INVASIVE CARCINOMA OF THE BREAST: Complete Excision (Less Than Total Mastectomy, Including Specimens Designated Biopsy, Lumpectomy, Quadrantectomy, and Partial Mastectomy With or Without Axillary Contents) and Mastectomy (Total, Modified Radical, Radical With or Without Axillary Contents)

Specimen:
Partial breast
Total breast (including nipple and skin)
Other (specify):
Not specified

Procedure Type:
Excision without wire-guided localization
Excision with wire-guided localization
Total mastectomy (including nipple and skin)
Other (specify):
Not specified

Lymph Node Sampling:
   No lymph nodes present
   Sentinel lymph node(s)
   Axillary dissection (partial or complete dissection)
   Lymph nodes present within the breast specimen (ie, intramammary lymph nodes)
   Other lymph nodes (eg, supraclavicular or location not identified):

Specimen Integrity:
Single intact specimen (margins can be evaluated)
Multiple designated specimens (eg, main excision and identified margins)
Fragmented (margins cannot be evaluated with certainty)
Other (specify):

Specimen Size (for excisions less than total mastectomy):
       Greatest dimension (cm):
       Additional dimensions: x cm
       Cannot be determined

Specimen Laterality:
Right
Left
Not specified

Tumor Site: Invasive Carcinoma:
Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple

Position:
o’clock
Other (specify):
Not specified

Tumor Size: Size of Largest Invasive Carcinoma
   Microinvasion only (=0.1 cm)
   Greatest dimension of largest focus of invasion over 0.1 cm (cm):
   Additional dimensions: x cm
   No residual invasive carcinoma after presurgical (neoadjuvant) therapy
   Cannot be determined (see Comment)

Note: The size of the invasive carcinoma should take into consideration the gross findings correlated with the microscopic examination. In some cases, it may be helpful to use information about tumor size from imaging studies. If multiple foci of invasion are present, the size listed is the size of the largest contiguous area of invasion. The size of multiple invasive carcinomas should not be added together. The size does not include adjacent DCIS.
If there has been a prior core needle biopsy or incisional biopsy showing a larger area of invasion than in the excisional specimen, the largest dimension of the invasive carcinoma in the prior specimen should be used for T classification, if known.
If there has been prior treatment and no invasive carcinoma is present, the cancer is classified as Tis if there is residual DCIS and T0 if there is no remaining carcinoma.

Tumor Focality:
Single focus of invasive carcinoma
Multiple foci of invasive carcinoma: number and sizes
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Indeterminate

Note: If there are multiple invasive carcinomas, size, grade, histologic type, and the results of studies for estrogen receptor (ER), progesterone receptor (PR), and HER2/neu should pertain to the largest invasive carcinoma. If smaller invasive carcinomas differ in any of these features, this information may be included in the “Comments” section.

Macroscopic and Microscopic Extent of Tumor:

Skin:
Skin is not present
Invasive carcinoma does not invade into the dermis or epidermis
Invasive carcinoma directly invades into the dermis or epidermis without skin ulceration
Invasive carcinoma directly invades into the dermis or epidermis with skin ulceration (classified as T4b)
Satellite skin foci of invasive carcinoma are present (ie, not contiguous with the invasive carcinoma in the breast) (classified as T4b)

Nipple:
DCIS does not involve the nipple epidermis
DCIS involves nipple epidermis (Paget disease of the nipple) Note: This finding does not change the T classification.

Skeletal Muscle:
No skeletal muscle present
Skeletal muscle is present and is free of carcinoma
Carcinoma invades skeletal muscle
Carcinoma invades into skeletal muscle and into the chest wall (classified as T4a)

Note: Invasion into pectoralis muscle is not considered chest wall invasion, and cancers are not classified as T4a unless there is invasion deeper than this muscle.

Ductal Carcinoma In Situ (DCIS):
No DCIS is present
DCIS is present
Extensive intraductal component (EIC) negative
EIC positive
Only DCIS is present after presurgical (neoadjuvant) therapy

Size (Extent) of DCIS:
       Estimated size (extent) of DCIS (greatest dimension using gross and microscopic evaluation) is at least cm
       Additional dimensions: x cm
       Number of blocks with DCIS:
       Number of blocks examined:

Note: The size (extent) of DCIS is an estimation of the volume of breast tissue occupied by DCIS. This information may be helpful for cases with a predominant component of DCIS (eg, DCIS with microinvasion) but may not be necessary for cases of EIC negative invasive carcinomas.

Architectural Patterns:
   Comedo
   Paget disease (DCIS involving nipple skin)
   Cribriform
   Micropapillary
   Papillary
   Solid
   Other (specify):

Nuclear Grade:
Grade I (low)
Grade II (intermediate)
Grade III (high)

Necrosis:
Not identified
Present, focal (small foci or single cell necrosis)
Present, central (expansive “comedo” necrosis)

Lobular Carcinoma In Situ (LCIS):
Not identified
Present

Histologic Type of Invasive Carcinoma:
   Ductal carcinoma in situ with microinvasion
   Lobular carcinoma in situ with microinvasion
   Ductal carcinoma in situ involving nipple skin (Paget disease) with microinvasion
   Invasive ductal carcinoma (no special type or not otherwise specified)
   Invasive lobular carcinoma
   Invasive carcinoma with ductal and lobular features (“mixed type carcinoma”)
   Invasive mucinous carcinoma
   Invasive medullary carcinoma
   Invasive papillary carcinoma
   Invasive micropapillary carcinoma
   Invasive tubular carcinoma
   Invasive cribriform carcinoma
   Invasive carcinoma, type cannot be determined
   No residual invasive carcinoma after presurgical (neoadjuvant) therapy
   Other(s) (specify):

Note: The histologic type corresponds to the largest area of invasion. If there are smaller foci of invasion of a different type, this information should be included under “Additional Pathologic Findings.”

Histologic Grade: Nottingham Histologic Score

Glandular (Acinar)/Tubular Differentiation:
Score 1: >75% of tumor area forming glandular/tubular structures
Score 2: 10% to 75% of tumor area forming glandular/tubular structures
Score 3: <10% of tumor area forming glandular/tubular structures
Only microinvasion present (not graded)
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Score cannot be determined

Nuclear Pleomorphism:
Score 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size
Score 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape
Score 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms
Only microinvasion present (not graded)
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Score cannot be determined

Mitotic Count:
Score 1
Score 2
Score 3
Only microinvasion present (not graded)
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Score cannot be determined

Number of mitoses per 10 high-power fields:
Diameter of microscope field (mm):

Overall Grade:
Grade 1: scores of 3, 4, or 5
Grade 2: scores of 6 or 7
Grade 3: scores of 8 or 9
Only microinvasion present (not graded)
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Score cannot be determined.

Note: The grade corresponds to the largest area of invasion. If there are smaller foci of invasion of a different grade, this information should be included under “Additional Pathologic Findings.”

Margins:
   Margins cannot be assessed
   Margins uninvolved by invasive carcinoma, closest mm at :
       Distance from superior margin: mm
       Distance from inferior margin: mm
       Distance from anterior margin: mm
       Distance from posterior margin: mm
       Distance from medial margin: mm
       Distance from lateral margin: mm
       Distance from : mm
   Margins uninvolved by DCIS (if present), closest at :
       Distance from superior margin: mm
       Distance from inferior margin: mm
       Distance from anterior margin: mm
       Distance from posterior margin: mm
       Distance from medial margin: mm
       Distance from lateral margin: mm
       Distance from : mm
   Margin(s) positive for invasive carcinoma:
       Superior margin:
        Focal
        Minimal/moderate
        Extensive
       Inferior margin:
        Focal
        Minimal/moderate
        Extensive
       Anterior margin:
        Focal
        Minimal/moderate
        Extensive
       Posterior margin:
        Focal
        Minimal/moderate
        Extensive
       Medial margin:
        Focal
        Minimal/moderate
        Extensive
       Lateral margin :
        Focal
        Minimal/moderate
        Extensive
   Margin(s) positive for DCIS:
       Superior margin:
        Focal
        Minimal/moderate
        Extensive
       Inferior margin:
        Focal
        Minimal/moderate
        Extensive
       Anterior margin:
        Focal
        Minimal/moderate
        Extensive
       Posterior margin:
        Focal
        Minimal/moderate
        Extensive
       Medial margin:
        Focal
        Minimal/moderate
        Extensive
       Lateral margin :
        Focal
        Minimal/moderate
        Extensive

Treatment Effect: Response to Presurgical (Neoadjuvant) Therapy:
       In the Breast:
           No known presurgical therapy
           No definite response to presurgical therapy in the invasive carcinoma
           Probable or definite response to presurgical therapy in the invasive carcinoma
           No residual invasive carcinoma is present in the breast after presurgical therapy
       In the Lymph Nodes:
           No known presurgical therapy
           No lymph nodes removed
           No definite response to presurgical therapy in metastatic carcinoma
           Probable or definite response to presurgical therapy in metastatic carcinoma
           No lymph node metastases. Fibrous scarring, possibly related to prior lymph node metastases with pathologic complete response
           No lymph node metastases and no prominent fibrous scarring in the nodes

Lymph-Vascular Invasion:
    Not identified
    Present
    Indeterminate

Dermal Lymph-Vascular Invasion:
    No skin present
    Not identified
    Present
    Indeterminate

Lymph Nodes (required only if lymph nodes are present in the specimen):
       Number of sentinel lymph nodes examined:
       Total number of lymph nodes examined (sentinel and nonsentinel):
       Number of lymph nodes with macrometastases (>0.2 cm):
       Number of lymph nodes with micrometastases (>0.2 mm to 0.2 cm and/or >200 cells):
       Number of lymph nodes with isolated tumor cells (=0.2 mm and =200 cells):
       Size of largest metastatic deposit (if present) (cm):

Note: The sentinel node is usually the first involved lymph node. In the unusual situation in which a sentinel node is not involved by metastatic carcinoma, but a nonsentinel node is involved, this information should be included in a note.

Extranodal Extension:
    Present
    Not identified
    Indeterminate

Method of Evaluation of Sentinel Lymph Nodes:
       Hematoxylin and eosin (H&E), one level
       H&E, multiple levels
       Immunohistochemistry
       Sentinel lymph node biopsy not performed
       Other (specify):

Pathologic Staging (based on information available to the pathologist) (pTNM)

TNM Descriptors (required only if applicable)
m (multiple foci of invasive carcinoma)
r (recurrent)
y (posttreatment)

Primary Tumor (Invasive Carcinoma) (pT) :
pTX: Primary tumor cannot be assessed
pT0: No evidence of primary tumor
pTis (DCIS): Ductal carcinoma in situ
pTis (LCIS): Lobular carcinoma in situ
pTis (Paget): Paget disease of the nipple not associated with invasive carcinoma and/or carcinoma in situ (DCIS and/or LCIS) in the underlying breast parenchyma
pT1: Tumor =20 mm in greatest dimension
pT1mi: Tumor =1 mm in greatest dimension (microinvasion)
pT1a: Tumor >1 mm but =5 mm in greatest dimension
pT1b: Tumor >5 mm but =10 mm in greatest dimension
pT1c: Tumor >10 mm but =20 mm in greatest dimension
pT2: Tumor >20 mm but =50 mm in greatest dimension
pT3: Tumor >50 mm in greatest dimension
pT4: Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules). Note: Invasion of the dermis alone does not qualify as pT4.
pT4a: Extension to chest wall, not including only pectoralis muscle adherence/invasion
pT4b: Ulceration and/or ipsilateral satellite nodules and/or edema (including peau d’orange) of the skin which do not meet the criteria for inflammatory carcinoma
pT4c: Both T4a and T4b
pT4d: Inflammatory carcinoma

For the purposes of this checklist, pT0 and pTis should only be used in the setting of preoperative (neoadjuvant) therapy for which a previously diagnosed invasive carcinoma is no longer present after treatment.
Inflammatory carcinoma is a clinical-pathologic entity characterized by diffuse erythema and edema (peau d’orange) involving one-third or more of the skin of the breast. The skin changes are due to lymphedema caused by tumor emboli within dermal lymphatics, which may or may not be obvious in a small skin biopsy. However, a tissue diagnosis is still necessary to demonstrate an invasive carcinoma in the underlying breast parenchyma or at least in the dermal lymphatics, as well as to determine biological markers, such as ER, PR, and HER2 status. Tumor emboli in dermal lymphatics without the clinical skin changes described above do not qualify as inflammatory carcinoma. Locally advanced breast cancers directly invading the dermis or ulcerating the skin without the clinical skin changes and tumor emboli in dermal lymphatics also do not qualify as inflammatory carcinoma. Thus the term inflammatory carcinoma should not be applied to neglected locally advanced cancer of the breast presenting late in the course of a patient’s disease. The rare case that exhibits all the features of inflammatory carcinoma, but in which skin changes involve less than one-third of the skin, should be classified by the size and extent of the underlying carcinoma.

Regional Lymph Nodes (pN) (choose a category based on lymph nodes received with the specimen; immunohistochemistry and/or molecular studies are not required)

If internal mammary lymph nodes, infraclavicular nodes, or supraclavicular lymph nodes are included in the specimen, consult the AJCC Cancer Staging Manual1 for additional lymph node categories.

Modifier (required only if applicable)
(sn): Only sentinel node(s) evaluated. If 6 or more sentinel nodes and/or nonsentinel nodes are removed, this modifier should not be used.

Category (pN):
pNX: Regional lymph nodes cannot be assessed (eg, previously removed, or not removed for pathologic study)
pN0: No regional lymph node metastasis identified histologically
pN0 (i-): No regional lymph node metastases histologically, negative IHC
pN0 (i+): Malignant cells in regional lymph node(s) no greater than 0.2 mm and no more than 200 cells (detected by H&E or IHC including ITC)
pN0 (mol-): No regional lymph node metastases histologically, negative molecular findings (reverse transcriptase polymerase chain reaction RT-PCR)
pN0 (mol+): Positive molecular findings (RT-PCR), but no regional lymph node metastases detected by histology or IHC
pN1mi: Micrometastases (greater than 0.2 mm and/or more than 200 cells, but none greater than 2.0 mm).
pN1a: Metastases in 1 to 3 axillary lymph nodes, at least 1 metastasis greater than 2.0 mm
pN2a: Metastases in 4 to 9 axillary lymph nodes (at least 1 tumor deposit greater than 2.0 mm)
pN3a: Metastases in 10 or more axillary lymph nodes (at least 1 tumor deposit greater than 2.0 mm)

Note: Isolated tumor cell (ITC) clusters are defined as small clusters of cells not greater than 0.2 mm or single tumor cells, or a cluster of fewer than 200 cells in a single histologic cross-section. ITCs may be detected by routine histology or by immunohistochemical (IHC) methods. Nodes containing only ITCs are excluded from the total positive node count for purposes of N classification but should be included in the total number of nodes evaluated.
Approximately 1000 tumor cells are contained in a 3-dimensional 0.2-mm cluster. Thus, if more than 200 individual tumor cells are identified as single dispersed tumor cells or as a nearly confluent elliptical or spherical focus in a single histologic section of a lymph node, there is a high probability that more than 1000 cells are present in the node. In these situations, the node should be classified as containing a micrometastasis (pN1mi). Cells in different lymph node cross-sections or longitudinal sections or levels of the block are not added together; the 200 cells must be in a single node profile even if the node has been thinly sectioned into multiple slices. It is recognized that there is substantial overlap between the upper limit of the ITC and the lower limit of the micrometastasis categories because of inherent limitations in pathologic nodal evaluation and detection of minimal tumor burden in lymph nodes. Thus, the threshold of 200 cells in a single cross-section is a guideline to help pathologists distinguish between these 2 categories. The pathologist should use judgment regarding whether it is likely that the cluster of cells represents a true micrometastasis or is simply a small group of isolated tumor cells.

Distant Metastasis (M):
Not applicable
cM0(i+): No clinical or radiographic evidence of distant metastasis, but deposits of molecularly or microscopically detected tumor cells in circulating blood, bone marrow, or other nonregional nodal tissue that are =0.2 mm in a patient without symptoms or signs of metastasis
pM1: Distant detectable metastasis as determined by classic clinical and radiographic means and/or histologically proven >0.2 mm

Additional Pathologic Findings:

Ancillary Studies

Estrogen Receptor (immunohistochemical results on invasive carcinoma performed on this specimen or a prior core needle biopsy or incisional biopsy):
Performed on this specimen
Performed on another specimen:accession
Pending
Not performed
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Other (specify):

Results:
    Immunoreactive tumor cells present (=1%), Quantitation:
    Less than 1% immunoreactive cells present
    No immunoreactive tumor cells present
    Results unknown
    Other (specify):

Antibody vendor and clone:
Type of fixative (if other than neutral buffered formalin):

Progesterone Receptor (immunohistochemical results for invasive carcinoma performed on this specimen or a prior core needle biopsy or incisional biopsy):
Performed on this specimen
Performed on another specimen:accession number
Pending
Not performed
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Other (specify):

Results:
    Immunoreactive tumor cells present (=1%), Quantitation:
    Less than 1% immunoreactive cells present
    No immunoreactive tumor cells present
    Results unknown
    Other (specify):

Antibody vendor and clone:

HER2/neu (results for invasive carcinoma performed on this specimen or a prior core needle biopsy or incisional biopsy)

Immunoperoxidase Studies:
Performed on this specimen
Performed on another specimen:accession number
Pending
Not performed
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Other (specify):

Results:
    Negative (Score 0)
    Negative (Score 1+)
    Equivocal (Score 2+)
    Positive (Score 3+)
    Other, specify:
    Results unknown

Antibody vendor and clone:

Fluorescence In Situ Hybridization (FISH) for HER2/neu:
Performed on this specimen
Performed on another specimen:accession
Pending
Not performed
No residual invasive carcinoma after presurgical (neoadjuvant) therapy
Other (specify):

Results:
    Not amplified (HER2 gene copy <4.0 or ratio <1.8)
    Equivocal (HER2 gene copy 4.0 to 6.0 or ratio 1.8 to 2.2)
    Amplified (HER2 gene copy >6.0 or ratio >2.2):
           Average number of HER2 gene copies per cell:
           Average number of chromosome 17 per cell:
           Ratio:
    Results unknown
    Other (specify):

Name of assay:

Other Ancillary Studies (results for invasive carcinoma performed on this specimen or a prior core needle biopsy or incisional biopsy):
       Performed on this specimen
       Performed on another specimen:accession number
       Name of test:
       Results:

Microcalcifications:
    Not identified
    Present in DCIS
    Present in invasive carcinoma
    Present in non-neoplastic tissue
    Present in both carcinoma and non-neoplastic tissue

Patient History:
       The current clinical/radiologic breast findings for which this surgery is performed include:
           Palpable mass
           Radiologic finding:
               Mass or architectural distortion
               Calcifications
                Other (specify):
           Nipple discharge
           Other (specify):
           Prior history of breast cancer:Specify site, diagnosis, and prior treatment
           Prior presurgical (neoadjuvant) therapy for this diagnosis of invasive carcinomaSpecify type:

Comment(s):