Triple Negative Breast Neoplasm Invasive TNM Breast tumor staging | Indication Systemic Chemotherapy
Item
1. newly diagnosed histologically confirmed stage i-iii, er, pr and her2 negative invasive breast cancer as defined by the asco cap guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard nccn practice guidelines.
boolean
C3539878 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C1883256 (UMLS CUI [2,2])
Informed Consent
Item
2. willing and able to provide written informed consent for voluntary participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Neoplasm Core needle biopsy | Blood draw | Correlative Study
Item
3. willing to undergo a baseline tumor core needle biopsy and blood draws for correlative science studies.
boolean
C0027651 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2])
C1511524 (UMLS CUI [3])
Age
Item
4. eighteen years of age or older on the day of signing informed consent.
boolean
C0001779 (UMLS CUI [1])
Female infertility | Urine pregnancy test negative | Serum pregnancy test negative
Item
5. female subjects must either be of non-reproductive potential or must have a negative urine or serum pregnancy test upon study entry.
boolean
C0021361 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
Organ function | Chemotherapy Receive
Item
6. patients should have adequate organ function to tolerate chemotherapy, as defined by:
boolean
C0678852 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Granulocyte count Peripheral blood
Item
peripheral granulocyte count of > 1,500/mm3
boolean
C0857490 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelet count > 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin >9 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) each < 1.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine < 1.5 x uln or serum creatinine clearance < 50ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
International Normalized Ratio | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
inr/pt/ptt each < 1.5 x uln
boolean
C0525032 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
Thyroid stimulating hormone normal
Item
tsh within normal limits
boolean
C0858305 (UMLS CUI [1])
Excision biopsy Partial | Segmental Mastectomy | Modified radical mastectomy | Sentinel Lymph Node Biopsy
Item
1. patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node.
boolean
C0184921 (UMLS CUI [1,1])
C0728938 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0024883 (UMLS CUI [3])
C0796693 (UMLS CUI [4])
Medical contraindication Anthracyclines | Medical contraindication Paclitaxel | Medical contraindication Antibody therapy
Item
2. patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated.
boolean
C1301624 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0281176 (UMLS CUI [3,2])
Autoimmune Disease | Patients Eligible | Hypothyroidism Stable | Serum TSH level normal | Hormone replacement therapy | Vitiligo | Psoriasis | Lacking Requirement Therapeutic procedure
Item
3. patients with active autoimmune disease or documented autoimmune disease within 2 years. patients with hypothyroidism that is clinically stable and have normal tsh levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study.
boolean
C0004364 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0020676 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0580433 (UMLS CUI [4])
C0282402 (UMLS CUI [5])
C0042900 (UMLS CUI [6])
C0033860 (UMLS CUI [7])
C0332268 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis
Item
4. active or prior documented inflammatory bowel disease (crohn's disease, ulcerative colitis).
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis
Item
5. patients with known active hepatitis b or c or hiv infection or with history of tuberculosis.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0041296 (UMLS CUI [4])