Gender | Locally advanced breast cancer | Age
Item
1. female patients,locally advanced breast cancer,age ≥18 years.
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Breast adenocarcinoma Invasive
Item
2. histologically confirmed invasive adenocarcinoma of the breast.
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Palpable disease Primary Breast Physical Examination | Palpable disease Primary Axilla Physical Examination | Axillary lymphadenopathy Absent | Primary tumor Diameter Physical Examination TNM Breast tumor staging | Primary tumor Diameter Imaging studies TNM Breast tumor staging | Axillary lymphadenopathy Suspicious | Primary tumor Size TNM Breast tumor staging
Item
3. primary palpable disease confined to a breast and axilla on physical examination. for patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical t2-t3, n0-n1, m0). for patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical t1-3, n1-2, m0). (t1n0m0 lesions are excluded.)
boolean
C0522499 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C0522499 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
C0031809 (UMLS CUI [2,4])
C0578735 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
C0474926 (UMLS CUI [4,4])
C0677930 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C1881134 (UMLS CUI [5,3])
C0474926 (UMLS CUI [5,4])
C0578735 (UMLS CUI [6,1])
C0750493 (UMLS CUI [6,2])
C0677930 (UMLS CUI [7,1])
C0456389 (UMLS CUI [7,2])
C0474926 (UMLS CUI [7,3])
Palpable breast mass Absent | Axillary lymph nodes Palpable Absent | Tumor Mass Measurable Radiography | Mammography | MRI | Ultrasonography, Mammary
Item
4. patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are acceptable. accepted procedures for measuring breast disease are mammography, mri, and breast ultrasound. this will need to be re-evaluated after 3 cycles and prior to surgery.
boolean
C1403543 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0729594 (UMLS CUI [2,1])
C0522499 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3273930 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0024671 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0080264 (UMLS CUI [6])
ECOG performance status
Item
5. ecog 0 or 2
boolean
C1520224 (UMLS CUI [1])
Distant metastasis Absent TNM Breast tumor staging
Item
6. no distant metastasis, as documented by complete staging workup ≤6 weeks prior to initiation of study treatment.
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Prior Therapy Absent Breast Carcinoma
Item
7. no previous treatment for breast cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Hematologic function
Item
8. adequate hematologic function with:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
absolute neutrophil count (anc) >1500/μl. platelets ≥100,000/μl. hemoglobin ≥10 g/dl.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Liver function
Item
9. adequate hepatic function with:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum bilirubin ≤ the institutional upper limit of normal (uln). aspartate aminotransferase (ast) ≤2.5 x institutional uln. alanine aminotransferase (alt) ≤2.5 x institutional uln.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
10. adequate renal function with serum creatinine ≤1.5 x uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Systemic Chemotherapy Neoadjuvant Primary | Excision Primary tumor Residual | Mastectomy | Lumpectomy | Breast-Conserving Surgery | Chemotherapy Neoadjuvant Completed
Item
11. planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy
boolean
C1883256 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0728940 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1609982 (UMLS CUI [2,3])
C0024881 (UMLS CUI [3])
C0024885 (UMLS CUI [4])
C0917927 (UMLS CUI [5])
C0392920 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0205197 (UMLS CUI [6,3])
Inflammatory Breast Carcinoma
Item
1. inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
2. pregnancy or breast-feeding.a negative serum pregnancy test within 7 days prior to first study treatment (day 1, cycle 1) for all women of childbearing potential is required. patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for 3 weeks after their last dose of study treatment. patients must agree to not breast-feed while receiving study treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Hormone replacement therapy ovarian | Hormone preparation To be stopped | Raloxifene To be stopped | Tamoxifen To be stopped | Selective Estrogen Receptor Modulators To be stopped
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). patients must have discontinued use of such agents prior to beginning study treatment.
boolean
C0282402 (UMLS CUI [1,1])
C0205065 (UMLS CUI [1,2])
C0019932 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0244404 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C0732611 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Comorbidity Uncontrolled | Communicable Disease
Item
4. uncontrolled intercurrent illness including (but not limited to) ongoing or active infection.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
Cancer treatment | Exception Investigational New Drugs Clinical Trial Current
Item
5. concurrent treatment with any anti-cancer therapy other than those agents used in this study.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0521116 (UMLS CUI [2,4])
Mental condition Preventing Comprehension Study Protocol | Mental disorders Preventing Comprehension Study Protocol | Mental condition Limiting Protocol Compliance | Mental disorders Limiting Protocol Compliance
Item
6. mental condition or psychiatric disorder that would prevent patient comprehension of the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.
boolean
C3840291 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])