ID

38321

Description

Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01262274

Link

https://clinicaltrials.gov/show/NCT01262274

Keywords

Versions (1)
  1. 10/10/19 10/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01262274

English

Eligibility Breast Neoplasms NCT01262274

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically-confirmed diagnosis of invasive breast cancer
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
clinical stage t2, n0 or n1, m0 (tnm classification)
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
patients must be postmenopausal
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
tumors are estrogen receptor (er) positive and human epidermal growth factor receptor (her2) negative
Description

Estrogen receptor positive tumor | Neoplasms HER2 Negative

Data type

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348908
ecog performance status (ps) 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must be able to swallow tablets and capsules
Description

Able to swallow Tablets | Able to swallow Capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0039225
UMLS CUI [2,1]
C2712086
UMLS CUI [2,2]
C0006935
candidates for mastectomy or breast-conserving surgery
Description

Patients Appropriate Mastectomy | Patients Appropriate Breast-Conserving Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0024881
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0917927
adequate bone marrow, liver and renal function
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
written informed consent was obtained from all patients before randomization.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inoperable, bilateral or inflammatory breast cancer
Description

Breast Carcinoma Inoperable | Bilateral breast cancer | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C0281267
UMLS CUI [3]
C0278601
multiple carcinoma
Description

Multiple malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0346429
personal history of invasive carcinoma
Description

Invasive Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1334274
patients receive systemic therapy of corticosteroid
Description

Systemic Corticosteroid Therapy

Data type

boolean

Alias
UMLS CUI [1]
C4053960
patients receive estrogen preparation or raloxifene
Description

Estrogens | Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0014939
UMLS CUI [2]
C0244404
patients with other concurrent severe and/or uncontrolled medical disease
Description

Comorbidity Severe | Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Description

Study Subject Participation Status Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205412
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Similar models

Eligibility Breast Neoplasms NCT01262274

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically-confirmed diagnosis of invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
TNM Breast tumor staging
Item
clinical stage t2, n0 or n1, m0 (tnm classification)
boolean
C0474926 (UMLS CUI [1])
Postmenopausal state
Item
patients must be postmenopausal
boolean
C0232970 (UMLS CUI [1])
Estrogen receptor positive tumor | Neoplasms HER2 Negative
Item
tumors are estrogen receptor (er) positive and human epidermal growth factor receptor (her2) negative
boolean
C1562312 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status (ps) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Able to swallow Tablets | Able to swallow Capsules
Item
patients must be able to swallow tablets and capsules
boolean
C2712086 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C2712086 (UMLS CUI [2,1])
C0006935 (UMLS CUI [2,2])
Patients Appropriate Mastectomy | Patients Appropriate Breast-Conserving Surgery
Item
candidates for mastectomy or breast-conserving surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0024881 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0917927 (UMLS CUI [2,3])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent
Item
written informed consent was obtained from all patients before randomization.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma Inoperable | Bilateral breast cancer | Inflammatory Breast Carcinoma
Item
inoperable, bilateral or inflammatory breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0281267 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
Multiple malignancy
Item
multiple carcinoma
boolean
C0346429 (UMLS CUI [1])
Invasive Carcinoma
Item
personal history of invasive carcinoma
boolean
C1334274 (UMLS CUI [1])
Systemic Corticosteroid Therapy
Item
patients receive systemic therapy of corticosteroid
boolean
C4053960 (UMLS CUI [1])
Estrogens | Raloxifene
Item
patients receive estrogen preparation or raloxifene
boolean
C0014939 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
Comorbidity Severe | Comorbidity Uncontrolled
Item
patients with other concurrent severe and/or uncontrolled medical disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Study Subject Participation Status Inadequate
Item
patients whom doctors judged inadequate to the enrollment of this study by other reasons.
boolean
C2348568 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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