ID

30609

Beschreibung

A Randomized Trial Comparing Epirubicin/Cyclophosphamide Followed by Weekly Paclitaxel Versus Epirubicin/Paclitaxel Followed by Weekly Paclitaxel as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old; ODM derived from: https://clinicaltrials.gov/show/NCT01026116

Link

https://clinicaltrials.gov/show/NCT01026116

Stichworte

Versionen (3)
  1. 17.06.18 17.06.18 -
  2. 18.06.18 18.06.18 - Julian Varghese
  3. 18.06.18 18.06.18 - Julian Varghese
Rechteinhaber

see clinicaltrials.gov

Hochgeladen am

18. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01026116

Englisch

Eligibility Breast Neoplasms NCT01026116

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, age 18~40
Beschreibung

Gender; Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
unilateral, operable, histologically confirmed adenocarcinoma of the breast
Beschreibung

Breast adenocarcinoma, Unilateral, Operable, histological diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0205188
UMLS CUI [1,4]
C0679557
stage i-iii
Beschreibung

Breast adenocarcinoma, TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C3258246
primary surgery with clear margins plus axillary dissection
Beschreibung

Operative Surgical Procedures, Negative Surgical Margin, Primary; Excision of axillary lymph nodes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1709157
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C0193867
able to start protocol rx within 4 weeks of surgery
Beschreibung

Data Management Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596404
UMLS CUI [1,2]
C0085732
her-2 positive (ihc 3+ or fish+) and sequential use of trastuzumab followed by chemotherapy
Beschreibung

HER2-positive carcinoma of breast, Fluorescent in situ hybridisation positive, Immunohistochemistry; trastuzumab, Application procedure, Sequential; Chemotherapy, Adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C3495875
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0185125
UMLS CUI [2,3]
C1705294
UMLS CUI [2,4]
C0085533
occult breast cancer with histologically confirmed primary invasive carcinoma or dics with microinvasion in the ipsilateral breast after surgery
Beschreibung

Breast Carcinoma, Occult; Invasive carcinoma of breast, Primary; Ductal Carcinoma In Situ with Microinvasion, Ipsilateral, Status post Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205262
UMLS CUI [1,3]
C0853879
UMLS CUI [1,4]
C0205225
UMLS CUI [2,1]
C2732473
UMLS CUI [2,2]
C0441989
UMLS CUI [2,3]
C0231290
UMLS CUI [2,4]
C0543467
ecog performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate cardiac, renal, hepatic and hematologic function
Beschreibung

Cardiac function; Renal function; Liver function; Hematologic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0221130
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
bilateral breast cancer (synchronous or metachronous)
Beschreibung

bilateral breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
Beschreibung

Therapeutic radiology procedure Breast Carcinoma Before; Hormone Therapy Breast Carcinoma Before; Chemotherapy Regimen Breast Carcinoma Before

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0332152
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C0332152
previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
Beschreibung

Malignant Neoplasms, Pre-existing condition; Basal cell carcinoma, Received therapy, Exception; Squamous cell carcinoma of skin, Received therapy, Exception; Malignant tumor of cervix, Exception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0521987
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C0332154
UMLS CUI [2,3]
C1705847
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C0332154
UMLS CUI [3,3]
C1705847
UMLS CUI [4,1]
C0007847
UMLS CUI [4,2]
C1705847
her-2 positive (ihc 3+ or fish+) and concurrence use of adjuvant chemotherapy and trastuzumab
Beschreibung

ER2-positive carcinoma of breast, Fluorescent in situ hybridisation positive, Immunohistochemistry; Chemotherapy, Adjuvant; trastuzumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C3495875
UMLS CUI [1,3]
C0021044
UMLS CUI [2]
C0085533
UMLS CUI [3]
C0728747
documented history of cardiac disease contradiction anthracyclines
Beschreibung

Anthracyclines, Heart Diseases, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0018799
UMLS CUI [1,3]
C0205156
concurrent serious illness
Beschreibung

Comorbidity, Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
peripheral neuropathy of ctc grade>1
Beschreibung

Peripheral Neuropathy, National Cancer Institute common terminology criteria for adverse events

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of hypersensitivity to drugs formulated in cremophor el polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
Beschreibung

Hypersensitivity cremophor EL

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0056476
pregnancy or lactation
Beschreibung

Pregnancy; Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Breast Neoplasms NCT01026116

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender; Age
Item
female patients, age 18~40
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma, Unilateral, Operable, histological diagnosis
Item
unilateral, operable, histologically confirmed adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
C0679557 (UMLS CUI [1,4])
Breast adenocarcinoma, TNM clinical staging
Item
stage i-iii
boolean
C0858252 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures, Negative Surgical Margin, Primary; Excision of axillary lymph nodes
Item
primary surgery with clear margins plus axillary dissection
boolean
C0543467 (UMLS CUI [1,1])
C1709157 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0193867 (UMLS CUI [2])
Data Management Ability
Item
able to start protocol rx within 4 weeks of surgery
boolean
C0596404 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
HER2-positive carcinoma of breast, Fluorescent in situ hybridisation positive, Immunohistochemistry; trastuzumab, Application procedure, Sequential; Chemotherapy, Adjuvant
Item
her-2 positive (ihc 3+ or fish+) and sequential use of trastuzumab followed by chemotherapy
boolean
C1960398 (UMLS CUI [1,1])
C3495875 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2,1])
C0185125 (UMLS CUI [2,2])
C1705294 (UMLS CUI [2,3])
C0085533 (UMLS CUI [2,4])
Breast Carcinoma, Occult; Invasive carcinoma of breast, Primary; Ductal Carcinoma In Situ with Microinvasion, Ipsilateral, Status post Operative Surgical Procedures
Item
occult breast cancer with histologically confirmed primary invasive carcinoma or dics with microinvasion in the ipsilateral breast after surgery
boolean
C0678222 (UMLS CUI [1,1])
C0205262 (UMLS CUI [1,2])
C0853879 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C2732473 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0231290 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Cardiac function; Renal function; Liver function; Hematologic function
Item
adequate cardiac, renal, hepatic and hematologic function
boolean
C0232164 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0221130 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
bilateral breast cancer
Item
bilateral breast cancer (synchronous or metachronous)
boolean
C0281267 (UMLS CUI [1])
Therapeutic radiology procedure Breast Carcinoma Before; Hormone Therapy Breast Carcinoma Before; Chemotherapy Regimen Breast Carcinoma Before
Item
prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Malignant Neoplasms, Pre-existing condition; Basal cell carcinoma, Received therapy, Exception; Squamous cell carcinoma of skin, Received therapy, Exception; Malignant tumor of cervix, Exception
Item
previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
boolean
C0006826 (UMLS CUI [1,1])
C0521987 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C0332154 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C0332154 (UMLS CUI [3,2])
C1705847 (UMLS CUI [3,3])
C0007847 (UMLS CUI [4,1])
C1705847 (UMLS CUI [4,2])
ER2-positive carcinoma of breast, Fluorescent in situ hybridisation positive, Immunohistochemistry; Chemotherapy, Adjuvant; trastuzumab
Item
her-2 positive (ihc 3+ or fish+) and concurrence use of adjuvant chemotherapy and trastuzumab
boolean
C1960398 (UMLS CUI [1,1])
C3495875 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2])
C0728747 (UMLS CUI [3])
Anthracyclines, Heart Diseases, Previous
Item
documented history of cardiac disease contradiction anthracyclines
boolean
C0282564 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Comorbidity, Serious
Item
concurrent serious illness
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Peripheral Neuropathy, National Cancer Institute common terminology criteria for adverse events
Item
peripheral neuropathy of ctc grade>1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity cremophor EL
Item
history of hypersensitivity to drugs formulated in cremophor el polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
boolean
C0020517 (UMLS CUI [1,1])
C0056476 (UMLS CUI [1,2])
Pregnancy; Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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