ID

26016

Description

Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00428922

Link

https://clinicaltrials.gov/show/NCT00428922

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00428922

English

Eligibility Breast Cancer NCT00428922

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed breast cancer with evidence of metastatic disease
Description

Breast Carcinoma | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0027627
her2 3+ or fish +
Description

HER2 Gene Expression High | HER2 FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0205250
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C0162789
UMLS CUI [2,3]
C1446409
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
Description

Trastuzumab Absent | Exception Adjuvant therapy | Exception Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0600558
no prior chemotherapy in the metastatic setting.
Description

Chemotherapy Absent Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027627
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cns metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
prior radiation therapy within the last 4 weeks
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
pregnant (positive pregnancy test) or lactating women
Description

Pregnancy | Pregnancy test positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study
Description

Major surgery | Incisional biopsy | Non healing wound | Traumatic injury | Major surgery Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C0750433
UMLS CUI [4]
C3263723
UMLS CUI [5,1]
C0679637
UMLS CUI [5,2]
C0686904
minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.
Description

Minor Surgical Procedures | Fine needle aspiration | Core biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0038904
UMLS CUI [2]
C1510483
UMLS CUI [3]
C1318309
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Similar models

Eligibility Breast Cancer NCT00428922

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Neoplasm Metastasis
Item
histologically confirmed breast cancer with evidence of metastatic disease
boolean
C0678222 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
HER2 Gene Expression High | HER2 FISH Positive
Item
her2 3+ or fish +
boolean
C0069515 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C0069515 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Trastuzumab Absent | Exception Adjuvant therapy | Exception Neoadjuvant Therapy
Item
no prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
boolean
C0728747 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Chemotherapy Absent Neoplasm Metastasis
Item
no prior chemotherapy in the metastatic setting.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
cns metastases
boolean
C0686377 (UMLS CUI [1])
Therapeutic radiology procedure
Item
prior radiation therapy within the last 4 weeks
boolean
C1522449 (UMLS CUI [1])
Pregnancy | Pregnancy test positive | Breast Feeding
Item
pregnant (positive pregnancy test) or lactating women
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Major surgery | Incisional biopsy | Non healing wound | Traumatic injury | Major surgery Patient need for
Item
major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C0750433 (UMLS CUI [3])
C3263723 (UMLS CUI [4])
C0679637 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
Minor Surgical Procedures | Fine needle aspiration | Core biopsy
Item
minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.
boolean
C0038904 (UMLS CUI [1])
C1510483 (UMLS CUI [2])
C1318309 (UMLS CUI [3])
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