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Long NameStaging, Breast NCI Standard Template
DefinitionThe collection of CDEs used in the breast staging module based on AJCC Edition 7.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3443146
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Breast Staging QuestionsThese items must be included when this data is collected for reporting.
Date Current Staging Assessment CompletedCurrent Stage Complete Assessment Date627393.0DATEMM/DD/YYYY
Conditional Breast Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Clinical T StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Tumor T Stage34193871.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
TXBreast Cancer pTX TNM FindingBreast cancer in which the primary tumor cannot be assessed. (from AJCC 6th and 7th Eds.)
T0Breast Cancer pT0 TNM FindingBreast cancer with no evidence of primary tumor. (from AJCC 6th and 7th Eds.)
TisBreast Cancer pTis TNM FindingBreast cancer with a finding of carcinoma in situ. (from AJCC 6th and 7th Eds.)
Tis (DCIS)Breast Cancer pTis (DCIS) TNM FindingBreast cancer with a finding of ductal carcinoma in situ. (from AJCC 6th Ed and 7th Ed.)
Tis (LCIS)Breast Cancer pTis (LCIS) TNM FindingBreast cancer with a finding of lobular carcinoma in situ. (from AJCC 6th Ed and 7th Ed.)
Tis (Paget's)Breast Cancer pTis Paget TNM FindingPaget disease of the nipple without invasive carcinoma and/or carcinoma in situ in the underlying breast parenchyma. (from AJCC 6th and 7th Ed.)
T1Breast Cancer pT1 TNM FindingBreast cancer with tumor size 2.0 cm or less in greatest dimension. (from AJCC 6th and 7th Ed.)
T1miBreast Cancer pT1mic TNM FindingBreast cancer with tumor size 0.1 cm or less in greatest dimension (microinvasion). (from AJCC 6th and 7th Eds.)
T1aBreast Cancer pT1a TNM FindingBreast cancer with tumor size more than 0.1 cm, but not more than 0.5 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T1bBreast Cancer pT1b TNM FindingBreast cancer with tumor size more than 0.5 cm, but not more than 1.0 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T1cBreast Cancer pT1c TNM FindingBreast cancer with tumor size more than 1.0 cm, but not more than 2.0 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T2Breast Cancer pT2 TNM FindingBreast cancer with tumor size more than 2.0 cm, but not more than 5.0 cm in greatest dimension. (from AJCC 6th Ed.)
T3Breast Cancer pT3 TNM FindingBreast cancer with tumor size more than 5.0 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T4Breast Cancer pT4 TNM FindingBreast cancer with tumor of any size with direct extension to chest wall or skin, but only as described in pT4 sub-categories, in accordance with TNM guidelines. (from AJCC 6th and 7th Eds.)
T4aBreast Cancer pT4a TNM FindingBreast cancer with extension to the chest wall, not including the pectoralis muscle. (from AJCC 6th and 7th Eds.)
T4bBreast Cancer pT4b TNM FindingBreast cancer with 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. (from AJCC 6th and 7th Eds.)
T4cBreast Cancer pT4c TNM FindingBreast cancer with extension to the chest wall, not including the pectoralis muscle, and with edema (including peau d'orange) or ulceration of the skin of the breast of satellite skin nodules confined to the same breast. (from AJCC 6th and 7th Eds.)
T4dBreast Cancer pT4d TNM FindingBreast cancer meeting the clinical-pathologic criteria of inflammatory carcinoma. (from AJCC 6th and 7th Eds.)
Clinical N StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Regional Lymph Node N Stage34193891.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
NXBreast Cancer cNX TNM FindingBreast cancer in which regional lymph nodes cannot be assessed. (from AJCC 6th and 7th Eds.)
N0Breast Cancer cN0 TNM FindingBreast cancer with no regional lymph node metastasis. (from AJCC 6th and 7th Eds.)
N1Breast Cancer cN1 TNM FindingBreast cancer with metastasis to movable ipsilateral level I, II axillary lymph node(s). (from AJCC 6th and 7th Eds.)
N2Breast Cancer cN2 TNM Finding v7Breast cancer with metastases in ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted; or in clinically detected ipsilateral internal mammary nodes in the absence of clinically evident axillary lymph node metastases. "Clinically detected" is defined as detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination and having characteristics highly suspicious for malignancy or a presumed pathologic macrometastasis based on fine needle aspiration biopsy with cytologic examination. (from AJCC 7th Ed.)
N2aBreast Cancer cN2a TNM FindingBreast cancer with metastases in ipsilateral level I, II axillary lymph nodes fixed to one another (matted) or to other structures. (from AJCC 6th and 7th Eds.)
N2bBreast Cancer cN2b TNM Finding v7Breast cancer with metastases only in clinically detected ipsilateral internal mammary nodes and in the absence of clinically evident level I, II axillary lymph node metastases. "Clinically detected" is defined as detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination and having characteristics highly suspicious for malignancy or a presumed pathologic macrometastasis based on fine needle aspiration biopsy with cytologic examination. (from AJCC 7th Ed.)
N3Breast Cancer cN3 TNM Finding v7Breast cancer with metastases in ipsilateral infraclavicular (level III) axillary lymph node(s) with or without level I, II axillary lymph node involvement; or in clinically detected ipsilateral internal mammary lymph node(s) with clinically evident level I, II axillary lymph node metastases; or metastases in ipsilateral supraclavicular lymph node(s) with or without axillary or internal mammary lymph node involvement. (from AJCC 7th Ed.)
N3aBreast Cancer cN3a TNM FindingBreast cancer with metastasis in ipsilateral infraclavicular lymph node(s). (from AJCC 6th and 7th Eds.)
N3bBreast Cancer cN3b TNM FindingBreast cancer with metastasis in ipsilateral internal mammary lymph node(s) and axillary lymph node(s). (from AJCC 6th and 7th Eds.)
N3cBreast Cancer cN3c TNM FindingBreast cancer with metastasis in ipsilateral supraclavicular lymph node(s). (from AJCC 6th and 7th Eds.)
Clinical M StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Distant Metastasis M Stage34193911.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M0Breast Cancer cM0 TNM Finding v7Breast cancer in which there is no clinical or radiographic evidence of distant metastases. (from AJCC 7th Ed.)
cM0(i+)Breast Cancer cM0(i+) TNM Finding v7Breast cancer in which there is no clinical or radiographic evidence of distant metastases, but deposits of molecularly or microscopically detected tumor cells in circulating blood, bone marrow, or other nonregional nodal tissue that are no larger than 0.2 mm in a patient without symptoms or signs of metastases. (from AJCC 7th Ed.)
M1Breast Cancer cM1 TNM Finding v7Breast cancer with distant detectable metastases as determined by classic clinical and radiographic means and/or histologically proven larger than 0.2 mm. (from AJCC 7th Ed.)
Pathologic T StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Tumor T Stage34193931.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
T0Breast Cancer pT0 TNM FindingBreast cancer with no evidence of primary tumor. (from AJCC 6th and 7th Eds.)
T1Breast Cancer pT1 TNM FindingBreast cancer with tumor size 2.0 cm or less in greatest dimension. (from AJCC 6th and 7th Ed.)
T1miBreast Cancer pT1mic TNM FindingBreast cancer with tumor size 0.1 cm or less in greatest dimension (microinvasion). (from AJCC 6th and 7th Eds.)
T1aBreast Cancer pT1a TNM FindingBreast cancer with tumor size more than 0.1 cm, but not more than 0.5 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T1bBreast Cancer pT1b TNM FindingBreast cancer with tumor size more than 0.5 cm, but not more than 1.0 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T1cBreast Cancer pT1c TNM FindingBreast cancer with tumor size more than 1.0 cm, but not more than 2.0 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T2Breast Cancer pT2 TNM FindingBreast cancer with tumor size more than 2.0 cm, but not more than 5.0 cm in greatest dimension. (from AJCC 6th Ed.)
T3Breast Cancer pT3 TNM FindingBreast cancer with tumor size more than 5.0 cm in greatest dimension. (from AJCC 6th and 7th Eds.)
T4Breast Cancer pT4 TNM FindingBreast cancer with tumor of any size with direct extension to chest wall or skin, but only as described in pT4 sub-categories, in accordance with TNM guidelines. (from AJCC 6th and 7th Eds.)
T4aBreast Cancer pT4a TNM FindingBreast cancer with extension to the chest wall, not including the pectoralis muscle. (from AJCC 6th and 7th Eds.)
T4bBreast Cancer pT4b TNM FindingBreast cancer with 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. (from AJCC 6th and 7th Eds.)
T4cBreast Cancer pT4c TNM FindingBreast cancer with extension to the chest wall, not including the pectoralis muscle, and with edema (including peau d'orange) or ulceration of the skin of the breast of satellite skin nodules confined to the same breast. (from AJCC 6th and 7th Eds.)
T4dBreast Cancer pT4d TNM FindingBreast cancer meeting the clinical-pathologic criteria of inflammatory carcinoma. (from AJCC 6th and 7th Eds.)
TXBreast Cancer pTX TNM FindingBreast cancer in which the primary tumor cannot be assessed. (from AJCC 6th and 7th Eds.)
TisBreast Cancer pTis TNM FindingBreast cancer with a finding of carcinoma in situ. (from AJCC 6th and 7th Eds.)
Tis (DCIS)Breast Cancer pTis (DCIS) TNM FindingBreast cancer with a finding of ductal carcinoma in situ. (from AJCC 6th Ed and 7th Ed.)
Tis (LCIS)Breast Cancer pTis (LCIS) TNM FindingBreast cancer with a finding of lobular carcinoma in situ. (from AJCC 6th Ed and 7th Ed.)
Tis (Paget's)Breast Cancer pTis Paget TNM FindingPaget disease of the nipple without invasive carcinoma and/or carcinoma in situ in the underlying breast parenchyma. (from AJCC 6th and 7th Ed.)
Pathologic N StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Regional Lymph Node N Stage34193951.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
NXBreast Cancer cNX TNM FindingBreast cancer in which regional lymph nodes cannot be assessed. (from AJCC 6th and 7th Eds.)
N0Breast Cancer cN0 TNM FindingBreast cancer with no regional lymph node metastasis. (from AJCC 6th and 7th Eds.)
N1Breast Cancer cN1 TNM FindingBreast cancer with metastasis to movable ipsilateral level I, II axillary lymph node(s). (from AJCC 6th and 7th Eds.)
N2Breast Cancer cN2 TNM Finding v7Breast cancer with metastases in ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted; or in clinically detected ipsilateral internal mammary nodes in the absence of clinically evident axillary lymph node metastases. "Clinically detected" is defined as detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination and having characteristics highly suspicious for malignancy or a presumed pathologic macrometastasis based on fine needle aspiration biopsy with cytologic examination. (from AJCC 7th Ed.)
N2aBreast Cancer cN2a TNM FindingBreast cancer with metastases in ipsilateral level I, II axillary lymph nodes fixed to one another (matted) or to other structures. (from AJCC 6th and 7th Eds.)
N2bBreast Cancer cN2b TNM Finding v7Breast cancer with metastases only in clinically detected ipsilateral internal mammary nodes and in the absence of clinically evident level I, II axillary lymph node metastases. "Clinically detected" is defined as detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination and having characteristics highly suspicious for malignancy or a presumed pathologic macrometastasis based on fine needle aspiration biopsy with cytologic examination. (from AJCC 7th Ed.)
N3Breast Cancer cN3 TNM Finding v7Breast cancer with metastases in ipsilateral infraclavicular (level III) axillary lymph node(s) with or without level I, II axillary lymph node involvement; or in clinically detected ipsilateral internal mammary lymph node(s) with clinically evident level I, II axillary lymph node metastases; or metastases in ipsilateral supraclavicular lymph node(s) with or without axillary or internal mammary lymph node involvement. (from AJCC 7th Ed.)
N3aBreast Cancer cN3a TNM FindingBreast cancer with metastasis in ipsilateral infraclavicular lymph node(s). (from AJCC 6th and 7th Eds.)
N3bBreast Cancer cN3b TNM FindingBreast cancer with metastasis in ipsilateral internal mammary lymph node(s) and axillary lymph node(s). (from AJCC 6th and 7th Eds.)
N3cBreast Cancer cN3c TNM FindingBreast cancer with metastasis in ipsilateral supraclavicular lymph node(s). (from AJCC 6th and 7th Eds.)
Pathologic M StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Distant Metastasis M Stage34194061.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
M1Breast Cancer pM1 TNM FindingBreast cancer with distant metastasis. (from AJCC 6th and 7th Eds.)
Disease StageBreast Cancer American Joint Committee on Cancer (AJCC) Edition 7 Group Stage34194071.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
0Stage 0 Breast CancerStage 0 includes: Tis, N0, M0. Tis: Carcinoma in situ. N0: No regional lymph node metastasis. M0: No distant metastasis. (AJCC 6th and 7th Eds.)
IAStage IA Breast CancerStage IA includes: T1, N0, M0. T1: Tumor 20 mm or less in greatest dimension. T1 includes T1mi. T1mi: Tumor 1 mm or less in greatest dimension. N0: No regional lymph node metastasis. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 7th Ed.)
IBStage IB Breast CancerStage IB includes: (T0, N1mi, M0); (T1, N1mi, M0). T0: No evidence of primary tumor. T1: Tumor 20 mm or less in greatest dimension. T1 includes T1mi. T1mi: Tumor 1 mm or less in greatest dimension. N1mi: Nodal micrometastases. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 7th Ed.)
IIAStage IIA Breast CancerStage IIA includes: (T0, N1, M0); (T1, N1, M0); (T2, N0, M0). T0: No evidence of primary tumor. T1: Tumor 20 mm or less in greatest dimension. T1 includes T1mi. T1mi: Tumor 1 mm or less in greatest dimension. T2: Tumor more than 20 mm but not more than 50 mm in greatest dimension. N1: Metastasis to movable ipsilateral level I, II axillary lymph node(s). N0: No regional lymph node metastasis. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 6th and 7th Eds.)
IIBStage IIB Breast CancerStage IIB includes: (T2, N1, M0); (T3, N0, M0). T2: Tumor more than 20 mm but not more than 50 mm in greatest dimension. T3: Tumor more than 50 mm in greatest dimension. N1: Metastasis to movable ipsilateral level I, II axillary lymph node(s). N0: No regional lymph node metastasis. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 6th and 7th Eds.)
IIIAStage IIIA Breast CancerStage IIIA includes: (T0, N2, M0); (T1, N2, M0); (T2, N2, M0); (T3, N1, M0); (T3, N2, M0). T0: No evidence of primary tumor. T1: Tumor 20 mm or less in greatest dimension. T1 includes T1mi. T1mi: Tumor 1 mm or less in greatest dimension. T2: Tumor more than 20 mm but not more than 50 mm in greatest dimension. T3: Tumor more than 50 mm in greatest dimension. N1: Metastasis to movable ipsilateral level I, II axillary lymph node(s). N2: Metastases in ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted; or in clinically detected ipsilateral internal mammary nodes in the absence of clinically evident axillary lymph node metastases. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 7th Ed.)
IIIBStage IIIB Breast CancerStage IIIB includes: (T4, N0, M0); (T4, N1, M0); (T4, N2, M0). T4: Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules). N0: No regional lymph node metastasis. N1: Metastasis to movable ipsilateral level I, II axillary lymph node(s). N2: Metastases in ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted; or in clinically detected ipsilateral internal mammary nodes in the absence of clinically evident axillary lymph node metastases. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 7th Ed.)
IIICStage IIIC Breast CancerStage IIIC includes: Any T, N3, M0. N3: Metastases in ipsilateral infraclavicular (level III) axillary lymph nodes(s) with or without level I, II axillary lymph node involvement; or in clinically detected ipsilateral internal mammary lymph node(s) with clinically evident level I, II axillary lymph node metastases; or metastases in ipsilateral supraclavicular lymph node(s) with or without axillary or internal mammary lymph node involvement. M0: No clinical or radiographic evidence of distant metastasis. M0 includes M0(i+). (AJCC 7th Ed.)
IVStage IV Breast CancerStage IV includes: Any T, Any N, M1. M1: Distant metastasis. (AJCC 6th and 7th Eds.)
Stage unknownStage UnknownA finding indicating that the extent of organ/tissue involvement by a malignant neoplasm is not reported or not assessed.
Optional Breast Staging QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Staging Time PointDisease Staging Timepoint Name28473521.0CHARACTER
Current DiagnosisCurrent DiagnosisOccurring in or belonging to the present time.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Initial DiagnosisFirst DiagnosisPreceding all others in time or space or degree.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
RestagingRestagingRepeat of staging assessment
Study EnrollmentClinical Study EnrollmentResearch conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials, epidemiology, behavior and health services research. : Enrollment; to insert, register, or enter in a list, catalog, or roll. (Merriam-Webster Online)