ID

26207

Beschrijving

Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00656669

Link

https://clinicaltrials.gov/show/NCT00656669

Trefwoorden

Versies (1)
  1. 11-10-17 11-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00656669

Engels

Eligibility Breast Cancer NCT00656669

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), ii or iii disease.
Beschrijving

Breast adenocarcinoma | Disease Operable TNM Breast tumor staging | Disease Inoperable TNM Breast tumor staging | Primary tumor Size

Datatype

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205188
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205187
UMLS CUI [3,3]
C0474926
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C0456389
2. measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or mr).
Beschrijving

Measurable Disease Physical Examination | Measurable Disease Breast imaging | Mammography | Ultrasonography | MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1134632
UMLS CUI [3]
C0024671
UMLS CUI [4]
C0041618
UMLS CUI [5]
C0024485
3. pre-treatment core or incisional biopsy. patients may not have had definitive primary surgery.
Beschrijving

Core biopsy pre treatment | Incisional biopsy pre treatment | Operative Surgical Procedure Primary Definitive Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C2709094
UMLS CUI [2,1]
C0184922
UMLS CUI [2,2]
C2709094
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0205225
UMLS CUI [3,3]
C0443196
UMLS CUI [3,4]
C0332197
4. male or female, 18 years of age or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. ecog performance status 0 or 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate organ function as defined in the protocol.
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.
Beschrijving

Therapeutic radiology procedure Breast Carcinoma | Cytotoxic therapy Breast Carcinoma | Systemic therapy Breast Carcinoma | Tamoxifen Chemoprevention allowed | Tamoxifen To be stopped | Raloxifene Chemoprevention allowed | Raloxifene To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0677881
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0039286
UMLS CUI [4,2]
C0282515
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0039286
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C0244404
UMLS CUI [6,2]
C0282515
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0244404
UMLS CUI [7,2]
C1272691
2. metastatic (stage iv) breast cancer
Beschrijving

Breast Carcinoma metastatic TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C0474926
3. patients who have had only a pre-treatment fine needle aspiration (fna) are excluded.
Beschrijving

Fine needle aspiration pre treatment only

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510483
UMLS CUI [1,2]
C2709094
UMLS CUI [1,3]
C0205171
4. current therapeutic treatment on another clinical trial with an investigational agent.
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
5. any of the following within the 6 months prior to starting study treatment:-myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus
Beschrijving

Myocardial Infarction | Angina, Unstable | Angina Pectoris Severe | Coronary Artery Bypass Surgery | Peripheral artery bypass | Congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0010055
UMLS CUI [5]
C3495795
UMLS CUI [6]
C0018802
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007787
UMLS CUI [9]
C0034065
6. ongoing cardiac dysrhythmias of nci ctcae grade >=2, atrial fibrillation of any grade, or qtc interval >450 msec for males or >470 msec for females.
Beschrijving

Cardiac Arrhythmia CTCAE Grades | Atrial Fibrillation Grade Any | QTc interval | Gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C1552551
UMLS CUI [3]
C0489625
UMLS CUI [4]
C0079399
7. hypertension that cannot be controlled by medications.
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
8. current treatment with therapeutic doses of any anti-coagulant. prophylactic use of anticoagulants is allowed.
Beschrijving

Anticoagulants Dose Therapeutic | Anticoagulants Prophylactic allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0302350
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C0199176
UMLS CUI [2,3]
C0683607
9. known human immunodeficiency virus (hiv) infection.
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
10. pregnancy or breastfeeding. all female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
11. other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Beschrijving

Medical condition Severe Study Subject Participation Status High risk | Medical condition Severe Investigational New Drugs High risk | Medical condition Severe Study Subject Participation Status Inappropriate | Chronic disease | Mental disorders Severe | Chronic mental disorder | Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0332167
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C0332167
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2348568
UMLS CUI [3,4]
C1548788
UMLS CUI [4]
C0008679
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0870281
UMLS CUI [7]
C0438215
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Similar models

Eligibility Breast Cancer NCT00656669

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | Disease Operable TNM Breast tumor staging | Disease Inoperable TNM Breast tumor staging | Primary tumor Size
Item
1. patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), ii or iii disease.
boolean
C0858252 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205187 (UMLS CUI [3,2])
C0474926 (UMLS CUI [3,3])
C0677930 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
Measurable Disease Physical Examination | Measurable Disease Breast imaging | Mammography | Ultrasonography | MRI
Item
2. measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or mr).
boolean
C1513041 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1134632 (UMLS CUI [2,2])
C0024671 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Core biopsy pre treatment | Incisional biopsy pre treatment | Operative Surgical Procedure Primary Definitive Absent
Item
3. pre-treatment core or incisional biopsy. patients may not have had definitive primary surgery.
boolean
C1318309 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0184922 (UMLS CUI [2,1])
C2709094 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C0443196 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Age
Item
4. male or female, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
6. adequate organ function as defined in the protocol.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Breast Carcinoma | Cytotoxic therapy Breast Carcinoma | Systemic therapy Breast Carcinoma | Tamoxifen Chemoprevention allowed | Tamoxifen To be stopped | Raloxifene Chemoprevention allowed | Raloxifene To be stopped
Item
1. prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0677881 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4,1])
C0282515 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0039286 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C0244404 (UMLS CUI [6,1])
C0282515 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0244404 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
Breast Carcinoma metastatic TNM Breast tumor staging
Item
2. metastatic (stage iv) breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Fine needle aspiration pre treatment only
Item
3. patients who have had only a pre-treatment fine needle aspiration (fna) are excluded.
boolean
C1510483 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
4. current therapeutic treatment on another clinical trial with an investigational agent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Angina Pectoris Severe | Coronary Artery Bypass Surgery | Peripheral artery bypass | Congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
5. any of the following within the 6 months prior to starting study treatment:-myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0010055 (UMLS CUI [4])
C3495795 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
Cardiac Arrhythmia CTCAE Grades | Atrial Fibrillation Grade Any | QTc interval | Gender
Item
6. ongoing cardiac dysrhythmias of nci ctcae grade >=2, atrial fibrillation of any grade, or qtc interval >450 msec for males or >470 msec for females.
boolean
C0003811 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0489625 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Uncontrolled hypertension
Item
7. hypertension that cannot be controlled by medications.
boolean
C1868885 (UMLS CUI [1])
Anticoagulants Dose Therapeutic | Anticoagulants Prophylactic allowed
Item
8. current treatment with therapeutic doses of any anti-coagulant. prophylactic use of anticoagulants is allowed.
boolean
C0003280 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
HIV Infection
Item
9. known human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative
Item
10. pregnancy or breastfeeding. all female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Medical condition Severe Study Subject Participation Status High risk | Medical condition Severe Investigational New Drugs High risk | Medical condition Severe Study Subject Participation Status Inappropriate | Chronic disease | Mental disorders Severe | Chronic mental disorder | Laboratory test result abnormal
Item
11. other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0332167 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0332167 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])
C0008679 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0870281 (UMLS CUI [6])
C0438215 (UMLS CUI [7])
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