ID

16339

Beskrivning

Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00251329

Länk

https://clinicaltrials.gov/show/NCT00251329

Nyckelord

Versioner (1)
  1. 2016-07-11 2016-07-11 -
Uppladdad den

11 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00251329

Engelsk

Eligibility Breast Cancer NCT00251329

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women or men > 18 years old with histologically confirmed, by needle core biopsy (not fna), locally advanced or inflammatory breast cancer.
Beskrivning

Age | Locally advanced breast cancer | Inflammatory Breast Carcinoma | Core needle biopsy | Fine needle aspiration biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3495949
UMLS CUI [3]
C0278601
UMLS CUI [4]
C1318309
UMLS CUI [5]
C1510483
all patients must have either t2 lesion which is felt to be initially resectable only through mastectomy by the surgeon, or with a t3 n0-n2; t4 any n; or any t with n2 or n3 clinical evidence of disease. stage 2 patients where breast conservation surgery is desired but impractical at diagnosis because of anticipated poor cosmetic outcome are eligible. patients with inflammatory breast carcinoma and women with ipsilateral supraclavicular node involvement are eligible. patients must have measurable disease defined as a breast lesion > 2 cm or with fixed or marked ipsilateral axillary nodes and/or ipsilateral internal mammary nodes.
Beskrivning

TNM clinical staging | Mastectomy | Breast-Conserving Surgery | Inflammatory Breast Carcinoma | Lymph Node Involvement region supraclavicular Ipsilateral | Measurable Disease | Lesion of breast size | Axillary lymph nodes Ipsilateral Fixed | Axillary lymph nodes Ipsilateral Marked | Internal mammary lymph nodes Ipsilateral

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0917927
UMLS CUI [4]
C0278601
UMLS CUI [5,1]
C0806692
UMLS CUI [5,2]
C0446461
UMLS CUI [5,3]
C0441989
UMLS CUI [6]
C1513041
UMLS CUI [7,1]
C0567489
UMLS CUI [7,2]
C0456389
UMLS CUI [8,1]
C0729594
UMLS CUI [8,2]
C0441989
UMLS CUI [8,3]
C3714578
UMLS CUI [9,1]
C0729594
UMLS CUI [9,2]
C0441989
UMLS CUI [9,3]
C1706089
UMLS CUI [10,1]
C0542554
UMLS CUI [10,2]
C0441989
pre-and post-menopausal female and male patients are eligible. women of childbearing potential must have a negative pregnancy test and, men and women must be willing to consent to using effective dual methods of contraception while on treatment and for three months thereafter.
Beskrivning

Premenopausal state | Postmenopausal state | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception Willing | Gender Oral Hormonal Contraceptives Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0004764
UMLS CUI [4,3]
C0600109
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0009907
UMLS CUI [5,3]
C0600109
life expectancy of greater than 6 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
bone scan and cat scan of chest and abdomen negative for metastatic disease
Beskrivning

Bone scan Chest Metastatic Neoplasm Negative | Bone scan Abdomen Metastatic Neoplasm Negative | Chest CT Metastatic Neoplasm Negative | CT Abdomen Metastatic Neoplasm Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C2939420
UMLS CUI [1,4]
C0205160
UMLS CUI [2,1]
C0203668
UMLS CUI [2,2]
C0000726
UMLS CUI [2,3]
C2939420
UMLS CUI [2,4]
C0205160
UMLS CUI [3,1]
C0202823
UMLS CUI [3,2]
C2939420
UMLS CUI [3,3]
C0205160
UMLS CUI [4,1]
C0040405
UMLS CUI [4,2]
C0000726
UMLS CUI [4,3]
C2939420
UMLS CUI [4,4]
C0205160
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with metastatic disease.
Beskrivning

Metastatic Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C2939420
patients may not be receiving any other investigational agents.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection other than mild resolving cellulitis, symptomatic congestive heart failure (nyha > class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Beskrivning

Intercurrent disease Uncontrolled | Communicable Disease | Communicable Disease Continuous | Cellulitis Resolving Mild | Congestive heart failure Symptomatic | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Coronary Artery Disease | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0549178
UMLS CUI [4,1]
C0007642
UMLS CUI [4,2]
C3714811
UMLS CUI [4,3]
C2945599
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0231220
UMLS CUI [6]
C0002965
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205318
UMLS CUI [8]
C1956346
UMLS CUI [9,1]
C0004936
UMLS CUI [9,2]
C1321605
UMLS CUI [9,3]
C0439801
UMLS CUI [10,1]
C0748872
UMLS CUI [10,2]
C1321605
UMLS CUI [10,3]
C0439801
cancer other than breast primary within the last 5 years with the exception of surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.
Beskrivning

Malignant Neoplasms | malignant neoplasm of breast TNM staging primary tumor | Skin carcinoma cured disease Surgical | Carcinoma in situ of uterine cervix cured disease Surgical

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C2216708
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C0679252
UMLS CUI [3,3]
C0543467
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C0679252
UMLS CUI [4,3]
C0543467
women who are breast-feeding.
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer NCT00251329

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Locally advanced breast cancer | Inflammatory Breast Carcinoma | Core needle biopsy | Fine needle aspiration biopsy
Item
women or men > 18 years old with histologically confirmed, by needle core biopsy (not fna), locally advanced or inflammatory breast cancer.
boolean
C0001779 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
C1318309 (UMLS CUI [4])
C1510483 (UMLS CUI [5])
TNM clinical staging | Mastectomy | Breast-Conserving Surgery | Inflammatory Breast Carcinoma | Lymph Node Involvement region supraclavicular Ipsilateral | Measurable Disease | Lesion of breast size | Axillary lymph nodes Ipsilateral Fixed | Axillary lymph nodes Ipsilateral Marked | Internal mammary lymph nodes Ipsilateral
Item
all patients must have either t2 lesion which is felt to be initially resectable only through mastectomy by the surgeon, or with a t3 n0-n2; t4 any n; or any t with n2 or n3 clinical evidence of disease. stage 2 patients where breast conservation surgery is desired but impractical at diagnosis because of anticipated poor cosmetic outcome are eligible. patients with inflammatory breast carcinoma and women with ipsilateral supraclavicular node involvement are eligible. patients must have measurable disease defined as a breast lesion > 2 cm or with fixed or marked ipsilateral axillary nodes and/or ipsilateral internal mammary nodes.
boolean
C3258246 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0917927 (UMLS CUI [3])
C0278601 (UMLS CUI [4])
C0806692 (UMLS CUI [5,1])
C0446461 (UMLS CUI [5,2])
C0441989 (UMLS CUI [5,3])
C1513041 (UMLS CUI [6])
C0567489 (UMLS CUI [7,1])
C0456389 (UMLS CUI [7,2])
C0729594 (UMLS CUI [8,1])
C0441989 (UMLS CUI [8,2])
C3714578 (UMLS CUI [8,3])
C0729594 (UMLS CUI [9,1])
C0441989 (UMLS CUI [9,2])
C1706089 (UMLS CUI [9,3])
C0542554 (UMLS CUI [10,1])
C0441989 (UMLS CUI [10,2])
Premenopausal state | Postmenopausal state | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception Willing | Gender Oral Hormonal Contraceptives Willing
Item
pre-and post-menopausal female and male patients are eligible. women of childbearing potential must have a negative pregnancy test and, men and women must be willing to consent to using effective dual methods of contraception while on treatment and for three months thereafter.
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0009907 (UMLS CUI [5,2])
C0600109 (UMLS CUI [5,3])
Life Expectancy
Item
life expectancy of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Bone scan Chest Metastatic Neoplasm Negative | Bone scan Abdomen Metastatic Neoplasm Negative | Chest CT Metastatic Neoplasm Negative | CT Abdomen Metastatic Neoplasm Negative
Item
bone scan and cat scan of chest and abdomen negative for metastatic disease
boolean
C0203668 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C2939420 (UMLS CUI [1,3])
C0205160 (UMLS CUI [1,4])
C0203668 (UMLS CUI [2,1])
C0000726 (UMLS CUI [2,2])
C2939420 (UMLS CUI [2,3])
C0205160 (UMLS CUI [2,4])
C0202823 (UMLS CUI [3,1])
C2939420 (UMLS CUI [3,2])
C0205160 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4,1])
C0000726 (UMLS CUI [4,2])
C2939420 (UMLS CUI [4,3])
C0205160 (UMLS CUI [4,4])
Item Group
C0680251 (UMLS CUI)
Metastatic Neoplasm
Item
patients with metastatic disease.
boolean
C2939420 (UMLS CUI [1])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Intercurrent disease Uncontrolled | Communicable Disease | Communicable Disease Continuous | Cellulitis Resolving Mild | Congestive heart failure Symptomatic | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Coronary Artery Disease | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection other than mild resolving cellulitis, symptomatic congestive heart failure (nyha > class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0277557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C0007642 (UMLS CUI [4,1])
C3714811 (UMLS CUI [4,2])
C2945599 (UMLS CUI [4,3])
C0018802 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C1956346 (UMLS CUI [8])
C0004936 (UMLS CUI [9,1])
C1321605 (UMLS CUI [9,2])
C0439801 (UMLS CUI [9,3])
C0748872 (UMLS CUI [10,1])
C1321605 (UMLS CUI [10,2])
C0439801 (UMLS CUI [10,3])
Malignant Neoplasms | malignant neoplasm of breast TNM staging primary tumor | Skin carcinoma cured disease Surgical | Carcinoma in situ of uterine cervix cured disease Surgical
Item
cancer other than breast primary within the last 5 years with the exception of surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C2216708 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C0679252 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C0679252 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
Breast Feeding
Item
women who are breast-feeding.
boolean
C0006147 (UMLS CUI [1])
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