Study Subject Participation Status | Criteria Fulfill
Item
the following criteria are necessary for study participation:
boolean
C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Locally advanced breast cancer | First line treatment Absent | Chemotherapy Neoadjuvant | Chemoradiotherapy Neoadjuvant
Item
1. histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
boolean
C3495949 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0436307 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
Measurable Disease Ultrasonography | Measurable Disease MRI
Item
2. measurable disease by ultrasound, or mri performed within 28 days prior to treatment
boolean
C1513041 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
ECOG performance status
Item
3. eastern co-operative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Hemoglobin measurement
Item
hemoglobin >90 mg/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leukocytes >3,000/ml
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >1,500/ml
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >100,000/ml
boolean
C0032181 (UMLS CUI [1])
Bilirubin total normal
Item
total bilirubin within normal institutional limits
boolean
C0860928 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised
Item
creatinine within normal institutional limits or creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
boolean
C0438244 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
Informed Consent
Item
6. patients should have the ability to understand and the willingness to sign a written informed consent document. signed informed consent must be obtained prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Gender | Exclusion Criteria
Item
the following conditions will exclude women from participation:
boolean
C0079399 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Major surgery | Adverse event Due to Pharmaceutical Preparations | Patient Recovery Lacking
Item
1. chemotherapy, radiotherapy, or major surgery within 4 prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Investigational New Drugs
Item
2. receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
3. known brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Chemical Structure Similar
Item
4. history of allergic reactions attributed to compounds of similar chemical or biologic composition
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0220807 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Medical contraindication Therapeutic radiology procedure
Item
5. contraindications to radiotherapy such as but not limited to:
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Prior radiation therapy Area Involved
Item
previous radiotherapy to an involved area
boolean
C0279134 (UMLS CUI [1,1])
C0005902 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Collagen-vascular disease
Item
active collagen vascular disease
boolean
C0262428 (UMLS CUI [1])
Hereditary Diseases Associated with Sensitivity to radiation
Item
genetic diseases associated with hyper-radiosensitivity
boolean
C0019247 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0520903 (UMLS CUI [1,3])
Communicable Diseases Serious | Requirement Anti-Bacterial Agents Systemic | Requirement Antifungal Agents Systemic | Requirement Antiviral Agents Systemic
Item
6. any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0279516 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0003308 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0003451 (UMLS CUI [4,2])
C0205373 (UMLS CUI [4,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia
Item
7. uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
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])
Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Epilepsy
Item
9. history of active ongoing seizure disorder
boolean
C0014544 (UMLS CUI [1])
Substance Use Disorders Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Study Subject Participation Status | Social Conditions Interfere with Evaluation Research results
Item
10. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0037403 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Patient's condition unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance
Item
11. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
boolean
C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])