ID

40818

Beskrivning

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT01602380

Länk

https://clinicaltrials.gov/show/NCT01602380

Nyckelord

Versioner (1)
  1. 2020-05-18 2020-05-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hormone Receptor Positive Breast Cancer NCT01602380

Engelsk

Eligibility Hormone Receptor Positive Breast Cancer NCT01602380

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological confirmation of breast cancer in post menopausal women (age >=60). positive hormone receptor status (er +ve and/or pgr +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
Beskrivning

Breast Carcinoma | Postmenopausal state | Age | Tumor tissue sample Primary Estrogen receptor positive | Tumor tissue sample Primary Progesterone receptor positive | Tumor tissue sample metastatic Estrogen receptor positive | Tumor tissue sample metastatic Progesterone receptor positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0475358
UMLS CUI [4,2]
C0205225
UMLS CUI [4,3]
C0279754
UMLS CUI [5,1]
C0475358
UMLS CUI [5,2]
C0205225
UMLS CUI [5,3]
C0279759
UMLS CUI [6,1]
C0475358
UMLS CUI [6,2]
C1522484
UMLS CUI [6,3]
C0279754
UMLS CUI [7,1]
C0475358
UMLS CUI [7,2]
C1522484
UMLS CUI [7,3]
C0279759
either locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) or metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
Beskrivning

Advanced disease Locally | Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
Beskrivning

Measurable lesion Quantity | Non-Measurable Lesion Quantity | Lesion Assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1334988
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1516048
postmenopausal women, fulfilling 1 of:
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
prior bilateral oophorectomy
Beskrivning

Bilateral oophorectomy Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278321
UMLS CUI [1,2]
C0205156
age >60 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
age < 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and fsh and oestradiol in the postmenopausal range
Beskrivning

Age | Amenorrhea Duration | Chemotherapy Absent | Tamoxifen Absent | Toremifene Absent | Ovarian suppression Absent | Follicle Stimulating Hormone Consistent with Postmenopausal state | Estradiol Consistent with Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0039286
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0076836
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0677922
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0733758
UMLS CUI [7,2]
C0332290
UMLS CUI [7,3]
C0232970
UMLS CUI [8,1]
C0014912
UMLS CUI [8,2]
C0332290
UMLS CUI [8,3]
C0232970
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of life-threatening metastatic disease
Beskrivning

Neoplasm Metastasis Life Threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C2826244
any of:
Beskrivning

Exclusion Criteria Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
extensive hepatic involvement
Beskrivning

Hepatic Involvement Extensive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441932
UMLS CUI [1,2]
C0205231
involving brain or meninges
Beskrivning

Brain Involving | Meninges Involving

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C1314939
UMLS CUI [2,1]
C0025285
UMLS CUI [2,2]
C1314939
symptomatic pulmonary lymph spread
Beskrivning

Pulmonary lymph node Spread Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0229749
UMLS CUI [1,2]
C0332261
UMLS CUI [1,3]
C0231220
discrete lung metastases are acceptable if respiratory function is not significantly compromised
Beskrivning

Secondary malignant neoplasm of lung Discrete Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0153676
UMLS CUI [1,2]
C0443299
UMLS CUI [1,3]
C1879533
prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
Beskrivning

Systemic therapy Previous Breast Carcinoma | Exception Cytotoxic Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677881
radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). prior hormonal treatment for breast cancer.
Beskrivning

Therapeutic radiology procedure Incomplete | Prior Hormone Therapy Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205257
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
Beskrivning

Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
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Similar models

Eligibility Hormone Receptor Positive Breast Cancer NCT01602380

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Postmenopausal state | Age | Tumor tissue sample Primary Estrogen receptor positive | Tumor tissue sample Primary Progesterone receptor positive | Tumor tissue sample metastatic Estrogen receptor positive | Tumor tissue sample metastatic Progesterone receptor positive
Item
histological confirmation of breast cancer in post menopausal women (age >=60). positive hormone receptor status (er +ve and/or pgr +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
boolean
C0678222 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0475358 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C0279754 (UMLS CUI [4,3])
C0475358 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0279759 (UMLS CUI [5,3])
C0475358 (UMLS CUI [6,1])
C1522484 (UMLS CUI [6,2])
C0279754 (UMLS CUI [6,3])
C0475358 (UMLS CUI [7,1])
C1522484 (UMLS CUI [7,2])
C0279759 (UMLS CUI [7,3])
Advanced disease Locally | Neoplasm Metastasis
Item
either locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) or metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
Measurable lesion Quantity | Non-Measurable Lesion Quantity | Lesion Assessment
Item
at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
Postmenopausal state
Item
postmenopausal women, fulfilling 1 of:
boolean
C0232970 (UMLS CUI [1])
Bilateral oophorectomy Previous
Item
prior bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Age
Item
age >60 years
boolean
C0001779 (UMLS CUI [1])
Age | Amenorrhea Duration | Chemotherapy Absent | Tamoxifen Absent | Toremifene Absent | Ovarian suppression Absent | Follicle Stimulating Hormone Consistent with Postmenopausal state | Estradiol Consistent with Postmenopausal state
Item
age < 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and fsh and oestradiol in the postmenopausal range
boolean
C0001779 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0076836 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0677922 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0733758 (UMLS CUI [7,1])
C0332290 (UMLS CUI [7,2])
C0232970 (UMLS CUI [7,3])
C0014912 (UMLS CUI [8,1])
C0332290 (UMLS CUI [8,2])
C0232970 (UMLS CUI [8,3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Life Threatening
Item
presence of life-threatening metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Exclusion Criteria Any
Item
any of:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Hepatic Involvement Extensive
Item
extensive hepatic involvement
boolean
C0441932 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
Brain Involving | Meninges Involving
Item
involving brain or meninges
boolean
C0006104 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0025285 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Pulmonary lymph node Spread Symptomatic
Item
symptomatic pulmonary lymph spread
boolean
C0229749 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Secondary malignant neoplasm of lung Discrete Acceptable
Item
discrete lung metastases are acceptable if respiratory function is not significantly compromised
boolean
C0153676 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
Systemic therapy Previous Breast Carcinoma | Exception Cytotoxic Chemotherapy
Item
prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
boolean
C1515119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
Therapeutic radiology procedure Incomplete | Prior Hormone Therapy Breast Carcinoma
Item
radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). prior hormonal treatment for breast cancer.
boolean
C1522449 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
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