ID

13387

Description

Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00038402

Link

https://clinicaltrials.gov/show/NCT00038402

Keywords

Versions (1)
  1. 2/10/16 2/10/16 -
Uploaded on

February 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00038402

English

Eligibility Breast Cancer NCT00038402

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast with t2-3 (greater than 2 cm), n0-1, m0 will be eligible. patients with t1n1 (after histological confirmation of nodal disease) will be eligible for the study.
Description

invasive breast carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0205281
2. histologic confirmation of invasive tumor will be done by core needle biopsy. on the tissue obtained, estrogen and progesterone receptors (er/pr) as well as her-2/neu (will be determined by immunohistochemistry (ih) and/or fluorescence in situ hybridization (fish)) and p53 will be done (for research evaluation). tumor proliferation rate will be evaluable by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67. residual tumor tissue will be saved in the tissue bank for further future studies.
Description

histologic confirmation and ER PR status

Data type

boolean

Alias
UMLS CUI [1,1]
C0205462
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0449443
UMLS CUI [2,2]
C0021044
3. all patients who are her-2/neu positive will be eligible for the study. her-2/neu positivity for protocol purposes will be determined by ihc and patients with tumors that are 3+ or fish + will be eligible.
Description

her-2 neu positivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0242957
UMLS CUI [1,2]
C1446409
4. patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
5. all patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >1,500/mm3, and platelet count > 100,000 mm3. patients must have adequate liver function, with a bilirubin within normal laboratory values. in addition, patients should have adequate renal function, defined as serum creatinine <2.0 mg%.
Description

adequate bone marrow liver and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201976
6. patients must have a normal cardiac ejection fraction as determined by baseline echocardiogram. tape must be saved for review by central cardiologist.
Description

cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
7. patients who underwent biopsy outside will be eligible if they had a measurable residual tumor.
Description

measurable residual tumor

Data type

boolean

Alias
UMLS CUI [1]
C0475286
8. patients with multicentric disease and extensive ductal carcinoma in situ (dcis) will be eligible for study.
Description

multicentric disease and extensive ductal carcinoma in situ

Data type

boolean

Alias
UMLS CUI [1]
C2986664
UMLS CUI [2]
C0007124
9. patients with a history of cardiac arrhythmia will be eligible for study after being cleared by cardiology.
Description

cardiac arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with t1n0 disease are not eligible for the study.
Description

T1N0 disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0475372
UMLS CUI [1,2]
C1321215
2. those patients with history of other invasive malignancies will be excluded except non-melanoma skin cancer and non-invasive cervical cancer.
Description

other invasive malignancies

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205281
3. patients with a history of congestive heart failure will be excluded.
Description

history of congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
4. patients who had surgical therapy prior to referral will be ineligible.
Description

surgical therapy

Data type

boolean

Alias
UMLS CUI [1]
C0543467
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Similar models

Eligibility Breast Cancer NCT00038402

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
invasive breast carcinoma
Item
1. all patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast with t2-3 (greater than 2 cm), n0-1, m0 will be eligible. patients with t1n1 (after histological confirmation of nodal disease) will be eligible for the study.
boolean
C0006826 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
histologic confirmation and ER PR status
Item
2. histologic confirmation of invasive tumor will be done by core needle biopsy. on the tissue obtained, estrogen and progesterone receptors (er/pr) as well as her-2/neu (will be determined by immunohistochemistry (ih) and/or fluorescence in situ hybridization (fish)) and p53 will be done (for research evaluation). tumor proliferation rate will be evaluable by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67. residual tumor tissue will be saved in the tissue bank for further future studies.
boolean
C0205462 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0449443 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
her-2 neu positivity
Item
3. all patients who are her-2/neu positive will be eligible for the study. her-2/neu positivity for protocol purposes will be determined by ihc and patients with tumors that are 3+ or fish + will be eligible.
boolean
C0242957 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
informed consent
Item
4. patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
boolean
C0021430 (UMLS CUI [1])
adequate bone marrow liver and renal function
Item
5. all patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >1,500/mm3, and platelet count > 100,000 mm3. patients must have adequate liver function, with a bilirubin within normal laboratory values. in addition, patients should have adequate renal function, defined as serum creatinine <2.0 mg%.
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
cardiac ejection fraction
Item
6. patients must have a normal cardiac ejection fraction as determined by baseline echocardiogram. tape must be saved for review by central cardiologist.
boolean
C0232174 (UMLS CUI [1])
measurable residual tumor
Item
7. patients who underwent biopsy outside will be eligible if they had a measurable residual tumor.
boolean
C0475286 (UMLS CUI [1])
multicentric disease and extensive ductal carcinoma in situ
Item
8. patients with multicentric disease and extensive ductal carcinoma in situ (dcis) will be eligible for study.
boolean
C2986664 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
cardiac arrhythmia
Item
9. patients with a history of cardiac arrhythmia will be eligible for study after being cleared by cardiology.
boolean
C0003811 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
T1N0 disease
Item
1. patients with t1n0 disease are not eligible for the study.
boolean
C0475372 (UMLS CUI [1,1])
C1321215 (UMLS CUI [1,2])
other invasive malignancies
Item
2. those patients with history of other invasive malignancies will be excluded except non-melanoma skin cancer and non-invasive cervical cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
history of congestive heart failure
Item
3. patients with a history of congestive heart failure will be excluded.
boolean
C0018802 (UMLS CUI [1])
surgical therapy
Item
4. patients who had surgical therapy prior to referral will be ineligible.
boolean
C0543467 (UMLS CUI [1])
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