Registration Header
Coordinating Group Protocol Number (N063D)
string
Coordinating Group Code (NCCTG)
string
Protocol Title (ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial)
string
Patient Medical Record Number
string
Participating Group Code
string
Are data amended (check one if data are amended, please circle in red when using paper form)
boolean
Unnamed 1
Pre-Registration Type
integer
First Submission
integer
Contact Person For Pathology Results
Last Name
string
First Name
string
Phone
string
Fax
string
string
Patient Demographics
Gender
integer
Date of Birth
date
ZIP Code
integer
Country of Residence
string
Method of Payment
integer
Race
integer
Ethnicity
integer
Eligibility Screening Form
Inclusion Criteria
integer
Exclusion criteria
integer
Randomization
Informed consent
Date Informed consent signed
date
Date of consent [for] pharmacogenetic research
date
Did the patient consent to donate blood sample
boolean
Did the patient consent to tumor tissue
boolean
Did the patient consent to donate additional blood sample
boolean
Did the patient consent to donate fresh/frozen tissue
boolean
Unnamed 1
Menopausal Status
integer
Date of last menstrual cycle
date
Date of pregnancy test
date
Pregnancy test
integer
Has the patient had a hysterectomy?
boolean
Hysterectomy
date
Unilateral ovariectomy/oophorectomy
boolean
Specify side
integer
Unilateral oophorectomy Date
date
Patient Status
Date of Physical exam
date
Physical exam
integer
Height
integer
Weight
integer
BSA
integer
Blood Pressure, systolic
integer
Blood Pressure, diastolic
integer
Heart Rate
integer
ECOG
integer
ECG
Cardiac Monitoring
Date of LVEF
date
LVEF
string
Echocardiogramm
boolean
Muga Scan
boolean
Result
integer
Symptomatic CHF
boolean
NYHA Classification
integer
Local Her2 Results
Staining Antibody
integer
other
string
ICH Result
integer
Percentage of invasive tumor cells with complete membrane staining
integer
FISH Kit or Test Type
integer
other
string
FISH Result
integer
FISH HER2/neu chromosome 17 Ratio
integer
Chromosome 17 copy number
integer
Sample test date
date
Not done
string
CISH Kit or Test Type
integer
Other
string
CISH Result
integer
Chromosome 17 copy number
integer
Hormonal Receptor Status
ER % cells stained positive
integer
PgR % cells stained positive
integer
History Of Primary Breast Cancer
Date of initial Pathologic Diagnosis
date
Tumor Laterality
integer
Clinical Size of Tumor
integer
Clinical N Stage
integer
Pathologic Primary Tumor Size
integer
Margin involvement
boolean
Histologic Type
integer
other
string
Is carcinoma in situ present
boolean
Histologic Type
integer
Is Paget's disease of the nipple present?
boolean
Histologic Grade
integer
Lymphnode involvement
integer
Timing of chemotherapy
integer
Hematology And Biochemistry
integer
Date of blood specimen collection
date
Result
integer
History Of Primary Cancer (continued)
Laboratory Name
string
ER status
integer
Is estrogen receptor analysis result available
boolean
Estrogen receptor value
integer
H-Score
integer
Allred-Score
integer
Remmle score
integer
other
string
Method
string
Range
string
PgR Status
integer
Is progesterone receptor analysis result available
boolean
Progesterone receptor value
integer
H-Score
integer
Allred-Score
integer
Remmle score
integer
other
string
Method
string
Range
string
Sentinel Node Sampling
Was sentinel node sampling performed
boolean
Sentinel Node Biopsy Date
date
Laterality
integer
Axillary sentinel node biopsy
integer
Internal sentinel mammary nodes biopsy
integer
Not done
string
Most Extensive Primary Surgery
Primary breast cancer surgery
integer
Specify
string
Laterality
integer
Primary surgery Date
date
Axilladissektion
Date of Axillary Dissection
date
Laterality
integer
Number of Lymph Nodes examinded
integer
Number positive Lymph nodes
integer
Largest tumor deposit
integer
Not done
string
Chemotherapy
Agent Name
string
Total Dose
integer
initial dose
integer
Total No. Cycles
integer
Prior Treatment Regimen Type
integer
Date Started
date
Date Stopped
date
Previous Or Current Cardiovascular Disease
Has the patient suffered cardiovascular disease?
boolean
Medical condition
string
Medical condition
integer
Treatment Required
boolean
Has the patient been assessed for systemic disease
boolean
ECG
Type of radiological Examination
integer
Specify
string
Anatomical Site
integer
Date of test
date
Are there any clinically significant abnormalites
boolean
Specify
string
Not done
string
Translational Research
Central Her2 Testing Form - FISH
Percentage greater than or equal to 3 Chromosome 17 signals
string
NACA (No apparent Chromosome 17 anomaly)
boolean
Why no result
integer
Specify
string
Other features
integer
Central Her2 Testing Form - IHC
Percentage of invasive tumor cells with complete membrane staining
integer
Uniformity of staining
integer
Homogeneous dark circumferential pattern
integer
IHC Result
integer
Is there vascular invasion
boolean
Suitable for TMA
boolean
Radiotherapy
prior Radiation Therapy
boolean
RT Site
string
Side
integer
RT Total Dose
integer
Dose UOM
integer
Radiation Therapy Start Date
date
Radiation Therapy End Date
date
Hormonetherapy
Has the patient received hormone therapy before or during the trial
boolean
Name of treatment or surgical procedure
string
Dose
integer
Unit
integer
Begin date
date
End date
date
ongoing at time of study completion
integer
Concomitant Treatment
Name of treatment
string
Indication for use
integer
Date started
date
Date stopped
date
Ongoing
integer
Administration of Study Drug
Date Agent Administered
date
Dose
integer
Total Dose
integer
Was treatment delayed
boolean
Specify code
integer
specify
string
Was dose reduced
boolean
Specify code
integer
specify
string
Post-Event-Treatment
Chemotherapy
Did the patient receive additional chemotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
boolean
Agent Name
string
Total No. Cycles
integer
initial dose
integer
Dose UOM
integer
Date started
date
Date stopped
date
Targeted Therapy
AdditionalTargetTherapy
boolean
Agent Name
string
Total No. Cycles
integer
initial dose
integer
Dose UOM
integer
Date started
date
Date stopped
date
Hormonetherapy
Did the patient receive hormone therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
boolean
Agent Name
string
Total No. Cycles
integer
initial dose
integer
Dose UOM
integer
Date started
date
Date stopped
date
Radiotherapy
Did the patient receive radiotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
boolean
Radiation Therapy Site
string
Side
integer
Total Dose
integer
Dose UOM
integer
Radiation Therapy Start Date
date
Radiation Therapy End Date
date
Surgery
Did the patient receive surgery after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
boolean
Surgical site
string
Surgery Date
date
Adverse Event (AE)
AE Name
integer
1024 more adverse events
integer
SAE reported
boolean
CTCAE Begin Date
date
CTCAE End Date
date
CTC Adverse Event Grade
integer
CTC Adverse Event Outcomme
integer
Action Taken at Time of Adverse Event
integer
relation to study drug
boolean
Second Primary Malignancy and Contralateral Breast Cancer
Type of recurrence
string
Date of First Recurrence or Progression
date
Method of Evaluation
integer
Biopsy
boolean
Biopsy Date
date
Specify other Histologic Type
string
On Study - Years 6, 7, 8, 9, and 10
Patient Status
Date of Physical Exam
date
Not done
string
Are there any changes since the previous assessment
boolean
Are there any changes since the previous assessment
integer
Date of last contact
date
ECOG Performance Status
integer
Blood Pressure, systolic
integer
Blood Pressure, diastolic
integer
Cardiac Monitoring
Date of LVEF
date
LVEF
string
Echocardiogram
boolean
MUGA Scan
boolean
Result
integer
Symptomatic CHF
boolean
New York Heart Association
integer
Mammogram
Mammogram
integer
Date of Test
date
Not done
string
Are there any clinically significant abnormalites
boolean
specify
string
Hematoly and Biochemistry
Survival Follow-Up
Vital Status
integer
Dead
date
Date of last contact
date
Investigator Signature
string
Date
date
Treatment Completion
Did the patient complete Lapatinib as per protocol
integer
Did the patient complete Trastuzumab as per protocol
integer
Did the patient complete Paclitaxel as per protocol
integer
Reasons for treatment discontinuation
integer
Date of last contact within treatment period
date
Additional Comments
CRF Page Number
integer
Comments
string
Investigator Signature
string
Date
date
Death Form
Date of Death
date
Primary Cause of death
integer
specify
string
Was autopsy performed
integer
Please summarize findings
string