ID

16316

Beschreibung

Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole; ODM derived from: https://clinicaltrials.gov/show/NCT00237224

Link

https://clinicaltrials.gov/show/NCT00237224

Stichworte

Versionen (1)
  1. 11.07.16 11.07.16 -
Hochgeladen am

11. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00237224

Englisch

Eligibility Breast Cancer NCT00237224

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. postmenopausal woman able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
Beschreibung

Postmenopausal state | Compliance behavior Study Protocol | Primary invasive malignant neoplasm of female breast | Core needle biopsy | Estrogen receptor positive tumor | Progesterone receptor positive tumor | biopsy immunohistochemistry | Epithelial Cells Malignant Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C2348563
UMLS CUI [3]
C4076461
UMLS CUI [4]
C1318309
UMLS CUI [5]
C1562312
UMLS CUI [6]
C1562928
UMLS CUI [7]
C2210384
UMLS CUI [8,1]
C0014597
UMLS CUI [8,2]
C0205282
UMLS CUI [8,3]
C1446409
2. clinical stage *t2, t3, t4a,b,c, n0, 1 or 2, m0
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
clinical stage t2 tumors which in the investigators opinion would not be eligible for breast-conserving surgery.
Beschreibung

Tumor stage T2 | eligible Breast-Conserving Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0475373
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0917927
3. post menopausal status defined by one of the following:
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
no spontaneous menses for at least 1 year, in women > 55 years.
Beschreibung

Menstruation Spontaneous | Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025344
UMLS CUI [1,2]
C0205359
UMLS CUI [2]
C0001779
spontaneous menses within the past 1 year but amenorrhoeic in women ≤ 55 years (e.g. spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (lh y fsh levels > 40 iu/l) or postmenopausal estradiol levels (< 5 ng/dl) or according to the definition of "postmenopausal range" for the laboratory involved.
Beschreibung

Menses Spontaneous | Amenorrhea | Age | Hysterectomy Related Spontaneous | Hysterectomy Secondary to | gonadotrophin level Postmenopausal | Luteinizing hormone measurement | Follicle stimulating hormone measurement | Estradiol level Postmenopausal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025344
UMLS CUI [1,2]
C0205359
UMLS CUI [2]
C0002453
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0020699
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0205359
UMLS CUI [5,1]
C0020699
UMLS CUI [5,2]
C0175668
UMLS CUI [6,1]
C0542494
UMLS CUI [6,2]
C0232970
UMLS CUI [7]
C0202123
UMLS CUI [8]
C0202022
UMLS CUI [9,1]
C1443016
UMLS CUI [9,2]
C0232970
bilateral oophorectomy. (prior to the diagnosis of breast cancer).
Beschreibung

Bilateral oophorectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0278321
4. tumor measurable by clinical examination, mammography and ultrasound.
Beschreibung

Measurable Disease | examination; clinical | Mammography | Ultrasonics (sound)

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1456356
UMLS CUI [3]
C0024671
UMLS CUI [4]
C1456803
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with letrozole or tamoxifen.
Beschreibung

letrozole | Tamoxifen

Datentyp

boolean

Alias
UMLS CUI [1]
C0246421
UMLS CUI [2]
C0039286
2. uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, cushing's syndrome, addison's disease (treated or untreated).
Beschreibung

Endocrine System Diseases Uncontrolled | Diabetes Mellitus | Hypothyroidism | Hyperthyroidism | Cushing Syndrome | Addison Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0020676
UMLS CUI [4]
C0020550
UMLS CUI [5]
C0010481
UMLS CUI [6]
C0001403
3. patients with unstable, angina, or uncontrolled cardiac disease (e.g. class iii or iv new york heart association's functional classification).
Beschreibung

Angina, Unstable | Heart Diseases Uncontrolled | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1275491
4. patients with bilateral breast tumors
Beschreibung

bilateral breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
5. patients who are eligible for breast conserving surgery
Beschreibung

Patients eligible Breast-Conserving Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0917927
6. evidence of inflammatory breast cancer or distant metastasis.
Beschreibung

Inflammatory Breast Carcinoma Evidence | Distant metastasis Evidence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278601
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1275402
UMLS CUI [2,2]
C0332120
other protocol-defined inclusion/exclusion criteria may apply.
Beschreibung

criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Breast Cancer NCT00237224

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Compliance behavior Study Protocol | Primary invasive malignant neoplasm of female breast | Core needle biopsy | Estrogen receptor positive tumor | Progesterone receptor positive tumor | biopsy immunohistochemistry | Epithelial Cells Malignant Positive
Item
1. postmenopausal woman able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells.
boolean
C0232970 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C4076461 (UMLS CUI [3])
C1318309 (UMLS CUI [4])
C1562312 (UMLS CUI [5])
C1562928 (UMLS CUI [6])
C2210384 (UMLS CUI [7])
C0014597 (UMLS CUI [8,1])
C0205282 (UMLS CUI [8,2])
C1446409 (UMLS CUI [8,3])
TNM clinical staging
Item
2. clinical stage *t2, t3, t4a,b,c, n0, 1 or 2, m0
boolean
C3258246 (UMLS CUI [1])
Tumor stage T2 | eligible Breast-Conserving Surgery
Item
clinical stage t2 tumors which in the investigators opinion would not be eligible for breast-conserving surgery.
boolean
C0475373 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
Postmenopausal state
Item
3. post menopausal status defined by one of the following:
boolean
C0232970 (UMLS CUI [1])
Menstruation Spontaneous | Age
Item
no spontaneous menses for at least 1 year, in women > 55 years.
boolean
C0025344 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Menses Spontaneous | Amenorrhea | Age | Hysterectomy Related Spontaneous | Hysterectomy Secondary to | gonadotrophin level Postmenopausal | Luteinizing hormone measurement | Follicle stimulating hormone measurement | Estradiol level Postmenopausal
Item
spontaneous menses within the past 1 year but amenorrhoeic in women ≤ 55 years (e.g. spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (lh y fsh levels > 40 iu/l) or postmenopausal estradiol levels (< 5 ng/dl) or according to the definition of "postmenopausal range" for the laboratory involved.
boolean
C0025344 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0002453 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0020699 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0205359 (UMLS CUI [4,3])
C0020699 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0542494 (UMLS CUI [6,1])
C0232970 (UMLS CUI [6,2])
C0202123 (UMLS CUI [7])
C0202022 (UMLS CUI [8])
C1443016 (UMLS CUI [9,1])
C0232970 (UMLS CUI [9,2])
Bilateral oophorectomy
Item
bilateral oophorectomy. (prior to the diagnosis of breast cancer).
boolean
C0278321 (UMLS CUI [1])
Measurable Disease | examination; clinical | Mammography | Ultrasonics (sound)
Item
4. tumor measurable by clinical examination, mammography and ultrasound.
boolean
C1513041 (UMLS CUI [1])
C1456356 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
C1456803 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
letrozole | Tamoxifen
Item
1. prior treatment with letrozole or tamoxifen.
boolean
C0246421 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
Endocrine System Diseases Uncontrolled | Diabetes Mellitus | Hypothyroidism | Hyperthyroidism | Cushing Syndrome | Addison Disease
Item
2. uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, cushing's syndrome, addison's disease (treated or untreated).
boolean
C0014130 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0010481 (UMLS CUI [5])
C0001403 (UMLS CUI [6])
Angina, Unstable | Heart Diseases Uncontrolled | New York Heart Association Classification
Item
3. patients with unstable, angina, or uncontrolled cardiac disease (e.g. class iii or iv new york heart association's functional classification).
boolean
C0002965 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1275491 (UMLS CUI [3])
bilateral breast cancer
Item
4. patients with bilateral breast tumors
boolean
C0281267 (UMLS CUI [1])
Patients eligible Breast-Conserving Surgery
Item
5. patients who are eligible for breast conserving surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0917927 (UMLS CUI [1,3])
Inflammatory Breast Carcinoma Evidence | Distant metastasis Evidence
Item
6. evidence of inflammatory breast cancer or distant metastasis.
boolean
C0278601 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1275402 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0243161 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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