ID

29845

Beschreibung

Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00615524

Link

https://clinicaltrials.gov/show/NCT00615524

Stichworte

Versionen (1)
  1. 24.04.18 24.04.18 -
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See clinicaltrials.gov

Hochgeladen am

24. April 2018

DOI

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Eligibility Hormone-receptor Positive Breast Cancer NCT00615524

Englisch

Eligibility Hormone-receptor Positive Breast Cancer NCT00615524

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have measurable disease or must be evaluable for disease progression
Beschreibung

Measurable Disease | Evaluable Patient Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C2986511
UMLS CUI [2,2]
C0242656
age >/= 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
postmenopausal women
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
eastern cooperative oncology group (ecog) performance status (ps) 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically confirmed er and/or pgr positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
Beschreibung

Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Disease unresectable | Disease Advanced Locally | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C2938924
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205179
UMLS CUI [4,3]
C1517927
UMLS CUI [5]
C0027627
subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
Beschreibung

Prior Hormone Therapy Breast Carcinoma | anastrozole | letrozole | Tamoxifen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0290883
UMLS CUI [3]
C0246421
UMLS CUI [4]
C0039286
adequate hematologic, hepatic, and renal function
Beschreibung

Hematologic function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of exemestane or pazopanib
Beschreibung

exemestane | pazopanib

Datentyp

boolean

Alias
UMLS CUI [1]
C0851344
UMLS CUI [2]
C1831796
premenopausal women
Beschreibung

Premenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232969
any ongoing toxicity from prior anti-cancer therapy that is >grade 1 and/or that is progressing in severity.
Beschreibung

Cancer treatment | Toxicity CTCAE Grades | Toxicity Severitiy Progressing

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0439793
UMLS CUI [3,3]
C0205329
prior therapy with a vegf inhibitor.
Beschreibung

Vascular Endothelial Growth Factor Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2267120
use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
Beschreibung

Investigational New Drugs | Antineoplastic Agents Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1517586
evidence of recurrence or active disease from prior malignancy.
Beschreibung

Recurrent disease | Disease Due to Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0006826
clinically significant gastrointestinal abnormalities that may increase the risk for gi bleeding or affect the absorption of the investigational product(s).
Beschreibung

Abnormality of the gastrointestinal tract At risk Gastrointestinal Hemorrhage | Abnormality of the gastrointestinal tract Affecting Absorption Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4023588
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0017181
UMLS CUI [2,1]
C4023588
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
presence of uncontrolled infection.
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
history of any major cardiovascular conditions within the past 6 months:
Beschreibung

Cardiovascular Disease Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205164
poorly controlled hypertension
Beschreibung

Hypertensive disease Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C3853134
history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months.
Beschreibung

Cerebrovascular accident | Pulmonary Embolism | Deep Vein Thrombosis untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0034065
UMLS CUI [3,1]
C0149871
UMLS CUI [3,2]
C0332155
prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
Beschreibung

Major surgery | Trauma | Wound, non-healed | Fracture | Ulcer

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3714660
UMLS CUI [3]
C0750433
UMLS CUI [4]
C0016658
UMLS CUI [5]
C0041582
evidence of active bleeding or bleeding tendency.
Beschreibung

Hemorrhage | Bleeding tendency

Datentyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
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Ähnliche Modelle

Eligibility Hormone-receptor Positive Breast Cancer NCT00615524

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Measurable Disease | Evaluable Patient Disease Progression
Item
subjects must have measurable disease or must be evaluable for disease progression
boolean
C1513041 (UMLS CUI [1])
C2986511 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Age
Item
age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Disease unresectable | Disease Advanced Locally | Neoplasm Metastasis
Item
histologically or cytologically confirmed er and/or pgr positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
boolean
C2938924 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5])
Prior Hormone Therapy Breast Carcinoma | anastrozole | letrozole | Tamoxifen
Item
subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
boolean
C1514460 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0290883 (UMLS CUI [2])
C0246421 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
exemestane | pazopanib
Item
prior use of exemestane or pazopanib
boolean
C0851344 (UMLS CUI [1])
C1831796 (UMLS CUI [2])
Premenopausal state
Item
premenopausal women
boolean
C0232969 (UMLS CUI [1])
Cancer treatment | Toxicity CTCAE Grades | Toxicity Severitiy Progressing
Item
any ongoing toxicity from prior anti-cancer therapy that is >grade 1 and/or that is progressing in severity.
boolean
C0920425 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C0439793 (UMLS CUI [3,2])
C0205329 (UMLS CUI [3,3])
Vascular Endothelial Growth Factor Inhibitors
Item
prior therapy with a vegf inhibitor.
boolean
C2267120 (UMLS CUI [1])
Investigational New Drugs | Antineoplastic Agents Investigational
Item
use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
boolean
C0013230 (UMLS CUI [1])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Recurrent disease | Disease Due to Malignant Neoplasms
Item
evidence of recurrence or active disease from prior malignancy.
boolean
C0277556 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Abnormality of the gastrointestinal tract At risk Gastrointestinal Hemorrhage | Abnormality of the gastrointestinal tract Affecting Absorption Investigational New Drugs
Item
clinically significant gastrointestinal abnormalities that may increase the risk for gi bleeding or affect the absorption of the investigational product(s).
boolean
C4023588 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0017181 (UMLS CUI [1,3])
C4023588 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Communicable Disease Uncontrolled
Item
presence of uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cardiovascular Disease Major
Item
history of any major cardiovascular conditions within the past 6 months:
boolean
C0007222 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Hypertensive disease Poorly controlled
Item
poorly controlled hypertension
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Cerebrovascular accident | Pulmonary Embolism | Deep Vein Thrombosis untreated
Item
history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months.
boolean
C0038454 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0149871 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Major surgery | Trauma | Wound, non-healed | Fracture | Ulcer
Item
prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
boolean
C0679637 (UMLS CUI [1])
C3714660 (UMLS CUI [2])
C0750433 (UMLS CUI [3])
C0016658 (UMLS CUI [4])
C0041582 (UMLS CUI [5])
Hemorrhage | Bleeding tendency
Item
evidence of active bleeding or bleeding tendency.
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
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