ID

43578

Descripción

A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00338286

Link

https://clinicaltrials.gov/show/NCT00338286

Palabras clave

Versiones (2)
  1. 12/1/17 12/1/17 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00338286

Inglés

Eligibility Breast Cancer NCT00338286

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed (e.g., slide of tissue) breast cancer
Descripción

Breast Carcinoma Slide Breast tissue sample

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1705201
UMLS CUI [1,3]
C0444070
her2/neu positive or negative
Descripción

HER2/Neu Positive | HER2/Neu Negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348909
UMLS CUI [2]
C2348908
clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (m1) lesion prior to starting the current chemotherapy
Descripción

Neoplasm Metastasis Evidence Biopsy | Measurable lesion metastatic Quantity | Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0392920
received 1st and 2nd line chemotherapy
Descripción

Chemotherapy First line treatment | Chemotherapy Second line treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1708063
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1710038
hemoglobin (hb) <= 11g/dl at the time of randomization
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
planned to receive at least 2 more cycles of chemotherapy
Descripción

Chemotherapy cycle Quantity Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1301732
life expectancy > 6 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group score 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
at least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year
Descripción

Age | Contraceptive methods | Female Sterilization | Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0232970
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
active second cancer
Descripción

Second Primary Cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751623
no recent history of clinically relevant thrombovascular event
Descripción

Thrombotic disorder Relevant Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
current treatment with anticoagulants
Descripción

Anticoagulants

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003280
brain metastasis or cns involvement
Descripción

Metastatic malignant neoplasm to brain | Central Nervous System Involvement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C4050309
anemia secondary to another cause
Descripción

Anemia Secondary to Cause

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
recent (within prior 1 months) use of an esa
Descripción

Erythropoiesis Stimulating Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1959590
patient pregnant or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
progressive disease during adjuvant/neoadjuvant chemotherapy
Descripción

Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | Progressive Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C1335499
rapidly progressive or life-threatening metastatic disease
Descripción

Neoplasm Metastasis Rapidly progressive | Neoplasm Metastasis Life Threatening

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1838681
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C2826244
concomitant endocrine therapy
Descripción

Hormone Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279025
patient in whom the only site of metastasis was local and was successfully treated surgically.
Descripción

Neoplasm Metastasis Site Local | Neoplasm Metastasis Operative Surgical Procedure Successful

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1272703
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Similar models

Eligibility Breast Cancer NCT00338286

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Slide Breast tissue sample
Item
histologically confirmed (e.g., slide of tissue) breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1705201 (UMLS CUI [1,2])
C0444070 (UMLS CUI [1,3])
HER2/Neu Positive | HER2/Neu Negative
Item
her2/neu positive or negative
boolean
C2348909 (UMLS CUI [1])
C2348908 (UMLS CUI [2])
Neoplasm Metastasis Evidence Biopsy | Measurable lesion metastatic Quantity | Chemotherapy
Item
clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (m1) lesion prior to starting the current chemotherapy
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
Chemotherapy First line treatment | Chemotherapy Second line treatment
Item
received 1st and 2nd line chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1710038 (UMLS CUI [2,2])
Hemoglobin measurement
Item
hemoglobin (hb) <= 11g/dl at the time of randomization
boolean
C0518015 (UMLS CUI [1])
Chemotherapy cycle Quantity Planned
Item
planned to receive at least 2 more cycles of chemotherapy
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group score 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age | Contraceptive methods | Female Sterilization | Postmenopausal state
Item
at least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year
boolean
C0001779 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Second Primary Cancer
Item
active second cancer
boolean
C0751623 (UMLS CUI [1])
Thrombotic disorder Relevant Clinical
Item
no recent history of clinically relevant thrombovascular event
boolean
C0040053 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Anticoagulants
Item
current treatment with anticoagulants
boolean
C0003280 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Central Nervous System Involvement
Item
brain metastasis or cns involvement
boolean
C0220650 (UMLS CUI [1])
C4050309 (UMLS CUI [2])
Anemia Secondary to Cause
Item
anemia secondary to another cause
boolean
C0002871 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Erythropoiesis Stimulating Agents
Item
recent (within prior 1 months) use of an esa
boolean
C1959590 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy, Adjuvant | Neoadjuvant Chemotherapy | Progressive Disease
Item
progressive disease during adjuvant/neoadjuvant chemotherapy
boolean
C0085533 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
Neoplasm Metastasis Rapidly progressive | Neoplasm Metastasis Life Threatening
Item
rapidly progressive or life-threatening metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C1838681 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
Hormone Therapy
Item
concomitant endocrine therapy
boolean
C0279025 (UMLS CUI [1])
Neoplasm Metastasis Site Local | Neoplasm Metastasis Operative Surgical Procedure Successful
Item
patient in whom the only site of metastasis was local and was successfully treated surgically.
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
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