Breast Carcinoma epithelial | TNM category
Item
1. all patients must have a diagnosis of epithelial breast carcinoma which is, according to tnm classification:
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0809869 (UMLS CUI [2])
T - Tumor stage
Item
any t
boolean
C0475455 (UMLS CUI [1])
N+ (tumor staging) | N Stage | lymph nodes
Item
with positive (n+) or negative (n-) lymph-node depending on the patient profile
boolean
C0441922 (UMLS CUI [1])
C0456532 (UMLS CUI [2])
C0024204 (UMLS CUI [3])
M0 category
Item
and non metastatic (m0)
boolean
C0445034 (UMLS CUI [1])
Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization | Chromogenic in situ Hybridization | American Society of Clinical Oncology diagnostic criteria
Item
2. her2/neu-negative (immunohistochemical expression "0-1+", and/or fish/cish "non amplified" according to asco 2012 criteria)
boolean
C2316304 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
C1516514 (UMLS CUI [4])
C1515948 (UMLS CUI [5,1])
C0679228 (UMLS CUI [5,2])
First line treatment Population Group | High risk of Relapse
Item
3. first line treatment population with a high-risk of relapse as defined by:
boolean
C1708063 (UMLS CUI [1,1])
C1257890 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
lymph node positive | Operative Surgical Procedures Primary | Lymph node positive (1-3 positive nodes) pN1mi category | Neoadjuvant Therapy Chemotherapy | Anthracyclines | Taxanes, antineoplastic
Item
with at least 4 positive lymph nodes (ln) at primary surgery, or at least one positive lymph node >pn1mi after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
boolean
C0746319 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C4035698 (UMLS CUI [3,1])
C2732831 (UMLS CUI [3,2])
C0600558 (UMLS CUI [4,1])
C3665472 (UMLS CUI [4,2])
C0282564 (UMLS CUI [5])
C3541958 (UMLS CUI [6])
Triple-Negative Breast Cancer Finding | Lymph node positive (1-3 positive nodes) pN1mi category | Negative Lymph Node | In complete remission | Invasive Carcinoma persistent | Neoadjuvant Therapy Chemotherapy | Anthracyclines | Taxanes, antineoplastic
Item
or, negative hormone receptors: er- and pr- , (<10%), i.e "triple negative breast cancer" with at least one positive lymph node >pn1mi or negative lymph node if a pathological complete remission was not achieved (persistence of invasive carcinoma) after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
boolean
C2348819 (UMLS CUI [1])
C4035698 (UMLS CUI [2,1])
C2732831 (UMLS CUI [2,2])
C0678034 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C1334274 (UMLS CUI [5,1])
C0205322 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C0282564 (UMLS CUI [7])
C3541958 (UMLS CUI [8])
Complete Therapeutic procedure Operative Surgical Procedures Therapeutic radiology procedure | Neoadjuvant Therapy Chemotherapy | Chemotherapy, Adjuvant
Item
4. patients must have completed all their local and regional treatments including adequate surgery and radiation therapy, and at least 6 cycles of chemotherapy (neoadjuvant and/or adjuvant) according to institutional and national standards.
boolean
C0205197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
Time Interval | First line treatment | Complete Operative Surgical Procedures Chemotherapy Regimen Therapeutic radiology procedure
Item
5. the time interval between the end of all the first line standard treatment (completion of surgery, chemotherapy and radiation therapy) should be at least 3 months and within a maximum of 18 months before inclusion in the study.
boolean
C0872291 (UMLS CUI [1])
C1708063 (UMLS CUI [2])
C0205197 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C1522449 (UMLS CUI [3,4])
Breast Carcinoma Recurrence | Breast Carcinoma Neoplasm Metastasis
Item
1. any breast cancer recurrence or metastasis.
boolean
C0678222 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
HER2-positive carcinoma of breast | Immunohistochemistry Score | Fluorescent in Situ Hybridization | Chromogenic in situ Hybridization
Item
2. patients with her2/neu positive breast carcinoma (ihc score 2+ or 3+ and/or fish/cish-amplified).
boolean
C1960398 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162789 (UMLS CUI [3])
C1516514 (UMLS CUI [4])
Bleeding uncontrolled | Blood Coagulation Disorders | Thrombocytopenia | Thrombosis
Item
3. patients with any uncontrolled bleeding disorder including coagulation disorder or thrombocytopenia or prothrombotic disorder.
boolean
C3842135 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0040053 (UMLS CUI [4])
Autoimmune Diseases | Multiple Sclerosis | Lupus Erythematosus | rheumatoid; polyarthritis | Inflammatory Bowel Diseases | Graves Disease | Hashimoto Disease
Item
4. patients with a personal history of autoimmune disease (including but not limited to multiple sclerosis, lupus, rheumatoid polyarthritis, inflammatory bowel diseases, graves' disease and hashimoto's disease).
boolean
C0004364 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C1405320 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0018213 (UMLS CUI [6])
C0677607 (UMLS CUI [7])
anaphylaxis Vaccines | Hypersensitivity Vaccines | anaphylaxis Allergens | Hypersensitivity Allergens
Item
5. patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or other known or unknown allergens.
boolean
C0002792 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0002792 (UMLS CUI [3,1])
C0002092 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0002092 (UMLS CUI [4,2])
Vaccines commercial | Vaccines Clinical Research | Vaccines
Item
6. patients who have received any commercial vaccine within one month before the first dose of study vaccine or are planned to receive any vaccine till 3 weeks after the 6th vaccine injection.
boolean
C0042210 (UMLS CUI [1,1])
C0680536 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3])