Invasive carcinoma of breast Core needle biopsy | Invasive carcinoma of breast Incisional biopsy | Neoplasms TNM Breast tumor staging
Item
1. histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). tumors must be clinical stage t2-3 n0-2 or t1 n1-2 per ajcc staging edition 7 or clinical stage t2-3 n0-2 or t1 n1-2 by physical exam or radiologic studies.
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
BRCA gene Germ-Line Mutation Testing
Item
2. documented breast cancer gene (brca) germline mutation testing.
boolean
C0596223 (UMLS CUI [1,1])
C0206530 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Triple Negative Breast Neoplasms
Item
3. estrogen receptor (er)-, progesterone receptor (pr)-, and human epidermal growth factor receptor (her)2-negative (triple-negative) cancer of the breast.
boolean
C3539878 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Gender | Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Serum pregnancy test negative
Item
5. women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the investigator or they must have a negative serum pregnancy test prior to randomization.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
Cancer treatment Therapeutic intent Breast Carcinoma | Cytotoxic Chemotherapy | Immunotherapy | Biological treatment | Therapeutic radiology procedure | Investigational New Drugs
Item
1. previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
boolean
C0920425 (UMLS CUI [1,1])
C0302350 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0677881 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Carboplatin | Paclitaxel | Doxorubicin | Cyclophosphamide | Poly(ADP-ribose) Polymerase Inhibitors
Item
2. previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a poly-(adp-ribose)-polymerase (parp) inhibitor.
boolean
C0079083 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
C0013089 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
C1882413 (UMLS CUI [5])
Hormone replacement therapy ovarian | Pharmaceutical Preparations Hormonal To be stopped | Raloxifene | Tamoxifen | Selective Estrogen Receptor Modulators
Item
3. concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (serm). subjects must have discontinued use of such agents prior to beginning study treatment.
boolean
C0282402 (UMLS CUI [1,1])
C0205065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C1272691 (UMLS CUI [2,3])
C0244404 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0732611 (UMLS CUI [5])
Seizure
Item
4. a history of seizure within 12 months prior to study entry.
boolean
C0036572 (UMLS CUI [1])
Neuropathy Pre-existing CTCAE Grades
Item
5. pre-existing neuropathy from any cause in excess of grade 1.
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])