ID

26209

Description

Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00661531

Link

https://clinicaltrials.gov/show/NCT00661531

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00661531

English

Eligibility Breast Cancer NCT00661531

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer
Description

Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C2938924
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [3]
C0346993
clinically determined evaluable disease
Description

Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1516986
post-menopausal woman
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.
Description

Benefit clinical Due to Prior antiestrogen therapy | Hormone Therapy Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0814225
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0279797
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
may have had chemotherapy for adjuvant &/or metastatic disease.
Description

Chemotherapy Disease Adjuvant Induced | Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0001552
UMLS CUI [1,4]
C0205263
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0027627
may have had radiation therapy but not to the only site of disease.
Description

Therapeutic radiology procedure | Exception Disease Site only

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1515974
UMLS CUI [2,4]
C0205171
ecog performance status </= 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of > 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
brain metastasis
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus
Description

Thrombophlebitis | Deep Vein Thrombosis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0040046
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0034065
current vaginal bleeding
Description

Vaginal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C2979982
hypercalcemia or hypocalcemia
Description

Hypercalcemia | Hypocalcemia

Data type

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0020598
history of or active hepatic adenoma
Description

Hepatocellular Adenoma

Data type

boolean

Alias
UMLS CUI [1]
C0206669
no other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
Description

Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
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Similar models

Eligibility Breast Cancer NCT00661531

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Secondary malignant neoplasm of female breast
Item
histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer
boolean
C2938924 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3])
Evaluable Disease
Item
clinically determined evaluable disease
boolean
C1516986 (UMLS CUI [1])
Postmenopausal state
Item
post-menopausal woman
boolean
C0232970 (UMLS CUI [1])
Benefit clinical Due to Prior antiestrogen therapy | Hormone Therapy Quantity failed
Item
previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.
boolean
C0814225 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0279797 (UMLS CUI [1,4])
C0279025 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Chemotherapy Disease Adjuvant Induced | Chemotherapy Neoplasm Metastasis
Item
may have had chemotherapy for adjuvant &/or metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0001552 (UMLS CUI [1,3])
C0205263 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Therapeutic radiology procedure | Exception Disease Site only
Item
may have had radiation therapy but not to the only site of disease.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
ECOG performance status
Item
ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of > 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
brain metastasis
boolean
C0220650 (UMLS CUI [1])
Thrombophlebitis | Deep Vein Thrombosis | Pulmonary Embolism
Item
prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus
boolean
C0040046 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
Vaginal Hemorrhage
Item
current vaginal bleeding
boolean
C2979982 (UMLS CUI [1])
Hypercalcemia | Hypocalcemia
Item
hypercalcemia or hypocalcemia
boolean
C0020437 (UMLS CUI [1])
C0020598 (UMLS CUI [2])
Hepatocellular Adenoma
Item
history of or active hepatic adenoma
boolean
C0206669 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
no other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
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