzumab-MCC-DM1
Maximum Tolerated Dose (MTD)
The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.
A minimum of 21 days after first dose of trastuzumab-MCC-DM1
Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an Objective Response
The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. 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 of the longest diameter of target lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically documented, incurable, locally advanced or metastatic breast cancer
Evaluable or measurable HER2-positive disease
History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer
Serum bilirubin ≤ 1.5 mg/dL; AST, ALT, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST ≤ 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN
Serum creatinine ≤ 1.5 mg/dL or creatinine clearance of ≥ 60 mL/min based on a 24-hour urine collection
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment
Exclusion Criteria:
History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication
History of Grade ≥ 3 hypersensitivity reaction to trastuzumab
History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued
Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment
Require supplemental oxygen for daily activities
Grade ≥ 2 peripheral neuropathy
Bisphosphonate therapy for symptomatic hypercalcemia
Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment
Any experimental therapy within 4 weeks of first study treatment
Any major surgical procedure within 4 weeks of first study treatment
History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis
Pregnancy or lactation
Cardiac troponin I ≥ 0.2 ng/mL
Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan
Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent
Beeram M, Krop IE, Burris HA, Girish SR, Yu W, Lu MW, Holden SN, Modi S. A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer. Cancer. 2012 Dec 1;118(23):5733-40. doi: 10.1002/cncr.27622. Epub 2012 May 30.
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
Two patients enrolled but discontinued the study prior to receiving study treatment drug, thus 52 patients received at least one dose and are included in the baseline and safety analysis data.
Recruitment Details
Approximately four centers in the United States were to participate in the study to enroll approximately 50-60 patients. Between 25 April 2006 and 20 May 2008, 54 patients were enrolled and 52 were treated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
FG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
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
Single Group 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
3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations
3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
Baseline to the end of the study (up to 3 years 2 months)
Duration of Objective Response
Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.
Baseline to the end of the study (up to 3 years 2 months)
Progression-free Survival
Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease 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 of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Baseline to the end of the study (up to 3 years 2 months)
Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine
After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.
Baseline to the end of the study (up to 3 years 2 months)
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
FG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
FG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
FG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
FG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
FG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
FG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
FG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
FG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
FG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG00415 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG00916 subjects
FG0103 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0093 subjects
FG0100 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG00414 subjects
FG0053 subjects
FG0061 subjects
FG0073 subjects
FG0082 subjects
FG00913 subjects
FG0103 subjects
Type
Comment
Reasons
Progressive disease
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG00410 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0099 subjects
FG0102 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Dose limiting toxicity
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Clinical progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All summaries were based on data from the safety population (patients who received at least one dose of Trastuzumab-MCC-DM1). All summaries were presented for all patients and by dose level and schedule.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
BG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
BG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
BG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
BG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
BG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
BG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
BG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
BG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
BG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
BG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0011
BG0021
BG0031
BG00415
BG0053
BG0063
BG0073
BG0083
BG00916
BG0103
BG01152
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
BG00060.7± 10.1
BG00147.0± 0
BG00261.0± 0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0011
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
Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment
The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.
Safety-evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1
Posted
Number
percentage of participants
Study treatment initiation until 30 or 90 days after last administration of study treatment
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
OG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0003
OG0011
OG0021
OG003
Title
Denominators
Categories
At least 1 AE
Title
Measurements
OG000100
OG001100
OG002100
OG003
Secondary
Percentage of Participants With an Objective Response
The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. 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 of the longest diameter of target lesions.
Efficacy population: All enrolled participants who received treatment.
Posted
Number
percentage of participants
Baseline to the end of the study (up to 3 years 2 months)
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Secondary
Duration of Objective Response
Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.
Efficacy population: All enrolled participants who received treatment.
Posted
Median
95% Confidence Interval
Months
Baseline to the end of the study (up to 3 years 2 months)
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG003
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
Secondary
Progression-free Survival
Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease 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 of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Efficacy population: All enrolled participants who received treatment.
Posted
Median
95% Confidence Interval
Months
Baseline to the end of the study (up to 3 years 2 months)
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
Secondary
Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine
After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.
Posted
Number
percentage of participants
Baseline to the end of the study (up to 3 years 2 months)
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 Every Weeks
Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
Units
Counts
Participants
Primary
Number of Patients With Dose Limiting Toxicities (DLTs)
DLT is defined as one of the following as per investigator related to study drug:
Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity
Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging
Grade ≥ 4 thrombocytopenia
Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever
Grade ≥ 4 anemia
Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.
Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22
Safety Population included all treated patients
Posted
Number
participants
A minimum of 21 days after first dose of trastuzumab-MCC-DM1
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
Primary
Maximum Tolerated Dose (MTD)
The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.
Safety evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1
Posted
Number
mg/kg
A minimum of 21 days after first dose of trastuzumab-MCC-DM1
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 Every Weeks
Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
Units
Counts
Participants
OG000
Primary
Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations
Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.
Posted
Mean
Standard Deviation
μg/mL
3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
OG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Primary
PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations
Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.
Posted
Mean
Standard Deviation
day • μg/mL
3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
OG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Primary
PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.
Posted
Mean
Standard Deviation
day
3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18
ID
Title
Description
OG000
Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
OG001
Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
OG003
Time Frame
Baseline to the end of the study (up to 3 years 2 months)
Description
Not provided
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
Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks
1
3
3
3
EG001
Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks
1
1
1
1
EG002
Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks
0
1
1
1
EG003
Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks
0
1
1
1
EG004
Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks
3
15
15
15
EG005
Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks
2
3
3
3
EG006
Trastuzumab-MCC-DM 1.2 mg/kg Weekly
Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week
1
3
3
3
EG007
Trastuzumab-MCC-DM 1.6 mg/kg Weekly
Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week
1
3
3
3
EG008
Trastuzumab-MCC-DM 2.0 mg/kg Weekly
Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week
1
3
3
3
EG009
Trastuzumab-MCC-DM 2.4 mg/kg Weekly
Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week
8
16
15
16
EG010
Trastuzumab-MCC-DM 2.9 mg/kg Weekly
2.9 mg/kg administered intravenously (IV) once a week
0
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected16 at risk
EG0100 events0 affected3 at risk
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Brain Oedema
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hepatic Encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary Hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ORAL PAIN
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG0030 affected1 at risk
EG0040 affected15 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected3 at risk
EG0090 affected16 at risk
EG0100 affected3 at risk
ALANINE AMINOTRANSFERASE
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
JOINT SPRAIN
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected1 at risk
EG0020 affected1 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
PATHOLOGICAL FRACTURE
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
PERIORBITAL OEDEMA
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected1 at risk
EG0020 affected1 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DISORIENTATION
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected1 at risk
EG0020 affected1 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
TUMOUR NECROSIS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DRY EYE
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
RETCHING
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected1 at risk
EG0020 affected1 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
FLUID RETENTION
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
CHEST PAIN
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
FATIGUE
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
FLUSHING
Vascular disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
CHILLS
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
PYREXIA
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
MENSTRUAL DISORDER
Reproductive system and breast disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
ANAEMIA
Blood and lymphatic system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
ANOREXIA
Metabolism and nutrition disorders
MedDRA (12.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected1 at risk
EG0021 affected1 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
EYE PAIN
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected1 at risk
EG0020 affected1 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
ASTHENIA
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
RALES
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected1 at risk
EG0020 affected1 at risk
EG003
COLD SWEAT
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
FACIAL PAIN
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
FACE OEDEMA
General disorders
MedDRA (12.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (12.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected1 at risk
EG0020 affected1 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
Genentech, Inc.
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
D000080044
Ado-Trastuzumab Emtansine
Ancestor Terms
ID
Term
D008453
Maytansine
D018942
Macrolides
D007783
Lactones
D009930
Organic Chemicals
D047029
Lactams, Macrocyclic
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
D000068878
Trastuzumab
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
2 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0092 subjects
FG0101 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
58.0
± 0
BG00452.1± 10.3
BG00548.0± 6.0
BG00655.3± 10.0
BG00753.0± 6.1
BG00855.3± 3.2
BG00950.9± 14.0
BG01058.3± 11.0
BG01152.9± 10.7
1
BG0031
BG00415
BG0053
BG0063
BG0073
BG0083
BG00916
BG0103
BG01152
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
1
BG0031
BG00415
BG0053
BG0063
BG0073
BG0083
BG00916
BG0103
BG01152
1
OG00415
OG0053
OG0063
OG0073
OG0083
OG00916
OG0103
100
OG004100
OG005100
OG006100
OG007100
OG008100
OG009100
OG010100
AEs with Grade >=3
Title
Measurements
OG00033.3
OG001100
OG0020
OG0030
OG00446.7
OG005100
OG00633.3
OG00766.7
OG00866.7
OG00981.3
OG01033.3
At least 1 SAE
Title
Measurements
OG00033.3
OG001100
OG0020
OG0030
OG00420
OG00566.7
OG00633.3
OG00733.3
OG00833.3
OG00950
OG0100
AEs related to treatment
Title
Measurements
OG00066.7
OG001100
OG002100
OG003100
OG00493.3
OG005100
OG006100
OG00766.7
OG008100
OG00987.5
OG010100
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
OG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0003
OG0011
OG0021
OG0031
OG00415
OG0053
OG0063
OG0073
OG0083
OG00916
OG0103
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003100
OG00426.7
OG0050
OG006100
OG00766.7
OG00866.7
OG00937.5
OG0100
OG004
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG005
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0001
OG0014
OG0023
OG0032
OG0042
OG0056
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable as the median and/or confidence interval limits were not reached.
OG00110.5(4.2 to 10.5)
OG002NA(NA to NA)Not estimable as the median and/or confidence interval limits were not reached.
OG0032.9(NA to NA)Not estimable as the median and/or confidence interval limits were not reached.
OG004NA(NA to NA)Not estimable as the median and/or confidence interval limits were not reached.
OG0055.6(4.5 to NA)Not estimable as the median and/or confidence interval limits were not reached.
OG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0003
OG0011
OG0021
OG0031
OG00415
OG0053
OG0063
OG0073
OG0083
OG00916
OG0103
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.3 to 4.2)
OG0011.7(NA to NA)Not Estimable
OG002NA(NA to NA)Not Estimable
OG003NA(NA to NA)Not Estimable
OG00410.4(3.4 to 17.1)
OG005NA(0.7 to NA)Not Estimable
OG006NA(20.8 to NA)Not Estimable
OG0074.5(1.6 to NA)Not Estimable
OG008NA(7.2 to NA)Not Estimable
OG0095.7(1.3 to 10.9)
OG0102.0(1.3 to 2.8)
OG00024
OG00128
Title
Denominators
Categories
Pre-dose (Cycle 1, Day 1)
Title
Measurements
OG0000.0
OG0013.7
Any Visit after Dosing
Title
Measurements
OG0004.3
OG0010.0
OG002
Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
OG003
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0003
OG0011
OG0021
OG0031
OG00415
OG0053
OG0063
OG0073
OG0083
OG00916
OG0103
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
OG0060
OG0070
OG0080
OG0091
OG0102
24
OG00128
Title
Denominators
Categories
Title
Measurements
OG0003.6
OG0012.4
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0003
OG0011
OG0021
OG0031
OG00415
OG0053
OG0063
OG0073
OG0083
OG00916
OG0103
Title
Denominators
Categories
Title
Measurements
OG0009.63± 1.73
OG00113.3± 0
OG00220.3± 0
OG00376.3± 0
OG00476.2± 19.1
OG005130± 7.77
OG00629.6± 5.66
OG00734.3± 4.81
OG00848.0± 9.56
OG00954.8± 12.6
OG01078.1± 33.9
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
Units
Counts
Participants
OG0003
OG0011
OG0021
OG0031
OG00415
OG0053
OG0063
OG0073
OG0083
OG00916
OG0103
Title
Denominators
Categories
Title
Measurements
OG00014.5± 3.39
OG00124.5± 0
OG00242.9± 0
OG003330± 0
OG004300± 65.8
OG005673± 12.2
OG00676.2± 10.4
OG007130± 39.7
OG008175± 41.0
OG009199± 54.5
OG010212± 39.0
Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
OG004
Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
OG005
Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks
Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
OG006
Trastuzumab-MCC-DM1 1.2 mg/kg Weekly
Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
OG007
Trastuzumab-MCC-DM1 1.6 mg/kg Weekly
Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
OG008
Trastuzumab-MCC-DM1 2.0 mg/kg Weekly
Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
OG009
Trastuzumab-MCC-DM1 2.4 mg/kg Weekly
Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
OG010
Trastuzumab-MCC-DM1 2.9 mg/kg Weekly
Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week