National Cancer Institute U.S. National Institutes of Health www.cancer.gov
Cancer Diagnosis Program (CDP)
CDP Tissue Microarrays

Data Manual for Breast Tissue Microarrays

Prognostic TMAs

Data variable Description: Coding:
Age Age at initial diagnosis Integer or blank
Year Year of initial diagnosis Integer or blank
Primary Histology Most prominent Histologic type 01 = Ductal (NOS)
08 = Lobular
Secondary Histology Secondary Histologic type (if any) 00 = None
01 = Ductal (NOS)
02 = Tubular
03 = Papillary
04 = Mucinous
05 = Medullary
06 = Cribiform
07 = Adenoid Cystic
08 = Lobular
09 = Mixed Lobular/Ductal
88 = Other, specify
Laterality of primary breast cancer Origin of the primary breast cancer 1 = Right
2 = Left
9 = Unknown
T Stage AJCC (version 5) T stage Stage I/II/III Prognostic TMAs:
T1 = Tumor < 20 mm
T1a = Tumor < 5 mm
T1b = Tumor > 5 mm and <10 mm
T1c = Tumor > 10 mm and < 20 mm

Stage II/III Prognostic TMAs only:
T2 = Tumor > 20 mm and < 50 mm
T3 = Tumor > 50 mm

Stage III Prognostic TMA only:
T4 = Tumor any size + extension
T4a = Extension to chest wall
T4b = Edema or ulceration or satellite skin nodules
T4c = Both T4a and T4b
T4d = Inflammatory carcinoma
N Stage AJCC (version 5) N stage Stage I/II/III Prognostic TMAs:
N0 = No evidence of regional LN involvement

Stage II/III Prognostic TMAs only:
N1 = Mets to movable, ipsilateral node
N1a = Only micromets (< 2 mm)
N1b = Any nodal mets > 2 mm
N1b1 = Mets to 1-3 nodes, any > 2 mm and all <20 mm
N1b2 = Mets to 4 or more nodes, any > 2 mm and all < 20 mm
N1b3 = Extension of tumor beyond node capsule, < 20 mm
N1b4 = Mets to nodes > 20 mm

Stage III Prognostic TMA only:
N2 = Mets to ipsilateral nodes that are fixed to one another or to other structures
N3 = Mets to ipsilateral internal mammary lymph node
NX = Minimum requirement not met (unknown)
M Stage AJCC (version 5) M stage M0 = No known distant metastases
Tumor Size Measurement (in cm) of the longest diameter of the tumor Integer or blank
Number of Nodes Positive Number of nodes positive at initial diagnosis 00 = All nodes negative
01-96 = Number of nodes positive
97 = 97 or more nodes positive
98 = Positive nodes, number unspecified
99 = Unknown if nodes positive or negative
Number of Nodes Examined Number of nodes examined at initial diagnosis 00 = No nodes examined
01-96 = Number of nodes examined
97 = 97 or more nodes examined
98 = Nodes examined, number unspecified
99 = Unknown if nodes examined
Type of Surgery Type of the most comprehensive procedure performed as part of the initially planned surgery 00 = Biopsy, NOS
10 = Partial Mastectomy WITHOUT Axillary Lymph Node Dissection
20 = Partial Mastectomy WITH Axillary Lymph Node Dissection
30 = SubQ Mastectomy WITH OR WITHOUT Axillary Lymph Node Dissection
40 = Mastectomy WITHOUT Axillary LymphNode Dissection
50 = Mastectomy WITH Axillary LymphNode Dissection
60 = Radical Mastectomy WITH Dissection of Majority of Pectoralis Major WITH Axillary LymphNode Dissection
90 = Mastectomy, NOS
Tubule Formation Percentage of tubular structures 1 = > 75 %
2 = > 10 to > 75 %
3 = < 10%
Nuclear Pleomorphism Qualitative and quantitative evaluations of the nuclei 1 = When the tumor cell nuclei are small with regular outlines, vary little in size and have uniform nuclear chromatin
2 = When the tumor cell nuclei are larger than normal, have open vesicular nuclei with visible nucleoli and have a moderate variability in size and shape
3 = When nuclei show marked variation is size and shape, especially when there are bizarre shapes, and/or prominent enlarged or multiple nucleoli
Mitotic Counts Mitotic counts are to be performed at the periphery of the tumor. Ten high power fields are counted.
Field area in mm2:
  0.152 0.175 0.200 0.225 0.250 0.275
1= 0-5 0-7 0-7 0-7 0-8 0-9
2= 6-10 7-12 8-13 8-15 9-17 10-18
3= >10 >12 >13 >15 >17 >18
Tumor Grade Total score calculated from the extent of tubule formation, nuclear pleomorphism, and mitotic count. 1 = Grade I
2 = Grade II
3 = Grade III
Chemotherapy Performed as part of initial, planned anti-cancer therapy. 0 = No
1 = Yes
Radiation therapy Performed as part of initial, planned anti-cancer therapy. 0 = No
1 = Yes
Hormone therapy Performed as part of initial, planned anti-cancer therapy. 0 = No
1 = Yes
Immunotherapy Performed as part of initial, planned anti-cancer therapy. 0 = No
1 = Yes
Other Therapy Performed as part of initial, planned anti-cancer therapy. 0 = No
1 = Yes
Vital Status Vital status at last contact 1 = Alive
2 = Dead
Length of follow-up for overall survival (OS) Number of months from date of diagnosis to date of death due to any cause, or to date last known alive. Integer or blank
Cancer status at death (if deceased) Any evidence of the breast cancer at the time of death. 0 = No evidence of breast cancer
1 = Evidence of this primary breast cancer (includes never disease-free, recurrent or metastatic cancer from primary).
2 = Another cancer is present, or the cancer present is of undetermined origin.
9 = Unknown
Type/site of first recurrence (if any) outside of ipsilateral breast The first recurrence outside of the ipsilateral breast. Applicable only if patient was disease free after initial surgery. 0 = None
1 = Chest wall (local)
2 = Ipsilateral axillary nodes or within the axilla if no nodes are mentioned (regional)
3 = Distant (includes distant nodes)
4 = Never disease-free
5 = Non-ipsilateral breast recurrence, but type/site not specified
6 = Recurred, but unknown if in ipsilateral breast or not in ipsilateral
Site of distant recurrence Site of distant recurrence, if any. Applicable only if patient was disease free after initial surgery. 01 = Skin
02 = Lymph Nodes
03 = Bone
04 = Lung
05 = Pleura
06 = Liver
07 = CNS
08 = Peritoneum
88 = Other
99 = Unknown
NA = Not applicable
Length of follow-up for first recurrence outside of ipsilateral breast Number of months from date of diagnosis to date of first recurrence outside of the ipsilateral breast. Integer or blank
Indicator of ipsilateral breast recurrence Ipsilateral breast recurrence. Applicable only if surgery was breast-conserving and patient was disease free following initial surgery. 0 = No
1 = Yes
NA = not applicable
Length of follow-up for ipsilateral breast recurrence Number of months from date of diagnosis to date of first ipsilateral in-breast recurrence, or to date last verified free of ipsilateral recurrence. Integer or NA
Type of first recurrence-free survival (RFS) event observed First observed RFS event (ipsilateral invasive breast tumor recurrence, local/regional recurrence, distant recurrence, death due to any cause, or none). Applicable only if patient was disease free after initial surgery. 1 = Death due to any cause
2 = Distant recurrence
3 = Ipsilateral recurrence
4 = Local/regional recurrence
5 = None
6 = Unknown
Length of follow-up for recurrence-free survival (RFS) Number of months from date of diagnosis to the date of first ipsilateral invasive breast tumor recurrence, local/regional recurrence, distant recurrence, or death due to any cause. Applicable only if patient was disease free after initial surgery. Integer or blank
ER Score ASCO CAP Guidelines for ER Scoring. 0 = Negative (< 1% expressing cells)
1 = Positive (= 1% expressing cells)
NA = Not applicable
PR Score ASCO CAP Guidelines for PR Scoring. 0 = Negative (< 1% expressing cells)
1 = Positive (= 1% expressing cells)
NA = Not applicable
HER2 IHC ASCO CAP Guidelines for HER2 Scoring. 0 = No staining
1 = Weak, incomplete membrane staining in any proportion of invasive tumor cells, or weak, complete membrane staining in less than 10% of cells.
2 = Complete membrane staining that is non-uniform or weak but with obvious circumferential distribution in at least 10% of cells, or intense complete membrane staining in 30% or less of tumor cells.
3 = Uniform intense membrane staining of more than 30% of invasive tumor cells.
NA = Not applicable
HER2 FISH ASCO CAP Guidelines for HER2 Scoring. 0 = Not amplified
1 = Amplified
HER2 Score Final HER2 result that is a combination of the HER2 IHC and FISH evaluations. HER2 FISH was performed for all 1+ and 2+ HER2 IHC results. 0 = Negative:
    IHC Score 0; or
    IHC Score 1+ or 2+ and HER2 not amplified with FISH
1 = Positive:
    IHC score 3+; or
    IHC Score 1+ or 2+ and HER2 amplified with FISH
Comments Information known about prior or subsequent primary cancers (breast or non-breast) and their recurrences (if any), and any other information pertinent to the interpretation of the case's data. Text or blank