ID

14772

Description

Molecular Triaging and Diagnostic Imaging to Guide Neoadjuvant Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02276443

Link

https://clinicaltrials.gov/show/NCT02276443

Keywords

Versions (1)
  1. 4/27/16 4/27/16 -
Uploaded on

April 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02276443

English

Eligibility Breast Cancer NCT02276443

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage i to iii
Description

Invasive breast carcinoma | Primary tumor site Biopsy | Primary tumor site Surgery specialty

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0475447
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C0475447
UMLS CUI [3,2]
C0038894
2. the clinical or radiologic primary tumor size is at least 1.5 cm diameter
Description

Primary tumor size

Data type

boolean

Alias
UMLS CUI [1]
C1302656
3. the patient was proven to have tnbc, defined from standard pathologic assays as negative for er and pr (<10% tumor staining) and negative for her2 (ihc score <3, gene copy number not amplified).
Description

Triple-Negative Breast Cancer Finding | Immunohistochemistry Score | Gene Dosage

Data type

boolean

Alias
UMLS CUI [1]
C2348819
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0449820
UMLS CUI [3]
C0178655
4. primary tumor sample was collected before nact began and was evaluated for genomic testing (integral biomarker). this allows patients who participate in 2011-0007 to be eligible for study participation.
Description

Tumor tissue sample | Neoadjuvant Therapy | Genomic Biomarker

Data type

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2]
C0600558
UMLS CUI [3]
C2348747
5. patients must be >18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. patients must have lvef > 50% by muga or echo within 4 weeks prior to registration.
Description

Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiogram

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
UMLS CUI [3]
C2243117
7. 3.1.7 patients must have adequate organ and marrow function as defined below: •
Description

body system or organ function | Bone Marrow Function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0542341
leukocytes >3,000/mcl • absolute neutrophil count >1,500/mcl • platelets >100,000/mcl
Description

White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
• total bilirubin within normal institutional limits • ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal • creatinine within normal institutional limits or • creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
Description

Bilirubin, total measurement | SGOT - Glutamate oxaloacetate transaminase | SGPT - Glutamate pyruvate transaminase | Upper Limit of Normal | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0242192
UMLS CUI [3]
C0376147
UMLS CUI [4]
C1519815
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the patient has diagnosis of stage iv disease or is found to have stage iv disease prior to randomization.
Description

Disease Stage level 4

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0441772
2. prior history of invasive cancer within 5 years of study entry or history of metastatic cancer. exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin.
Description

invasive cancer | Neoplasm Metastasis | Basal cell carcinoma | Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0553723
3. prior excisional biopsy of the primary invasive breast cancer.
Description

Excision biopsy Invasive breast carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0184921
UMLS CUI [1,2]
C0853879
4. patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging.
Description

Hematoma | Biopsy site Changing | primary tumor Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0018944
UMLS CUI [2,1]
C1301128
UMLS CUI [2,2]
C0392747
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0011923
5. patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens.
Description

Chemotherapy Regimen taxane | Chemotherapy Regimen Anthracycline Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0215136
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0003234
6. prior therapy with anthracyclines.
Description

Prior Therapy Anthracycline Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003234
7. grade ii or higher neuropathy.
Description

Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
8. patients with zubrod performance status of >2.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
9. patients with history of serious cardiac events defined as: • patients with a history of new york heart association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cva within 6 months of protocol registration. •
Description

cardiac event | Heart failure | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0741923
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0038454
patients who have history of pr prolongation (grade 2 or higher) or av block.
Description

Prolonged PR interval | Atrioventricular Block

Data type

boolean

Alias
UMLS CUI [1]
C0600125
UMLS CUI [2]
C0004245
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Similar models

Eligibility Breast Cancer NCT02276443

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive breast carcinoma | Primary tumor site Biopsy | Primary tumor site Surgery specialty
Item
1. the patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage i to iii
boolean
C0853879 (UMLS CUI [1])
C0475447 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0475447 (UMLS CUI [3,1])
C0038894 (UMLS CUI [3,2])
Primary tumor size
Item
2. the clinical or radiologic primary tumor size is at least 1.5 cm diameter
boolean
C1302656 (UMLS CUI [1])
Triple-Negative Breast Cancer Finding | Immunohistochemistry Score | Gene Dosage
Item
3. the patient was proven to have tnbc, defined from standard pathologic assays as negative for er and pr (<10% tumor staining) and negative for her2 (ihc score <3, gene copy number not amplified).
boolean
C2348819 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0178655 (UMLS CUI [3])
Tumor tissue sample | Neoadjuvant Therapy | Genomic Biomarker
Item
4. primary tumor sample was collected before nact began and was evaluated for genomic testing (integral biomarker). this allows patients who participate in 2011-0007 to be eligible for study participation.
boolean
C0475358 (UMLS CUI [1])
C0600558 (UMLS CUI [2])
C2348747 (UMLS CUI [3])
Age
Item
5. patients must be >18 years of age
boolean
C0001779 (UMLS CUI [1])
Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiogram
Item
6. patients must have lvef > 50% by muga or echo within 4 weeks prior to registration.
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C2243117 (UMLS CUI [3])
body system or organ function | Bone Marrow Function
Item
7. 3.1.7 patients must have adequate organ and marrow function as defined below: •
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement
Item
leukocytes >3,000/mcl • absolute neutrophil count >1,500/mcl • platelets >100,000/mcl
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Bilirubin, total measurement | SGOT - Glutamate oxaloacetate transaminase | SGPT - Glutamate pyruvate transaminase | Upper Limit of Normal | Creatinine measurement, serum | Creatinine clearance measurement
Item
• total bilirubin within normal institutional limits • ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal • creatinine within normal institutional limits or • creatinine clearance >60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
boolean
C0201913 (UMLS CUI [1])
C0242192 (UMLS CUI [2])
C0376147 (UMLS CUI [3])
C1519815 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Disease Stage level 4
Item
1. the patient has diagnosis of stage iv disease or is found to have stage iv disease prior to randomization.
boolean
C0012634 (UMLS CUI [1,1])
C0441772 (UMLS CUI [1,2])
invasive cancer | Neoplasm Metastasis | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
2. prior history of invasive cancer within 5 years of study entry or history of metastatic cancer. exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin.
boolean
C0677898 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0553723 (UMLS CUI [4])
Excision biopsy Invasive breast carcinoma
Item
3. prior excisional biopsy of the primary invasive breast cancer.
boolean
C0184921 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
Hematoma | Biopsy site Changing | primary tumor Diagnostic Imaging
Item
4. patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging.
boolean
C0018944 (UMLS CUI [1])
C1301128 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
Chemotherapy Regimen taxane | Chemotherapy Regimen Anthracycline Antibiotics
Item
5. patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0003234 (UMLS CUI [2,2])
Prior Therapy Anthracycline Antibiotics
Item
6. prior therapy with anthracyclines.
boolean
C1514463 (UMLS CUI [1,1])
C0003234 (UMLS CUI [1,2])
Neuropathy
Item
7. grade ii or higher neuropathy.
boolean
C0442874 (UMLS CUI [1])
Zubrod Performance Status
Item
8. patients with zubrod performance status of >2.
boolean
C3714786 (UMLS CUI [1])
cardiac event | Heart failure | Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
9. patients with history of serious cardiac events defined as: • patients with a history of new york heart association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cva within 6 months of protocol registration. •
boolean
C0741923 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Prolonged PR interval | Atrioventricular Block
Item
patients who have history of pr prolongation (grade 2 or higher) or av block.
boolean
C0600125 (UMLS CUI [1])
C0004245 (UMLS CUI [2])
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