ID

16486

Description

Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study; ODM derived from: https://clinicaltrials.gov/show/NCT00229697

Link

https://clinicaltrials.gov/show/NCT00229697

Keywords

Versions (1)
  1. 7/18/16 7/18/16 -
Uploaded on

July 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00229697

English

Eligibility Breast Neoplasms NCT00229697

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic adenocarcinoma of the breast (seetnm staging appendix i) that is er and/or pr positive as determined in local laboratories at each investigator site (central verification of er status will be performed after the patient starts treatment
Description

Breast adenocarcinoma metastatic Estrogen receptor positive | Breast adenocarcinoma metastatic Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1697918
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C1697918
UMLS CUI [2,2]
C0279759
a tissue block from either the metastatic or primary tumor site is required.
Description

Core sample of tissue block Metastatic Neoplasm | Core sample of tissue block primary tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C2316369
UMLS CUI [1,2]
C2939420
UMLS CUI [2,1]
C2316369
UMLS CUI [2,2]
C0677930
who performance status (ps) 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
patients must not be pregnant or breast-feeding. a negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. postmenopausal patients are defined as:
Description

Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative | Perimenopausal state Pregnancy test negative | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3839366
UMLS CUI [4,2]
C0427780
UMLS CUI [5]
C0232970
natural menopause with last menses > 1 year ago,
Description

Natural menopause | Date of last menstrual period

Data type

boolean

Alias
UMLS CUI [1]
C0856856
UMLS CUI [2]
C0425932
radiation induced oophorectomy with last menses > 1 year ago,
Description

Radiation Induced Ovariectomy | Date of last menstrual period

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0029936
UMLS CUI [2]
C0425932
chemotherapy induced menopause with 1 year interval since last menses, or
Description

Chemotherapy Induced Menopause | Interval Since Date of last menstrual

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0025320
UMLS CUI [2,1]
C1272706
UMLS CUI [2,2]
C1711239
UMLS CUI [2,3]
C0425932
serum fsh and lh and plasma estradiol levels in the postmenopausal range for the institution.
Description

Serum follicle stimulating hormone measurement Postmenopause | Serum LH measurement Postmenopause | Plasma estradiol measurement Postmenopause

Data type

boolean

Alias
UMLS CUI [1,1]
C0455276
UMLS CUI [1,2]
C0206159
UMLS CUI [2,1]
C1304771
UMLS CUI [2,2]
C0206159
UMLS CUI [3,1]
C1277973
UMLS CUI [3,2]
C0206159
bilateral oophorectomy
Description

Bilateral oophorectomy

Data type

boolean

Alias
UMLS CUI [1]
C0278321
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
Description

Hormone replacement therapy | Prior Chemotherapy Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C2939420
patients previously treated with a tyrosine kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
Description

Protein-tyrosine kinase inhibitor | Interstitial Lung Disease Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2,1]
C0206062
UMLS CUI [2,2]
C0332120
treatment with lh-rh analog.
Description

Luteinizing Hormone-releasing Hormone Agonist

Data type

boolean

Alias
UMLS CUI [1]
C1518041
laboratory values as follow bilirubin >1.5 times upper limit of normal uln, alanine amino transferase (alt) or aspartate amino transferase (ast) >2.5 times the uln if no demonstrable liver metastases, or >5 times the uln in the presence of liver metastases
Description

Laboratory Results | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0494165
bone marrow function: wbc <1500 mm3
Description

Bone Marrow function | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
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Similar models

Eligibility Breast Neoplasms NCT00229697

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma metastatic Estrogen receptor positive | Breast adenocarcinoma metastatic Progesterone receptor positive
Item
histologically confirmed metastatic adenocarcinoma of the breast (seetnm staging appendix i) that is er and/or pr positive as determined in local laboratories at each investigator site (central verification of er status will be performed after the patient starts treatment
boolean
C1697918 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C1697918 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
Core sample of tissue block Metastatic Neoplasm | Core sample of tissue block primary tumor
Item
a tissue block from either the metastatic or primary tumor site is required.
boolean
C2316369 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
C2316369 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
WHO performance status scale
Item
who performance status (ps) 0-2
boolean
C1298650 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Pregnancy test negative | Perimenopausal state Pregnancy test negative | Postmenopausal state
Item
patients must not be pregnant or breast-feeding. a negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. postmenopausal patients are defined as:
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3839366 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5])
Natural menopause | Date of last menstrual period
Item
natural menopause with last menses > 1 year ago,
boolean
C0856856 (UMLS CUI [1])
C0425932 (UMLS CUI [2])
Radiation Induced Ovariectomy | Date of last menstrual period
Item
radiation induced oophorectomy with last menses > 1 year ago,
boolean
C1522449 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0029936 (UMLS CUI [1,3])
C0425932 (UMLS CUI [2])
Chemotherapy Induced Menopause | Interval Since Date of last menstrual
Item
chemotherapy induced menopause with 1 year interval since last menses, or
boolean
C0392920 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0025320 (UMLS CUI [1,3])
C1272706 (UMLS CUI [2,1])
C1711239 (UMLS CUI [2,2])
C0425932 (UMLS CUI [2,3])
Serum follicle stimulating hormone measurement Postmenopause | Serum LH measurement Postmenopause | Plasma estradiol measurement Postmenopause
Item
serum fsh and lh and plasma estradiol levels in the postmenopausal range for the institution.
boolean
C0455276 (UMLS CUI [1,1])
C0206159 (UMLS CUI [1,2])
C1304771 (UMLS CUI [2,1])
C0206159 (UMLS CUI [2,2])
C1277973 (UMLS CUI [3,1])
C0206159 (UMLS CUI [3,2])
Bilateral oophorectomy
Item
bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone replacement therapy | Prior Chemotherapy Metastatic Neoplasm
Item
patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
boolean
C0282402 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C2939420 (UMLS CUI [2,2])
Protein-tyrosine kinase inhibitor | Interstitial Lung Disease Evidence of
Item
patients previously treated with a tyrosine kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
boolean
C1268567 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Luteinizing Hormone-releasing Hormone Agonist
Item
treatment with lh-rh analog.
boolean
C1518041 (UMLS CUI [1])
Laboratory Results | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
laboratory values as follow bilirubin >1.5 times upper limit of normal uln, alanine amino transferase (alt) or aspartate amino transferase (ast) >2.5 times the uln if no demonstrable liver metastases, or >5 times the uln in the presence of liver metastases
boolean
C1254595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0494165 (UMLS CUI [5])
Bone Marrow function | White Blood Cell Count procedure
Item
bone marrow function: wbc <1500 mm3
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
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