Age
Item
age > 18 years old
boolean
C0001779 (UMLS CUI [1])
Triple Negative Breast Neoplasm Invasive
Item
histologically-confirmed triple negative invasive breast carcinoma
boolean
C3539878 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Invasive Ductal Breast Carcinoma Type Any | Invasive Lobular Breast Carcinoma Type Any
Item
any type of ductal or lobular invasive carcinoma
boolean
C1134719 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0279565 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
BRCA1 gene mutation | BRCA2 gene mutation | BRCA1 gene mutation Absent | BRCA2 gene mutation Absent
Item
patients with or without brca-1 and brca-2 mutations are eligible to participate
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
C1511022 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1511024 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Premenopausal state | Perimenopausal state | Postmenopausal state
Item
pre-, peri- or postmenopausal
boolean
C0232969 (UMLS CUI [1])
C3839366 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
TNM Breast tumor staging
Item
clinical stage t2-4, n0-3, m0 (stage ii-iii)
boolean
C0474926 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representatives
Item
patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Hematologic function | Renal function | Liver function | Functional Status allowing Chemotherapy
Item
adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. however, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0598463 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
Invasive carcinoma of breast Previous | Therapeutic procedure Invasive carcinoma of breast | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Aromatase Inhibitors | Tamoxifen | Raloxifene | fulvestrant | Estrogen Antagonists | Selective Estrogen Receptor Modulators
Item
prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including ais, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/serm)
boolean
C0853879 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0853879 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0593802 (UMLS CUI [6])
C0039286 (UMLS CUI [7])
C0244404 (UMLS CUI [8])
C0935916 (UMLS CUI [9])
C0014930 (UMLS CUI [10])
C0732611 (UMLS CUI [11])
Second Primary Cancers | Exception Skin carcinoma | Exception Treatment completed Malignant Neoplasm | Exception Low Risk Relapse
Item
patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0580352 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3538919 (UMLS CUI [4,2])
C0035020 (UMLS CUI [4,3])
Ductal carcinoma in situ only | Lobular carcinoma in situ only | Component In situ Absent
Item
only ductal/lobular carcinoma in situ but not invasive component
boolean
C0007124 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0334381 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1705248 (UMLS CUI [3,1])
C0444498 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Neoplasm Metastasis Type Any TNM clinical staging
Item
any sort of confirmed metastatic disease (ajcc stage iv at diagnosis)
boolean
C0027627 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Radiotherapy to breast Locally | Radiotherapy to axilla Locally | Status pre- Neoadjuvant Chemotherapy
Item
any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
boolean
C0948310 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C1997064 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C3665472 (UMLS CUI [3,3])
Pregnancy Excludes Chemotherapy | Breast Feeding Excludes Chemotherapy
Item
pregnant or lactating, in case this precludes the subject to receive chemotherapy.
boolean
C0032961 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Neoadjuvant Chemotherapy Receive Unsuccessful | Etiology Comorbidity Significant | Etiology Hypersensitivity | Etiology Performance status
Item
impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. this will be exclusively decided by the treating oncologists.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C1518965 (UMLS CUI [4,2])