ID

44124

Description

Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02018458

Link

https://clinicaltrials.gov/show/NCT02018458

Keywords

Versions (2)
  1. 2/4/19 2/4/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02018458

English

Eligibility Breast Cancer NCT02018458

1 forms  
Criteria
Description

Criteria

a patient will be considered for enrollment in this study if all of the following criteria are met:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. female patients ≥18 years of age.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. have either:
Description

Criteria Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205369
1. locally advanced tnbc defined as invasive ductal cancer; er- tumors with <10% of tumor nuclei immunoreactive; pr- tumors with <10% of tumor nuclei immunoreactive; t3 or t4 disease, regardless of nodal status (t2 disease is eligible if there are positive lymph nodes present by physical exam or imaging evaluation or histological evaluation, or
Description

Triple Negative Breast Neoplasms Advanced Locally | Invasive Ductal Breast Carcinoma | Neoplasms Estrogen receptor negative | Neoplastic Cell Nuclei Immunoreaction Percentage | Neoplasms Progesterone receptor negative | Disease TNM Breast tumor staging Independent of Lymph nodal status

Data type

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C1134719
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0279756
UMLS CUI [4,1]
C0597032
UMLS CUI [4,2]
C0007610
UMLS CUI [4,3]
C0872193
UMLS CUI [4,4]
C0439165
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0279766
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0474926
UMLS CUI [6,3]
C0332291
UMLS CUI [6,4]
C0449927
2. high-risk er+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with ki67 ≥20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.
Description

High risk of Breast Carcinoma Estrogen receptor positive | Invasive Ductal Breast Carcinoma TNM Breast tumor staging | Mixed ductal and lobular carcinoma in situ of breast TNM Breast tumor staging | Breast Carcinoma TNM Breast tumor staging | Ki67 Measurement | Lymph node positive Physical Examination | Lymph node positive Imaging | Lymph node positive Histology Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0279754
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0474926
UMLS CUI [3,1]
C3666014
UMLS CUI [3,2]
C0474926
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0474926
UMLS CUI [5]
C4049944
UMLS CUI [6,1]
C0746319
UMLS CUI [6,2]
C0031809
UMLS CUI [7,1]
C0746319
UMLS CUI [7,2]
C0011923
UMLS CUI [8,1]
C0746319
UMLS CUI [8,2]
C0344441
3. her2- negative breast cancer. if her2-, it is defined as follows:
Description

Breast Carcinoma HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2348908
1. fish-negative (fish ratio <2.0), or
Description

FISH Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1513916
2. ihc 0-1+, or
Description

Immunohistochemistry Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1274040
3. ihc 2+ and fish-negative (fish ratio<2.0)
Description

Immunohistochemistry Result | FISH Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C1274040
UMLS CUI [2,1]
C0162789
UMLS CUI [2,2]
C1513916
4. eastern cooperative oncology group (ecog) performance status of 0-1 5. adequate hematologic function, defined by:
Description

ECOG performance status | Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0221130
1. absolute neutrophil count (anc) >1500/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count ≥100,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
3. hemoglobin >9 g/dl (in the absence of red blood cell transfusion) 6. adequate liver function, defined by:
Description

Hemoglobin measurement | Red Blood Cell Transfusion Absent | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0086252
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0232741
a. ast and alt ≤2.5 x the upper limit of normal (uln) b. total bilirubin ≤1.5 x uln 7. adequate renal function, defined by:
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0232804
a. serum creatinine ≤1.5 x uln or calculated creatinine clearance of ≥60 ml/min 8. patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease. 9. eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine. 10.patient must be accessible for treatment and follow-up. 11.patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment. 12.all patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Invasive cancer | Invasive carcinoma of breast | Prior Therapy Completed | Recurrent disease Absent | Paclitaxel | Doxorubicin | Cyclophosphamide | Carboplatin | Patients Available Therapeutic procedure | Patients Available Clinical Study Follow-up | Biopsy Tumor tissue sample | Exome sequence analysis | Tumor Microenvironment Evaluation | Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0677898
UMLS CUI [4]
C0853879
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C0205197
UMLS CUI [6,1]
C0277556
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0144576
UMLS CUI [8]
C0013089
UMLS CUI [9]
C0010583
UMLS CUI [10]
C0079083
UMLS CUI [11,1]
C0030705
UMLS CUI [11,2]
C0470187
UMLS CUI [11,3]
C0087111
UMLS CUI [12,1]
C0030705
UMLS CUI [12,2]
C0470187
UMLS CUI [12,3]
C3274571
UMLS CUI [13,1]
C0005558
UMLS CUI [13,2]
C0475358
UMLS CUI [14]
C3854133
UMLS CUI [15,1]
C2936626
UMLS CUI [15,2]
C1261322
UMLS CUI [16,1]
C0162340
UMLS CUI [16,2]
C2348563
UMLS CUI [17]
C0021430
exclusion criteria:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
a patient will be ineligible for inclusion in this study any of the following criteria are met:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. evidence of metastatic disease on bone scan and ct scan of chest/abdomen (or pet ct scan). patients with intrathoracic metastatic adenopathy are eligible.
Description

Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT of chest and abdomen | Neoplasm Metastasis PET/CT scan Chest and abdomen | Adenopathy metastatic thoracic Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1630402
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1699633
UMLS CUI [3,3]
C1442171
UMLS CUI [4,1]
C0497156
UMLS CUI [4,2]
C1522484
UMLS CUI [4,3]
C0817096
UMLS CUI [4,4]
C1548635
2. active infection or unexplained fever >38.5°c during screening.
Description

Communicable Disease | Unexplained fever

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C1844662
3. active infections including viral hepatitis and hiv.
Description

Communicable Diseases | Viral hepatitis | HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0019693
4. active asthma or other condition requiring steroid therapy.
Description

Asthma | Condition Requiring Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0149783
5. autoimmune disease including lupus erythematosus or rheumatoid arthritis. topical or inhaled corticosteroids are allowed.
Description

Autoimmune Disease | Lupus Erythematosus | Rheumatoid Arthritis | Topical corticosteroids allowed | Inhaled steroids allowed

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0003873
UMLS CUI [4,1]
C0304604
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C2065041
UMLS CUI [5,2]
C0683607
6. patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).the use of an lhrh agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.
Description

Systemic therapy Breast Carcinoma | Chemotherapy | Antibody therapy | Targeted Therapy | LHRH Agonist allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0281176
UMLS CUI [4]
C2985566
UMLS CUI [5,1]
C1518041
UMLS CUI [5,2]
C0683607
7. women who are pregnant or lactating. all patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
Description

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
8. have a nyha class iii or iv chf or lvef <55%. patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.
Description

Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction | Heart Diseases | Ventricular arrhythmia Requiring Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0018799
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0013227
9. patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
Description

Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status | Condition Affecting Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2348568
1. severe impaired lung functions as defined as spirometry and dlco that is 50% of the normal predicted value and/or o2 saturation that is 88% or less at rest on room air
Description

Pulmonary function impairment Severe Spirometry | Pulmonary function impairment Severe DLCO | Pulmonary function impairment Severe | Oxygen saturation measurement Resting on room air

Data type

boolean

Alias
UMLS CUI [1,1]
C0858943
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0037981
UMLS CUI [2,1]
C0858943
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1516251
UMLS CUI [3,1]
C0858943
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0523807
UMLS CUI [4,2]
C0035253
UMLS CUI [4,3]
C2709070
2. uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln
Description

Diabetic - poor control | Serum fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0583334
3. liver disease such as cirrhosis or severe hepatic impairment (child-pugh class c).
Description

Liver disease | Liver Cirrhosis | Hepatic impairment Severe Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C4050412
10. history of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.
Description

Comorbidity Suspicious | Physical Examination Suspicious | Laboratory test finding Suspicious | Medical contraindication Investigational New Drugs | Disease Affecting Interpretation Research results | Condition Affecting Interpretation Research results | Disease High risk Complications of treatment | Condition High risk Complications of treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750493
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0750493
UMLS CUI [3,1]
C0587081
UMLS CUI [3,2]
C0750493
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0013230
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0332167
UMLS CUI [7,3]
C0679861
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0332167
UMLS CUI [8,3]
C0679861
11. any other investigational or anti-cancer treatments while participating in this study.
Description

Therapy, Investigational | Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C0920425
12. any other cancer
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
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Similar models

Eligibility Breast Cancer NCT02018458

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Criteria Fulfill
Item
a patient will be considered for enrollment in this study if all of the following criteria are met:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Gender | Age
Item
1. female patients ≥18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Criteria Specified
Item
2. have either:
boolean
C0243161 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Triple Negative Breast Neoplasms Advanced Locally | Invasive Ductal Breast Carcinoma | Neoplasms Estrogen receptor negative | Neoplastic Cell Nuclei Immunoreaction Percentage | Neoplasms Progesterone receptor negative | Disease TNM Breast tumor staging Independent of Lymph nodal status
Item
1. locally advanced tnbc defined as invasive ductal cancer; er- tumors with <10% of tumor nuclei immunoreactive; pr- tumors with <10% of tumor nuclei immunoreactive; t3 or t4 disease, regardless of nodal status (t2 disease is eligible if there are positive lymph nodes present by physical exam or imaging evaluation or histological evaluation, or
boolean
C3539878 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1134719 (UMLS CUI [2])
C0027651 (UMLS CUI [3,1])
C0279756 (UMLS CUI [3,2])
C0597032 (UMLS CUI [4,1])
C0007610 (UMLS CUI [4,2])
C0872193 (UMLS CUI [4,3])
C0439165 (UMLS CUI [4,4])
C0027651 (UMLS CUI [5,1])
C0279766 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0474926 (UMLS CUI [6,2])
C0332291 (UMLS CUI [6,3])
C0449927 (UMLS CUI [6,4])
High risk of Breast Carcinoma Estrogen receptor positive | Invasive Ductal Breast Carcinoma TNM Breast tumor staging | Mixed ductal and lobular carcinoma in situ of breast TNM Breast tumor staging | Breast Carcinoma TNM Breast tumor staging | Ki67 Measurement | Lymph node positive Physical Examination | Lymph node positive Imaging | Lymph node positive Histology Procedure
Item
2. high-risk er+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with ki67 ≥20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.
boolean
C0332167 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279754 (UMLS CUI [1,3])
C1134719 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C3666014 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C4049944 (UMLS CUI [5])
C0746319 (UMLS CUI [6,1])
C0031809 (UMLS CUI [6,2])
C0746319 (UMLS CUI [7,1])
C0011923 (UMLS CUI [7,2])
C0746319 (UMLS CUI [8,1])
C0344441 (UMLS CUI [8,2])
Breast Carcinoma HER2 Negative
Item
3. her2- negative breast cancer. if her2-, it is defined as follows:
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
FISH Negative
Item
1. fish-negative (fish ratio <2.0), or
boolean
C0162789 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Immunohistochemistry Result
Item
2. ihc 0-1+, or
boolean
C0021044 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Immunohistochemistry Result | FISH Negative
Item
3. ihc 2+ and fish-negative (fish ratio<2.0)
boolean
C0021044 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0162789 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
ECOG performance status | Hematologic function
Item
4. eastern cooperative oncology group (ecog) performance status of 0-1 5. adequate hematologic function, defined by:
boolean
C1520224 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) >1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Red Blood Cell Transfusion Absent | Liver function
Item
3. hemoglobin >9 g/dl (in the absence of red blood cell transfusion) 6. adequate liver function, defined by:
boolean
C0518015 (UMLS CUI [1])
C0086252 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Renal function
Item
a. ast and alt ≤2.5 x the upper limit of normal (uln) b. total bilirubin ≤1.5 x uln 7. adequate renal function, defined by:
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Invasive cancer | Invasive carcinoma of breast | Prior Therapy Completed | Recurrent disease Absent | Paclitaxel | Doxorubicin | Cyclophosphamide | Carboplatin | Patients Available Therapeutic procedure | Patients Available Clinical Study Follow-up | Biopsy Tumor tissue sample | Exome sequence analysis | Tumor Microenvironment Evaluation | Comprehension Study Protocol | Informed Consent
Item
a. serum creatinine ≤1.5 x uln or calculated creatinine clearance of ≥60 ml/min 8. patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease. 9. eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine. 10.patient must be accessible for treatment and follow-up. 11.patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment. 12.all patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0677898 (UMLS CUI [3])
C0853879 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
C0277556 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0144576 (UMLS CUI [7])
C0013089 (UMLS CUI [8])
C0010583 (UMLS CUI [9])
C0079083 (UMLS CUI [10])
C0030705 (UMLS CUI [11,1])
C0470187 (UMLS CUI [11,2])
C0087111 (UMLS CUI [11,3])
C0030705 (UMLS CUI [12,1])
C0470187 (UMLS CUI [12,2])
C3274571 (UMLS CUI [12,3])
C0005558 (UMLS CUI [13,1])
C0475358 (UMLS CUI [13,2])
C3854133 (UMLS CUI [14])
C2936626 (UMLS CUI [15,1])
C1261322 (UMLS CUI [15,2])
C0162340 (UMLS CUI [16,1])
C2348563 (UMLS CUI [16,2])
C0021430 (UMLS CUI [17])
Exclusion Criteria
Item
exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
Criteria Fulfill
Item
a patient will be ineligible for inclusion in this study any of the following criteria are met:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT of chest and abdomen | Neoplasm Metastasis PET/CT scan Chest and abdomen | Adenopathy metastatic thoracic Eligible
Item
1. evidence of metastatic disease on bone scan and ct scan of chest/abdomen (or pet ct scan). patients with intrathoracic metastatic adenopathy are eligible.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C1630402 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C1699633 (UMLS CUI [3,2])
C1442171 (UMLS CUI [3,3])
C0497156 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
C0817096 (UMLS CUI [4,3])
C1548635 (UMLS CUI [4,4])
Communicable Disease | Unexplained fever
Item
2. active infection or unexplained fever >38.5°c during screening.
boolean
C0009450 (UMLS CUI [1])
C1844662 (UMLS CUI [2])
Communicable Diseases | Viral hepatitis | HIV Infections
Item
3. active infections including viral hepatitis and hiv.
boolean
C0009450 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Asthma | Condition Requiring Steroid therapy
Item
4. active asthma or other condition requiring steroid therapy.
boolean
C0004096 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0149783 (UMLS CUI [2,3])
Autoimmune Disease | Lupus Erythematosus | Rheumatoid Arthritis | Topical corticosteroids allowed | Inhaled steroids allowed
Item
5. autoimmune disease including lupus erythematosus or rheumatoid arthritis. topical or inhaled corticosteroids are allowed.
boolean
C0004364 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0304604 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C2065041 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Systemic therapy Breast Carcinoma | Chemotherapy | Antibody therapy | Targeted Therapy | LHRH Agonist allowed
Item
6. patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).the use of an lhrh agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0281176 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
C1518041 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods
Item
7. women who are pregnant or lactating. all patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction | Heart Diseases | Ventricular arrhythmia Requiring Pharmaceutical Preparations
Item
8. have a nyha class iii or iv chf or lvef <55%. patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status | Condition Affecting Study Subject Participation Status
Item
9. patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Pulmonary function impairment Severe Spirometry | Pulmonary function impairment Severe DLCO | Pulmonary function impairment Severe | Oxygen saturation measurement Resting on room air
Item
1. severe impaired lung functions as defined as spirometry and dlco that is 50% of the normal predicted value and/or o2 saturation that is 88% or less at rest on room air
boolean
C0858943 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
C0858943 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1516251 (UMLS CUI [2,3])
C0858943 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0523807 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C2709070 (UMLS CUI [4,3])
Diabetic - poor control | Serum fasting glucose measurement
Item
2. uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln
boolean
C0421258 (UMLS CUI [1])
C0583334 (UMLS CUI [2])
Liver disease | Liver Cirrhosis | Hepatic impairment Severe Child-Pugh Classification
Item
3. liver disease such as cirrhosis or severe hepatic impairment (child-pugh class c).
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0948807 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C4050412 (UMLS CUI [3,3])
Comorbidity Suspicious | Physical Examination Suspicious | Laboratory test finding Suspicious | Medical contraindication Investigational New Drugs | Disease Affecting Interpretation Research results | Condition Affecting Interpretation Research results | Disease High risk Complications of treatment | Condition High risk Complications of treatment
Item
10. history of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.
boolean
C0009488 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0587081 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C0348080 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0012634 (UMLS CUI [7,1])
C0332167 (UMLS CUI [7,2])
C0679861 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0332167 (UMLS CUI [8,2])
C0679861 (UMLS CUI [8,3])
Therapy, Investigational | Cancer treatment
Item
11. any other investigational or anti-cancer treatments while participating in this study.
boolean
C0949266 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Cancer Other
Item
12. any other cancer
boolean
C1707251 (UMLS CUI [1])
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