ID

19701

Descripción

Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00375752

Link

https://clinicaltrials.gov/show/NCT00375752

Palabras clave

Versiones (1)
  1. 23/1/17 23/1/17 -
Subido en

23 de enero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Neoplasms DRKS00003644 NCT00375752

Inglés

Eligibility Breast Neoplasms NCT00375752

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive
Descripción

Postmenopausal state | Invasive carcinoma of breast Primary Core needle biopsy | Estrogen receptor positive tumor | Progesterone receptor positive tumor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C1318309
UMLS CUI [3]
C1562312
UMLS CUI [4]
C1562928
clinical stage t1c (size ≥ 1.5 cm), t2, t3, t4a, b, c, n0 or n1, m0 (tnm classification). according to the modified recist criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions).
Descripción

Tumor size TNM clinical staging | Tumor size Measurable Mammography | Target Lesion Identification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C0024671
UMLS CUI [3]
C2986546
tumor measurable by mammography, sonography and clinical examination.
Descripción

Neoplasm Measurable Mammography | Ultrasonography | Physical Examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C0024671
UMLS CUI [2]
C0041618
UMLS CUI [3]
C0031809
adequate bone marrow, renal and hepatic function
Descripción

Bone Marrow function | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
good health status (ecog performance status of 0, 1 or 2)
Descripción

health good ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with letrozole or bisphosphonates. prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (brm's), endocrine therapy other than letrozole (including steroids), and radiotherapy. patients who have received hormone replacement therapy (hrt) will not be excluded, provided that hrt is discontinued at least 2 weeks prior to entry into the study.
Descripción

letrozole | Diphosphonates | Breast Cancer Therapeutic Procedure | Chemotherapy | Immunotherapy | Biological Response Modifier Therapy | Hormone Therapy | Steroids | Therapeutic radiology procedure | Hormone replacement therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0246421
UMLS CUI [2]
C0012544
UMLS CUI [3]
C1511300
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0005527
UMLS CUI [7]
C0279025
UMLS CUI [8]
C0038317
UMLS CUI [9]
C1522449
UMLS CUI [10]
C0282402
patients with unstable angina, or uncontrolled cardiac disease (e.g. class iii and iv new york heart association's functional classification, see appendix 9) or uncontrolled endocrine disorders.
Descripción

Angina, Unstable | Heart Disease Uncontrolled New York Heart Association Classification | Endocrine System Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C1275491
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0205318
evidence of inflammatory breast cancer or distant metastasis.
Descripción

Inflammatory Breast Carcinoma Evidence of | Distant metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278601
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C1275402
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
Descripción

Tooth problem | Infection of tooth | Jaw infection Maxilla | Jaw infection Mandible | Dental trauma | Osteonecrosis of jaw | exposed bone of oral vestibule | Dental Procedure Healing Slow | Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0576962
UMLS CUI [2]
C0877046
UMLS CUI [3,1]
C1400570
UMLS CUI [3,2]
C0024947
UMLS CUI [4,1]
C1400570
UMLS CUI [4,2]
C0024687
UMLS CUI [5]
C1301685
UMLS CUI [6]
C2711248
UMLS CUI [7]
C2013525
UMLS CUI [8,1]
C0011331
UMLS CUI [8,2]
C0043240
UMLS CUI [8,3]
C0439834
UMLS CUI [9]
C0204324
UMLS CUI [10]
C0407713
UMLS CUI [11]
C0040440
UMLS CUI [12]
C0011370
history of diseases with influence on bone metabolism, such as paget's disease, osteogenesis imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry
Descripción

Disease Affecting bone metabolism | Paget's Disease | Osteogenesis Imperfecta | Primary Hyperthyroidism | Secondary hyperthyroidism

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
UMLS CUI [2]
C1368019
UMLS CUI [3]
C0029434
UMLS CUI [4]
C3714618
UMLS CUI [5]
C1095928
other protocol-defined inclusion/exclusion criteria may apply
Descripción

Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Neoplasms NCT00375752

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Invasive carcinoma of breast Primary Core needle biopsy | Estrogen receptor positive tumor | Progesterone receptor positive tumor
Item
postmenopausal women with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (er) and / or progesterone (pgr) positive
boolean
C0232970 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
C1562312 (UMLS CUI [3])
C1562928 (UMLS CUI [4])
Tumor size TNM clinical staging | Tumor size Measurable Mammography | Target Lesion Identification
Item
clinical stage t1c (size ≥ 1.5 cm), t2, t3, t4a, b, c, n0 or n1, m0 (tnm classification). according to the modified recist criteria, tumors of size ≥ 1.5 cm are considered measurable by mammography and can be determined as target lesions).
boolean
C0475440 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0024671 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3])
Neoplasm Measurable Mammography | Ultrasonography | Physical Examination
Item
tumor measurable by mammography, sonography and clinical examination.
boolean
C0027651 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal and hepatic function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
health good ECOG performance status
Item
good health status (ecog performance status of 0, 1 or 2)
boolean
C1277245 (UMLS CUI [1,1])
C1520224 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
letrozole | Diphosphonates | Breast Cancer Therapeutic Procedure | Chemotherapy | Immunotherapy | Biological Response Modifier Therapy | Hormone Therapy | Steroids | Therapeutic radiology procedure | Hormone replacement therapy
Item
prior treatment with letrozole or bisphosphonates. prior and concomitant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers (brm's), endocrine therapy other than letrozole (including steroids), and radiotherapy. patients who have received hormone replacement therapy (hrt) will not be excluded, provided that hrt is discontinued at least 2 weeks prior to entry into the study.
boolean
C0246421 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
C1511300 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0005527 (UMLS CUI [6])
C0279025 (UMLS CUI [7])
C0038317 (UMLS CUI [8])
C1522449 (UMLS CUI [9])
C0282402 (UMLS CUI [10])
Angina, Unstable | Heart Disease Uncontrolled New York Heart Association Classification | Endocrine System Disease Uncontrolled
Item
patients with unstable angina, or uncontrolled cardiac disease (e.g. class iii and iv new york heart association's functional classification, see appendix 9) or uncontrolled endocrine disorders.
boolean
C0002965 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0014130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Inflammatory Breast Carcinoma Evidence of | Distant metastasis
Item
evidence of inflammatory breast cancer or distant metastasis.
boolean
C0278601 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1275402 (UMLS CUI [2])
Tooth problem | Infection of tooth | Jaw infection Maxilla | Jaw infection Mandible | Dental trauma | Osteonecrosis of jaw | exposed bone of oral vestibule | Dental Procedure Healing Slow | Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implantation
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3,1])
C0024947 (UMLS CUI [3,2])
C1400570 (UMLS CUI [4,1])
C0024687 (UMLS CUI [4,2])
C1301685 (UMLS CUI [5])
C2711248 (UMLS CUI [6])
C2013525 (UMLS CUI [7])
C0011331 (UMLS CUI [8,1])
C0043240 (UMLS CUI [8,2])
C0439834 (UMLS CUI [8,3])
C0204324 (UMLS CUI [9])
C0407713 (UMLS CUI [10])
C0040440 (UMLS CUI [11])
C0011370 (UMLS CUI [12])
Disease Affecting bone metabolism | Paget's Disease | Osteogenesis Imperfecta | Primary Hyperthyroidism | Secondary hyperthyroidism
Item
history of diseases with influence on bone metabolism, such as paget's disease, osteogenesis imperfecta, and primary or secondary hyperthyroidism within the 12 months prior to study entry
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C1368019 (UMLS CUI [2])
C0029434 (UMLS CUI [3])
C3714618 (UMLS CUI [4])
C1095928 (UMLS CUI [5])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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