I-SPY 1 TRIAL: ACRIN 6657
Data Dictionary for TCIA Shared Patient Clinical Variables, July 14, 2015
Data sheet is locked to protect from accidental changes. PW= UCSF6657
Subset of: Data Dictionary for Final, Verified Integrated Data File, March 1, 2011
UPDATESApril 6, 2016, Replaced Her2CommPos with Her2MostPos to agree with ACRIN statistical analysis for primary aim paper. Changed "ISPY ID" header to "SUBJECTID" for consistancy with training data set in BMMR
Variable NameVariable DescriptionFormat
SUBJECTIDI-SPY ID de-identifies a patient’s CALGB and ACRIN IDInteger
1001-1239
DataExtractDtDate clinical data was downloaded from the CALGB databaseDate format
mm/dd/yyyy
Patient Demographics
AgePatient AgeNumber
race_idPatient RaceNumber
1=Caucasian
3=African American
4=Asian
5=Native Hawaiian/Pacific Islander
6=American Indian/Alaskan Native
50=Multiple race
On-Study Data (Pre-Treatment)
ERposEstrogen Receptor Status (Allred Score or Community determined), pre-treatmentNumber
0=Negative
1=Positive
2=Indeterminate
PgRposProgesterone Receptor Status (Allred Score or Community determined), pre-treatmentNumber
0=Negative
1=Positive
2=Indeterminate
HR PosHormone Receptor Status, pre-treatmentNumber
0=Negative for both ER and PR
1=Positive if either ER or PR was Positive
2=Indeterminate if both ER and PR were Indeterminate
Her2MostPos (replaced Her2CommPos, 4/6/2016)Her2 Status, pre-treatment, adding in Central Her2 IHC results for missing Community StatusNumber
0=Negative
1=Positive
Blank= indeterminate or not done
HR_HER2_CATEGORY3-level HR/Her2 category pre-treatmentNumber
1=HR Positive, Her2 Negative
2=Her2 Positive
3=Triple Negative
HR_HER2_STATUS3-level HR/Her2 status pre-treatmentText
HRposHER2neg = HR Positive, Her2 Negative
HER2pos = Her2 Positive
TripleNeg =Triple Negative
BilateralCaDoes the patient have bilateral breast cancer prior to neoadjuvant therapy?Number
0=No
1=Yes
LateralityIndex Tumor LateralityNumber
1=Left
2=Right
Imaging Data
MRI LD:LD spans all disease present (inv & DCIS) even if there is intervening normal tissue, in mmNumber
BaselineTimepoint 1= baseline
1-3d ACTimepoint 2= 1-3days after start of AC
InterRegTimepoint 3= Inter-regimen
PreSurgTimepint 4= Pre-Surgery
Blank=not available
*Of Note: Clinical Response & Evaluation is to coincide with MRI schedule.
T1= Pre-Treatment/Baseline
T2 = Early Treatment Day1, cycle 2
T3= Inter-Regimen
T4= Prior to Surgery for Response evaluation form and sample Post-surgery