Breast Carcinoma | Lymphatic Invasion Dermal
Item
1. histological confirmation of breast carcinoma. pathologic evidence of dermal lymphatic invasion should be noted but not required.
boolean
C0678222 (UMLS CUI [1])
C1708790 (UMLS CUI [2,1])
C0221928 (UMLS CUI [2,2])
Inflammatory Breast Carcinoma | Breast changes inflammatory | Erythema diffuse | Heat | Ridging | Peau d'orange
Item
2. clinical diagnosis of ibc (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
boolean
C0278601 (UMLS CUI [1])
C0558236 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
C0858689 (UMLS CUI [3])
C0018837 (UMLS CUI [4])
C0332243 (UMLS CUI [5])
C0425791 (UMLS CUI [6])
Age
Item
3. >/= age 18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status </= 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
5. adequate hematologic function: absolute neutrophil count (anc) >/= 1.5 x 109/l, platelet count >/= 100 x 109/l, hemoglobin >/= 9.0 g/dl
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Cardiac function | Left ventricular ejection fraction
Item
6. adequate cardiac function (lvef >/= 45%)
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
7. adequate renal function: creatinine (cr) </= 1.5 mg/dl x uln, creatinine clearance (crcl) >/= 50 ml/min calculated by the cockcroft-gault method as follows: male creatinine clearance = (140 - age) x (weight in kg) / (serum cr x 72) female crcl = (140 - age) x (weight in kg) x 0.85 / (serum cr x 72)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
Item
8. adequate hepatic function: aspartate aminotransferase (ast) </= 2.5 x uln • alanine aminotransferase (alt) </= 2.5 x uln • alkaline phosphatase (alp) </= 2.5 x uln.total bilirubin </=1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Informed Consent
Item
9. ability and willingness to sign an informed consent form for this protocol
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Partner Male sterilization | Intrauterine Devices | Oral contraception | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condom | Vaginal Spermicide
Item
10. if female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (iud) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C0024559 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0029151 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
Neoplasm Metastasis | Local Therapy Site metastatic | Therapeutic radiology procedure | Operative Surgical Procedure | Patients Appropriate Operation on breast
Item
11. patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible,
boolean
C0027627 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C3714726 (UMLS CUI [5,3])
Therapeutic radiology procedure | Chemotherapy
Item
1. history of radiation or chemotherapy
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
HER2-positive carcinoma of breast Immunohistochemistry Staining Method | HER2 gene amplification FISH
Item
2. her2-positive breast carcinoma (ihc staining more than 3+ or her2 gene amplification by fish)
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Breast cancer recurrent
Item
3. recurrent breast cancer
boolean
C0278493 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured | Exception Disease Free Duration
Item
4. history of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
HIV Seropositivity | Hepatitis C positive | Hepatitis B positive | Hepatitis B, Chronic
Item
5. known positive test(s) for human immunodeficiency virus infection, hepatitis c virus, acute or chronic active hepatitis b infection
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0856706 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
Interstitial Lung Disease Extensive | Pneumonitis | Pulmonary Fibrosis | Interstitial Lung Disease Extensive Chest CT scan
Item
6. history of extensive interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest ct scan
boolean
C0206062 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C3714636 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0206062 (UMLS CUI [4,1])
C0205231 (UMLS CUI [4,2])
C0202823 (UMLS CUI [4,3])
Medical condition Difficulty with Assessment Toxicity | Mental condition Difficulty with Assessment Toxicity | Medical condition Difficulty with Assessment Effectiveness | Mental condition Difficulty with Assessment Effectiveness
Item
7. patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
boolean
C3843040 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0332218 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C1280519 (UMLS CUI [3,4])
C3840291 (UMLS CUI [4,1])
C0332218 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C1280519 (UMLS CUI [4,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Peripheral Neuropathy CTCAE Grades
Item
9. peripheral neuropathy >= gr ii
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])