ID

40818

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01602380

Stichworte

Versionen (1)
  1. 18.05.20 18.05.20 -
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See clinicaltrials.gov

Hochgeladen am

18. Mai 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hormone Receptor Positive Breast Cancer NCT01602380

Englisch

Eligibility Hormone Receptor Positive Breast Cancer NCT01602380

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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)
Beschreibung

Advanced disease Locally | Neoplasm Metastasis

Datentyp

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.
Beschreibung

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

Datentyp

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:
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
prior bilateral oophorectomy
Beschreibung

Bilateral oophorectomy Previous

Datentyp

boolean

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

Age

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Neoplasm Metastasis Life Threatening

Datentyp

boolean

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

Exclusion Criteria Any

Datentyp

boolean

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

Hepatic Involvement Extensive

Datentyp

boolean

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

Brain Involving | Meninges Involving

Datentyp

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
Beschreibung

Pulmonary lymph node Spread Symptomatic

Datentyp

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
Beschreibung

Secondary malignant neoplasm of lung Discrete Acceptable

Datentyp

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)
Beschreibung

Systemic therapy Previous Breast Carcinoma | Exception Cytotoxic Chemotherapy

Datentyp

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.
Beschreibung

Therapeutic radiology procedure Incomplete | Prior Hormone Therapy Breast Carcinoma

Datentyp

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).
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Hormone Receptor Positive Breast Cancer NCT01602380

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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