Invasive carcinoma of breast
Item
histologically or cytologically confirmed infiltrating breast cancer
boolean
C0853879 (UMLS CUI [1])
Neoplasm Metastasis Few | Metastatic Lesion Quantity | Primary tumor | Primary tumor Absent | Neoplasm Recurrence, Local | Secondary malignant neoplasm of lymph node Local-Regional | Axillary region | Parasternal region | Other Coding | Lesion Amenable Excision Curative | Lesion Amenable Therapeutic radiology procedure Curative | Staging Chest PET with concurrent CT | Staging PET/CT scan Abdomen | Staging Radioisotope scan of bone
Item
oligometastatic disease defined as one to three metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the axillary, parasternal, and ipsilateral periclavicular regions. all lesions must be amenable to resection or radiotherapy with curative intent. staging examinations must have included a pet-scan plus diagnostic ct-scan of the chest and abdomen, and an isotope bone scan. when the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, mri or ct-scan of the affected skeletal region must be performed.
boolean
C0027627 (UMLS CUI [1,1])
C0205388 (UMLS CUI [1,2])
C1513183 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3])
C0677930 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0027643 (UMLS CUI [5])
C0686619 (UMLS CUI [6,1])
C1947913 (UMLS CUI [6,2])
C0004454 (UMLS CUI [7])
C0458345 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C0221198 (UMLS CUI [10,1])
C3900053 (UMLS CUI [10,2])
C0728940 (UMLS CUI [10,3])
C1276305 (UMLS CUI [10,4])
C0221198 (UMLS CUI [11,1])
C3900053 (UMLS CUI [11,2])
C1522449 (UMLS CUI [11,3])
C1276305 (UMLS CUI [11,4])
C0332305 (UMLS CUI [12,1])
C2073389 (UMLS CUI [12,2])
C0332305 (UMLS CUI [13,1])
C1699633 (UMLS CUI [13,2])
C0000726 (UMLS CUI [13,3])
C0332305 (UMLS CUI [14,1])
C0203668 (UMLS CUI [14,2])
HER2 negative carcinoma of breast Immunohistochemistry | HER2 negative carcinoma of breast In Situ Hybridization
Item
the tumor must be her2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry).
boolean
C2316304 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C2316304 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])
Neoplasm Estrogen receptor positive Immunohistochemistry | Poorly differentiated carcinoma Grade
Item
the tumor must be er positive (≥ 10% nuclear staining at ihc) and poorly differentiated (grade 3).
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0741899 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Neoplasm Estrogen receptor negative | Neoplasm Progesterone receptor positive
Item
or er negative; the rare tumors that are er-negative and pgr-positive will be eligible, if this pattern of hormone receptor expression can be verified in the nki-avl reference pathology lab.
boolean
C0027651 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
BRCA1 gene mutation | BRCA2 gene mutation
Item
known brca1 or brca2 mutation carriers are eligible regardless of the estrogen receptor status of their tumor.
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
world health organisation (who) performance status 0 or 1
boolean
C1298650 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function (anc ≥ 1.0 x 109/l, platelets ≥ 100 x 109/l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
adequate hepatic function (alat, asat and bilirubin ≤ 2.5 times upper limit of normal)
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Renal function | Creatinine clearance measurement
Item
adequate renal function (creatinine clearance ≥ 60 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Multiple gated acquisition scanning
Item
lvef ≥ 50% measured by echocardiography or muga
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Absence Condition Interferes with Protocol Compliance | Interference Mental conditions Absent | Interference Factor Familial Absent | Interference Sociological Factors Absent | Interference Geographic Factors Absent
Item
absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0332197 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0521102 (UMLS CUI [2,1])
C0809986 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C1521761 (UMLS CUI [3,2])
C0241888 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0521102 (UMLS CUI [4,1])
C3850138 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0521102 (UMLS CUI [5,1])
C0017444 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Cancer Other | Exception Curative treatment Malignant Neoplasms | Exception Curative treatment Without Chemotherapy | Exception Curative treatment Without Therapeutic radiology procedure
Item
no malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0332288 (UMLS CUI [4,3])
C1522449 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
no current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Cancer treatment | Investigational New Drugs
Item
no concurrent anti-cancer treatment or investigational drugs
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])