ID

42338

Beskrivning

Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00200174

Länk

https://clinicaltrials.gov/show/NCT00200174

Nyckelord

Versioner (2)
  1. 2016-02-01 2016-02-01 -
  2. 2021-06-18 2021-06-18 -
Rättsinnehavare

Memorial Sloan Kettering Cancer Center

Uppladdad den

18 juni 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00200174

Engelsk

Eligibility Breast Cancer NCT00200174

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women with a history of ajcc stage 0, i, ii or iii breast cancer, with no clinical evidence of disease, after completion of all planned adjuvant therapy. patients must not have received anti-estrogen therapy as part of their adjuvant treatment. patients with a history of invasive er- and/or pr-positive breast cancer are eligible only if they have not received an anti-estrogen as part of adjuvant therapy, and they are at least 2 years from the time of their primary surgery.
Beskrivning

Breast Cancer Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0441915
UMLS CUI [1,3]
C0677850
UMLS CUI [1,4]
C0014930
UMLS CUI [2,1]
C1616831
UMLS CUI [2,2]
C0014930
UMLS CUI [2,3]
C0543467
UMLS CUI [2,4]
C2826303
patients must have completed all planned adjuvant therapy, including surgery, chemotherapy, and radiation therapy, at least 4 weeks prior to treatment. there is no limit as to the amount of time that may have passed since completion of adjuvant therapy and initiation of treatment.
Beskrivning

Adjuvant therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C0851346
patients must be postmenopausal, as defined by either:
Beskrivning

Postmenopausal status

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
1. no spontaneous menses for at least 5 years; women who have had a hysterectomy in this group, but have intact ovaries must have luteinizing hormone (lh) and follicle-stimulating hormone (fsh) levels within the postmenopausal range
Beskrivning

Postmenopausal status I

Datatyp

boolean

Alias
UMLS CUI [1]
C0025344
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0202123
UMLS CUI [2,3]
C0202022
2. spontaneous menses within the past 5 years, but amenorrheic (e.g. spontaneous or secondary to chemotherapy, radiation therapy or hysterectomy) for at least 12 months, and luteinizing hormone (lh) and follicle-stimulating hormone (fsh) levels within the postmenopausal range
Beskrivning

Postmenopausal Status II

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0025344
UMLS CUI [1,3]
C0202123
UMLS CUI [1,4]
C0202022
3. bilateral oophorectomy
Beskrivning

Postmenopausal status III

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
patients must have a history of breast cancer confirmed by the department of pathology at memorial sloan-kettering cancer center.
Beskrivning

Breast cancer confirmed by Pathology

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205469
patients must be at least 18 years old, and must be able to give written informed consent.
Beskrivning

age and informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
karnofsky performance status > 80%.
Beskrivning

karnofsky performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
laboratory parameters:
Beskrivning

laboratory parameters

Datatyp

boolean

Alias
UMLS CUI [1]
C0022885
wbc =>3.0 x 106 cells/ml serum bilirubin <= 1.5 mg/dl serum creatinine <= 1.5 mg/dl serum ast (sgot) <= 2x upper institutional normal cea and ca15-3 within institutional normal limits
Beskrivning

labaratory parameters

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201933
UMLS CUI [6]
C1254980
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of bilateral mastectomy.
Beskrivning

bilateral mastectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0191877
prior history of ovarian or endometrial cancer.
Beskrivning

ovarian or endometrial cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0029925
UMLS CUI [2]
C0476089
prior or current history of osteoporosis, as defined by a lumbar-spine bone mineral density < 2.5 sd below the mean value for normal premenopausal women.
Beskrivning

osteoporosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0177804
UMLS CUI [1,2]
C3887615
use of bisphosphonates or calcitonin within the past 3 months.
Beskrivning

Pharmacotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0201924
prior history of venous thrombosis or pulmonary embolism.
Beskrivning

venous thrombosis or pulmonary embolism

Datatyp

boolean

Alias
UMLS CUI [1]
C0042487
UMLS CUI [2]
C0034065
patients with unstable angina or new york heart association class iii or iv heart disease.
Beskrivning

Cardiac status

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C1319796
UMLS CUI [3]
C1319795
prior hormonal therapy within the past 3 months.
Beskrivning

hormonal therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0877050
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Similar models

Eligibility Breast Cancer NCT00200174

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Cancer Status
Item
postmenopausal women with a history of ajcc stage 0, i, ii or iii breast cancer, with no clinical evidence of disease, after completion of all planned adjuvant therapy. patients must not have received anti-estrogen therapy as part of their adjuvant treatment. patients with a history of invasive er- and/or pr-positive breast cancer are eligible only if they have not received an anti-estrogen as part of adjuvant therapy, and they are at least 2 years from the time of their primary surgery.
boolean
C0232970 (UMLS CUI [1,1])
C0441915 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0014930 (UMLS CUI [1,4])
C1616831 (UMLS CUI [2,1])
C0014930 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C2826303 (UMLS CUI [2,4])
Adjuvant therapy
Item
patients must have completed all planned adjuvant therapy, including surgery, chemotherapy, and radiation therapy, at least 4 weeks prior to treatment. there is no limit as to the amount of time that may have passed since completion of adjuvant therapy and initiation of treatment.
boolean
C0677850 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0851346 (UMLS CUI [1,4])
Postmenopausal status
Item
patients must be postmenopausal, as defined by either:
boolean
C0232970 (UMLS CUI [1])
Postmenopausal status I
Item
1. no spontaneous menses for at least 5 years; women who have had a hysterectomy in this group, but have intact ovaries must have luteinizing hormone (lh) and follicle-stimulating hormone (fsh) levels within the postmenopausal range
boolean
C0025344 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0202123 (UMLS CUI [2,2])
C0202022 (UMLS CUI [2,3])
Postmenopausal Status II
Item
2. spontaneous menses within the past 5 years, but amenorrheic (e.g. spontaneous or secondary to chemotherapy, radiation therapy or hysterectomy) for at least 12 months, and luteinizing hormone (lh) and follicle-stimulating hormone (fsh) levels within the postmenopausal range
boolean
C0002453 (UMLS CUI [1,1])
C0025344 (UMLS CUI [1,2])
C0202123 (UMLS CUI [1,3])
C0202022 (UMLS CUI [1,4])
Postmenopausal status III
Item
3. bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Breast cancer confirmed by Pathology
Item
patients must have a history of breast cancer confirmed by the department of pathology at memorial sloan-kettering cancer center.
boolean
C0678222 (UMLS CUI [1,1])
C0205469 (UMLS CUI [1,2])
age and informed consent
Item
patients must be at least 18 years old, and must be able to give written informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
karnofsky performance status
Item
karnofsky performance status > 80%.
boolean
C0206065 (UMLS CUI [1])
laboratory parameters
Item
laboratory parameters:
boolean
C0022885 (UMLS CUI [1])
labaratory parameters
Item
wbc =>3.0 x 106 cells/ml serum bilirubin <= 1.5 mg/dl serum creatinine <= 1.5 mg/dl serum ast (sgot) <= 2x upper institutional normal cea and ca15-3 within institutional normal limits
boolean
C0023508 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201933 (UMLS CUI [5])
C1254980 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
bilateral mastectomy
Item
prior history of bilateral mastectomy.
boolean
C0191877 (UMLS CUI [1])
ovarian or endometrial cancer
Item
prior history of ovarian or endometrial cancer.
boolean
C0029925 (UMLS CUI [1])
C0476089 (UMLS CUI [2])
osteoporosis
Item
prior or current history of osteoporosis, as defined by a lumbar-spine bone mineral density < 2.5 sd below the mean value for normal premenopausal women.
boolean
C0177804 (UMLS CUI [1,1])
C3887615 (UMLS CUI [1,2])
Pharmacotherapy
Item
use of bisphosphonates or calcitonin within the past 3 months.
boolean
C0012544 (UMLS CUI [1])
C0201924 (UMLS CUI [2])
venous thrombosis or pulmonary embolism
Item
prior history of venous thrombosis or pulmonary embolism.
boolean
C0042487 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Cardiac status
Item
patients with unstable angina or new york heart association class iii or iv heart disease.
boolean
C0002965 (UMLS CUI [1])
C1319796 (UMLS CUI [2])
C1319795 (UMLS CUI [3])
hormonal therapy
Item
prior hormonal therapy within the past 3 months.
boolean
C0877050 (UMLS CUI [1])
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