ID

18123

Description

Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00532623

Link

https://clinicaltrials.gov/show/NCT00532623

Keywords

Versions (2)
  1. 10/20/16 10/20/16 -
  2. 10/21/16 10/21/16 -
Uploaded on

October 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00532623

English

Eligibility Metastatic Breast Cancer NCT00532623

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of stage iv or recurrent breast cancer.
Description

Carcinoma breast stage IV | Breast cancer recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C0278493
previous anthracycline and/or taxane and/or capecitabine chemotherapy in adjuvant and metastatic setting.
Description

Chemotherapy, Adjuvant | Chemotherapy Carcinoma breast stage IV | Anthracyclines | taxane | capecitabine

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C3665472
UMLS CUI [2,2]
C0278488
UMLS CUI [3]
C0282564
UMLS CUI [4]
C0215136
UMLS CUI [5]
C0671970
previous hormonal therapy in adjuvant and metastatic setting.
Description

Hormone Therapy Adjuvant | Hormone Therapy Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0278488
prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
Description

prior radiation therapy | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1513041
no other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
Description

cancer treatment | Therapeutic radiology procedure | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
performance status of 0, 1, 2 on the ecog criteria.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
clinically measurable disease, defined as unidimensionally measurable lesions with clearly defined margins on x-ray, ct scan, mri or physical examination. lesions serving as measurable disease must be at least 1cm by 1cm, as defined by x-ray, ct scan, mri,or physical examination.
Description

Measurable Disease Clinical | Measurable Lesion Linear | Circumscribed lesion | Plain x-ray | X-Ray Computed Tomography | Magnetic Resonance Imaging | Physical Examination | Lesion size

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0205132
UMLS CUI [3]
C1268666
UMLS CUI [4]
C1306645
UMLS CUI [5]
C0040405
UMLS CUI [6]
C0024485
UMLS CUI [7]
C0031809
UMLS CUI [8]
C0449453
estimated life expectancy of at least 12 weeks.
Description

Life Expectancy Estimated

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0750572
patient compliance that allow adequate follow-up.
Description

Compliance behavior Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1522577
adequate hematologic (wbc count3,000/mm3, platelet count100,000/mm3), hepatic (bilirubin level1.5 mg/dl, ast, alt3xuln), and renal (creatinine concentration 1.5 mg/dl) function.
Description

Hematologic function | White Blood Cell Count procedure | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0232804
UMLS CUI [9]
C0201976
informed consent from patient or patient's relative.
Description

Informed Consent | Informed Consent Relative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0080103
females at least 18 years of age.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
childbearing women should use non-hormonal contraceptive method.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy > 3 for recurrent or stage iv disease second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
Description

Prior Chemotherapy Quantity Breast cancer recurrent | Prior Chemotherapy Quantity Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278493
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0278488
second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
Description

Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Malignant Neoplasm Treated

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0851140
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1522326
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Similar models

Eligibility Metastatic Breast Cancer NCT00532623

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma breast stage IV | Breast cancer recurrent
Item
histologic or cytologic diagnosis of stage iv or recurrent breast cancer.
boolean
C0278488 (UMLS CUI [1])
C0278493 (UMLS CUI [2])
Chemotherapy, Adjuvant | Chemotherapy Carcinoma breast stage IV | Anthracyclines | taxane | capecitabine
Item
previous anthracycline and/or taxane and/or capecitabine chemotherapy in adjuvant and metastatic setting.
boolean
C0085533 (UMLS CUI [1])
C3665472 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
C0282564 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
C0671970 (UMLS CUI [5])
Hormone Therapy Adjuvant | Hormone Therapy Carcinoma breast stage IV
Item
previous hormonal therapy in adjuvant and metastatic setting.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
prior radiation therapy | Measurable Disease
Item
prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
boolean
C0279134 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
cancer treatment | Therapeutic radiology procedure | Immunotherapy
Item
no other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study.
boolean
C0920425 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
ECOG performance status
Item
performance status of 0, 1, 2 on the ecog criteria.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Clinical | Measurable Lesion Linear | Circumscribed lesion | Plain x-ray | X-Ray Computed Tomography | Magnetic Resonance Imaging | Physical Examination | Lesion size
Item
clinically measurable disease, defined as unidimensionally measurable lesions with clearly defined margins on x-ray, ct scan, mri or physical examination. lesions serving as measurable disease must be at least 1cm by 1cm, as defined by x-ray, ct scan, mri,or physical examination.
boolean
C1513041 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C1268666 (UMLS CUI [3])
C1306645 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
C0031809 (UMLS CUI [7])
C0449453 (UMLS CUI [8])
Life Expectancy Estimated
Item
estimated life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Compliance behavior Follow-up
Item
patient compliance that allow adequate follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Hematologic function | White Blood Cell Count procedure | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate hematologic (wbc count3,000/mm3, platelet count100,000/mm3), hepatic (bilirubin level1.5 mg/dl, ast, alt3xuln), and renal (creatinine concentration 1.5 mg/dl) function.
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0232804 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
Informed Consent | Informed Consent Relative
Item
informed consent from patient or patient's relative.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0080103 (UMLS CUI [2,2])
Gender | Age
Item
females at least 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
childbearing women should use non-hormonal contraceptive method.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Quantity Breast cancer recurrent | Prior Chemotherapy Quantity Carcinoma breast stage IV
Item
previous chemotherapy > 3 for recurrent or stage iv disease second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278493 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278488 (UMLS CUI [2,3])
Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Malignant Neoplasm Treated
Item
second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
boolean
C0751623 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
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