ID

43677

Description

Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00256243

Link

https://clinicaltrials.gov/show/NCT00256243

Keywords

Versions (2)
  1. 9/30/16 9/30/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Inflammatory Breast Cancer NCT00256243

English

Eligibility Inflammatory Breast Cancer NCT00256243

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. histologic confirmation shall be by either core needle biopsy or incisional biopsy. punch biopsy is allowed if invasive breast cancer is documented.
Description

Locally advanced breast cancer | Inflammatory Breast Carcinoma | Core needle biopsy | Incisional biopsy | Invasive carcinoma of breast | Punch biopsy

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278601
UMLS CUI [3]
C1318309
UMLS CUI [4]
C0184922
UMLS CUI [5]
C0853879
UMLS CUI [6]
C0184924
patients must meet one of the criteria defined below (indicate one):
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. selected stage iib (t3, n0, m0) or iiia (t3, n1-2, m0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.
Description

TNM clinical staging | disease stage unresectable Primary | Indication Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0699749
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C0205225
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0600558
2. stage iiib (t4, any n, m0) or (any t, n3, m0) disease.
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
Description

Physical Examination | Plain chest X-ray | roentgenographic Neoplasm Assessment | Scanning Neoplasm Assessment

Data type

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0039985
UMLS CUI [3,1]
C0034571
UMLS CUI [3,2]
C0027651
UMLS CUI [3,3]
C1516048
UMLS CUI [4,1]
C0441633
UMLS CUI [4,2]
C0027651
UMLS CUI [4,3]
C1516048
patients with the clinical diagnosis of congestive heart failure or angina pectoris are not eligible. patients with hypertension or age > 60 years must have a multiple gated acquisition (muga) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (na) if no muga required) and left ventricular ejection fraction (lvef) % must be greater than the institutional lower limit of normal.
Description

Congestive heart failure | Angina Pectoris | Hypertensive disease | Age | Multiple gated acquisition scanning | Echocardiography | Multiple gated acquisition scanning Not Applicable | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0521317
UMLS CUI [6]
C0013516
UMLS CUI [7,1]
C0521317
UMLS CUI [7,2]
C1272460
UMLS CUI [8]
C0428772
patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) ≤ 2x the institutional upper limit of normal. these tests must have been performed within 90 days prior to registration.
Description

Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
patients must have an absolute neutrophil count (anc) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. these tests must have been performed within 90 days prior to registration.
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
patients must have a performance status of 0-2 by zubrod criteria
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. a urine pregnancy test is required for women of childbearing potential.
Description

Pregnancy | Breast Feeding | Fertility Female Contraceptive methods | Childbearing Potential Urine pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0086287
UMLS CUI [3,3]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430056
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Back to the top of the page

Similar models

Eligibility Inflammatory Breast Cancer NCT00256243

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Inflammatory Breast Carcinoma | Core needle biopsy | Incisional biopsy | Invasive carcinoma of breast | Punch biopsy
Item
patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. histologic confirmation shall be by either core needle biopsy or incisional biopsy. punch biopsy is allowed if invasive breast cancer is documented.
boolean
C3495949 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C1318309 (UMLS CUI [3])
C0184922 (UMLS CUI [4])
C0853879 (UMLS CUI [5])
C0184924 (UMLS CUI [6])
criteria Fulfill
Item
patients must meet one of the criteria defined below (indicate one):
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
TNM clinical staging | disease stage unresectable Primary | Indication Neoadjuvant Therapy
Item
1. selected stage iib (t3, n0, m0) or iiia (t3, n1-2, m0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.
boolean
C3258246 (UMLS CUI [1])
C0699749 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
TNM clinical staging
Item
2. stage iiib (t4, any n, m0) or (any t, n3, m0) disease.
boolean
C3258246 (UMLS CUI [1])
Physical Examination | Plain chest X-ray | roentgenographic Neoplasm Assessment | Scanning Neoplasm Assessment
Item
physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
boolean
C0031809 (UMLS CUI [1])
C0039985 (UMLS CUI [2])
C0034571 (UMLS CUI [3,1])
C0027651 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C0441633 (UMLS CUI [4,1])
C0027651 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
Congestive heart failure | Angina Pectoris | Hypertensive disease | Age | Multiple gated acquisition scanning | Echocardiography | Multiple gated acquisition scanning Not Applicable | Left ventricular ejection fraction
Item
patients with the clinical diagnosis of congestive heart failure or angina pectoris are not eligible. patients with hypertension or age > 60 years must have a multiple gated acquisition (muga) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (na) if no muga required) and left ventricular ejection fraction (lvef) % must be greater than the institutional lower limit of normal.
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0521317 (UMLS CUI [5])
C0013516 (UMLS CUI [6])
C0521317 (UMLS CUI [7,1])
C1272460 (UMLS CUI [7,2])
C0428772 (UMLS CUI [8])
Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) ≤ 2x the institutional upper limit of normal. these tests must have been performed within 90 days prior to registration.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absolute neutrophil count | Platelet Count measurement
Item
patients must have an absolute neutrophil count (anc) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. these tests must have been performed within 90 days prior to registration.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Zubrod Performance Status
Item
patients must have a performance status of 0-2 by zubrod criteria
boolean
C3714786 (UMLS CUI [1])
Pregnancy | Breast Feeding | Fertility Female Contraceptive methods | Childbearing Potential Urine pregnancy test
Item
pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. a urine pregnancy test is required for women of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0086287 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430056 (UMLS CUI [4,2])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial