ID

37922

Beskrivning

Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01229605

Länk

https://clinicaltrials.gov/show/NCT01229605

Nyckelord

Versioner (1)
  1. 2019-08-30 2019-08-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01229605

Engelsk

Eligibility Breast Cancer NCT01229605

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18 years of age or older
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically documented adenocarcinoma of the breast, with t2 (t>2.0 cm) n0 or more advanced disease.
Beskrivning

Breast adenocarcinoma TNM Breast tumor staging | Advanced disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0679246
no evidence of metastatic disease.
Beskrivning

Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
disease must be clinically or radio-graphically measurable or evaluable.
Beskrivning

Measurable Disease Clinical | Measurable Disease Radiography | Evaluable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0043299
UMLS CUI [3]
C1516986
incisional or core needle biopsy, yielding sufficient tissue for histologic confirmation of adenocarcinoma, hormone receptor analysis and her2 testing; and tiam-1 expression.
Beskrivning

Incisional biopsy Providing Tissue specimen | Core needle biopsy Providing Tissue specimen | Adenocarcinoma Histology | Hormone Receptor Analysis | HER2 Testing | TIAM1 Expression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184922
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C1292533
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C1999230
UMLS CUI [2,3]
C1292533
UMLS CUI [3,1]
C0001418
UMLS CUI [3,2]
C0344441
UMLS CUI [4,1]
C0019929
UMLS CUI [4,2]
C0936012
UMLS CUI [5,1]
C0069515
UMLS CUI [5,2]
C0039593
UMLS CUI [6,1]
C0812248
UMLS CUI [6,2]
C0017262
subjects may have received no prior chemotherapy for breast cancer. subjects may have received up to 3 months of neoadjuvant hormonal therapy, provided they have been re-staged and are still eligible for this study, and have been off hormonal therapy at least 48 hours.
Beskrivning

Prior Chemotherapy Absent Breast Carcinoma | Neoadjuvant Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0279025
subject must be her-2 negative.
Beskrivning

Study Subject HER2 Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2348908
performance status 0-1 by the ecog scale.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
baseline laboratory values must be as follows: absolute granulocyte count: greater than 1400/cells/ml; platelets: greater than 100,000 cells/ml; total bilirubin: less than 1.5 mg/dl; serum alt: less than 2.5 x institutional upper normal limit; creatinine: less than 1.6mg/dl; hemoglobin: greater than 9.0g/dl
Beskrivning

Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0518015
subjects must be nonpregnant and nonlactating. subjects of childbearing potential must utilize an effective method of contraception during the study.
Beskrivning

Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone therapy for this cancer.
Beskrivning

Chemotherapy Malignant Neoplasms | Neoadjuvant Hormone Therapy Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C0006826
subjects with metastatic disease (disease beyond the breast, axillary nodes and ipsilateral supraclavicular nodes) or inflammatory breast cancer (t4d).
Beskrivning

Neoplasm Metastasis Except Breast | Neoplasm Metastasis Except Axillary lymph nodes | Neoplasm Metastasis Except Supraclavicular lymph nodes Ipsilateral | Inflammatory Breast Carcinoma TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0006141
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0729594
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0229730
UMLS CUI [3,4]
C0441989
UMLS CUI [4,1]
C0278601
UMLS CUI [4,2]
C0474926
subjects with other active cancers, except non-melanoma skin cancers
Beskrivning

Cancer Other | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
Beskrivning

Communicable Disease Serious Impairing Investigational Therapy | Medical condition Serious Impairing Investigational Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0949266
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0221099
UMLS CUI [2,4]
C0949266
dementia or significantly altered mental status that would prohibit comprehension of or giving of informed consent.
Beskrivning

Dementia Preventing Comprehension Informed Consent | Mental state altered Preventing Comprehension Informed Consent | Dementia Preventing Informed Consent | Mental state altered Preventing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0162340
UMLS CUI [2,5]
C0021430
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0278060
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C0021430
pregnant or breast-feeding women; sexually active, pre-menopausal women not willing to use adequate methods of birth control.
Beskrivning

Pregnancy | Breast Feeding | Gender Sexually active | Premenopausal state | Gender Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [4]
C0232969
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0558080
subjects who are her 2 neu positive are excluded.
Beskrivning

Study Subject HER2 Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2348909
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Similar models

Eligibility Breast Cancer NCT01229605

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma TNM Breast tumor staging | Advanced disease
Item
histologically documented adenocarcinoma of the breast, with t2 (t>2.0 cm) n0 or more advanced disease.
boolean
C0858252 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0679246 (UMLS CUI [2])
Neoplasm Metastasis Absent
Item
no evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease Clinical | Measurable Disease Radiography | Evaluable Disease
Item
disease must be clinically or radio-graphically measurable or evaluable.
boolean
C1513041 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C1516986 (UMLS CUI [3])
Incisional biopsy Providing Tissue specimen | Core needle biopsy Providing Tissue specimen | Adenocarcinoma Histology | Hormone Receptor Analysis | HER2 Testing | TIAM1 Expression
Item
incisional or core needle biopsy, yielding sufficient tissue for histologic confirmation of adenocarcinoma, hormone receptor analysis and her2 testing; and tiam-1 expression.
boolean
C0184922 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C1292533 (UMLS CUI [1,3])
C1318309 (UMLS CUI [2,1])
C1999230 (UMLS CUI [2,2])
C1292533 (UMLS CUI [2,3])
C0001418 (UMLS CUI [3,1])
C0344441 (UMLS CUI [3,2])
C0019929 (UMLS CUI [4,1])
C0936012 (UMLS CUI [4,2])
C0069515 (UMLS CUI [5,1])
C0039593 (UMLS CUI [5,2])
C0812248 (UMLS CUI [6,1])
C0017262 (UMLS CUI [6,2])
Prior Chemotherapy Absent Breast Carcinoma | Neoadjuvant Hormone Therapy
Item
subjects may have received no prior chemotherapy for breast cancer. subjects may have received up to 3 months of neoadjuvant hormonal therapy, provided they have been re-staged and are still eligible for this study, and have been off hormonal therapy at least 48 hours.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Study Subject HER2 Negative
Item
subject must be her-2 negative.
boolean
C0681850 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
ECOG performance status
Item
performance status 0-1 by the ecog scale.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Hemoglobin measurement
Item
baseline laboratory values must be as follows: absolute granulocyte count: greater than 1400/cells/ml; platelets: greater than 100,000 cells/ml; total bilirubin: less than 1.5 mg/dl; serum alt: less than 2.5 x institutional upper normal limit; creatinine: less than 1.6mg/dl; hemoglobin: greater than 9.0g/dl
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods
Item
subjects must be nonpregnant and nonlactating. subjects of childbearing potential must utilize an effective method of contraception during the study.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Malignant Neoplasms | Neoadjuvant Hormone Therapy Malignant Neoplasms
Item
subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone therapy for this cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Neoplasm Metastasis Except Breast | Neoplasm Metastasis Except Axillary lymph nodes | Neoplasm Metastasis Except Supraclavicular lymph nodes Ipsilateral | Inflammatory Breast Carcinoma TNM Breast tumor staging
Item
subjects with metastatic disease (disease beyond the breast, axillary nodes and ipsilateral supraclavicular nodes) or inflammatory breast cancer (t4d).
boolean
C0027627 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0729594 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0229730 (UMLS CUI [3,3])
C0441989 (UMLS CUI [3,4])
C0278601 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
Cancer Other | Exception Skin carcinoma
Item
subjects with other active cancers, except non-melanoma skin cancers
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Communicable Disease Serious Impairing Investigational Therapy | Medical condition Serious Impairing Investigational Therapy
Item
subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0949266 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0949266 (UMLS CUI [2,4])
Dementia Preventing Comprehension Informed Consent | Mental state altered Preventing Comprehension Informed Consent | Dementia Preventing Informed Consent | Mental state altered Preventing Informed Consent
Item
dementia or significantly altered mental status that would prohibit comprehension of or giving of informed consent.
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0278060 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0162340 (UMLS CUI [2,4])
C0021430 (UMLS CUI [2,5])
C0497327 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0278060 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C0021430 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Gender Sexually active | Premenopausal state | Gender Contraceptive methods Unwilling
Item
pregnant or breast-feeding women; sexually active, pre-menopausal women not willing to use adequate methods of birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0232969 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
Study Subject HER2 Positive
Item
subjects who are her 2 neu positive are excluded.
boolean
C0681850 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
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