Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Breast Carcinoma
Item
female patients with breast cancer confirmed by histology.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Tumor tissue sample Available | Blood specimen Available
Item
tumour and blood samples according to appendix i available.
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0178913 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Age | Elderly Physical Fitness Adequate Chemotherapy
Item
age 18 years or older. elderly patients in condition adequate for chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0001792 (UMLS CUI [2,1])
C0031812 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
Breast Carcinoma Primary Localized | Inflammatory Breast Carcinoma Suitable First line treatment | Secondary malignant neoplasm of lymph node regional | Secondary malignant neoplasm of supraclavicular lymph nodes Ipsilateral Associated with Breast Carcinoma | Breast Carcinoma Lesion
Item
localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases including ipsilateral supraclavicular nodes with breast cancer diagnosis confirmed by histological examination with or without breast tumour lesions.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0392752 (UMLS CUI [1,3])
C0278601 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1708063 (UMLS CUI [2,3])
C0686619 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
C0686637 (UMLS CUI [4,1])
C0441989 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0678222 (UMLS CUI [4,4])
C0678222 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
Bone Marrow function | Renal function | Liver function | Cardiac function | Disease Uncontrolled Absent | Mental disorders Uncontrolled Absent
Item
adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
ECOG performance status
Item
ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
patients in child-bearing age with adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Distant metastasis | Secondary malignant neoplasm of lymph node Region of breast Contralateral | Secondary malignant neoplasm of lymph node Mediastinum
Item
distant metastases, including node metastases in the contralateral breast region and in the mediastina.
boolean
C1269798 (UMLS CUI [1])
C0686619 (UMLS CUI [2,1])
C0230109 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0686619 (UMLS CUI [3,1])
C0025066 (UMLS CUI [3,2])
Cancer Other | Exception Radical therapy Basal cell carcinoma | Exception Radical therapy Squamous cell carcinoma of skin | Exception Radical therapy Carcinoma in situ of uterine cervix
Item
other malignancy for the last two years except for radically treated basal or squamous cell carcinoma of the skin or cis of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0260176 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0260176 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0260176 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
HER2 gene amplification FISH
Item
her2-amplification verified by fish analysis.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Uncontrolled hypertension | Heart Diseases | Liver diseases | Kidney Diseases | Disease | Mental disorders
Item
uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
boolean
C1868885 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0012634 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
Thromboembolism | Anticoagulants Dose Full
Item
recent history of thromboembolism and ongoing medication with full-dose anticoagulants.
boolean
C0040038 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443225 (UMLS CUI [2,3])
Major surgery | Incisional biopsy | Traumatic injury | Major surgery Patient need for
Item
major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment.
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Minor Surgical Procedures | Insertion Indwelling Catheter | bevacizumab
Item
minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
boolean
C0038904 (UMLS CUI [1])
C0021107 (UMLS CUI [2,1])
C0007439 (UMLS CUI [2,2])
C0796392 (UMLS CUI [3])
Congenital bleeding diathesis | Hereditary coagulopathy Associated with Bleeding Risk
Item
history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
boolean
C1856452 (UMLS CUI [1])
C0679428 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
non-healing wound | Peptic Ulcer | Bone fracture
Item
non-healing wound, active peptic ulcer or bone fracture.
boolean
C0750433 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment.
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])