ID

37900

Description

Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01186991

Link

https://clinicaltrials.gov/show/NCT01186991

Keywords

Versions (1)
  1. 8/29/19 8/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01186991

English

Eligibility Breast Cancer NCT01186991

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women age >/= 18 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
eastern cooperative oncology group (ecog) performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed er-, pr-, and her2-negative (triple-negative) adenocarcinoma of the breast
Description

Breast adenocarcinoma Estrogen receptor negative Progesterone receptor negative HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0279756
UMLS CUI [1,3]
C0279766
UMLS CUI [1,4]
C2348908
confirmed availability of tumor tissue
Description

Availability of Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior therapy with two or more regimens for metastatic breast cancer
Description

Prior Therapy Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
any systemic anti-cancer therapy within 3 weeks prior to day 1 of cycle 1
Description

Cancer treatment Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to day 1 of cycle 1
Description

Major surgery | Incisional biopsy | Traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
prior therapy with a taxane for metastatic breast cancer
Description

Prior Therapy Secondary malignant neoplasm of female breast | taxane

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0346993
UMLS CUI [2]
C0215136
prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vegf pathway-targeted therapy following diagnosis of breast cancer
Description

Prior Therapy | bevacizumab | sorafenib | sunitinib | VEGF Pathway Targeted Therapy | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0796392
UMLS CUI [3]
C1516119
UMLS CUI [4]
C1176020
UMLS CUI [5,1]
C2984329
UMLS CUI [5,2]
C2985566
UMLS CUI [6]
C0678222
prior therapy with hormones and/or trastuzumab
Description

Prior Hormone Therapy | trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C0728747
inadequate hematology, renal, or hepatic organ function
Description

Hematologic function Inadequate | Renal function Inadequate | Liver function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205412
bevacizumab exclusion criteria
Description

bevacizumab | Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2]
C0680251
uncontrolled hypertension (systolic pressure > 150 mmhg and/or diastolic pressure > 100 mmhg), with or without anti-hypertensive medication
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0003364
UMLS CUI [5,1]
C0003364
UMLS CUI [5,2]
C0332197
evidence of bleeding diathesis or coagulopathy
Description

Bleeding tendency | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
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Similar models

Eligibility Breast Cancer NCT01186991

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women age >/= 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Breast adenocarcinoma Estrogen receptor negative Progesterone receptor negative HER2 Negative
Item
histologically confirmed er-, pr-, and her2-negative (triple-negative) adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0279766 (UMLS CUI [1,3])
C2348908 (UMLS CUI [1,4])
Availability of Tumor tissue sample
Item
confirmed availability of tumor tissue
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Quantity Secondary malignant neoplasm of female breast
Item
prior therapy with two or more regimens for metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Cancer treatment Systemic
Item
any systemic anti-cancer therapy within 3 weeks prior to day 1 of cycle 1
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Major surgery | Incisional biopsy | Traumatic injury
Item
major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to day 1 of cycle 1
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Prior Therapy Secondary malignant neoplasm of female breast | taxane
Item
prior therapy with a taxane for metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2])
Prior Therapy | bevacizumab | sorafenib | sunitinib | VEGF Pathway Targeted Therapy | Breast Carcinoma
Item
prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vegf pathway-targeted therapy following diagnosis of breast cancer
boolean
C1514463 (UMLS CUI [1])
C0796392 (UMLS CUI [2])
C1516119 (UMLS CUI [3])
C1176020 (UMLS CUI [4])
C2984329 (UMLS CUI [5,1])
C2985566 (UMLS CUI [5,2])
C0678222 (UMLS CUI [6])
Prior Hormone Therapy | trastuzumab
Item
prior therapy with hormones and/or trastuzumab
boolean
C1514460 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Hematologic function Inadequate | Renal function Inadequate | Liver function Inadequate
Item
inadequate hematology, renal, or hepatic organ function
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
bevacizumab | Exclusion Criteria
Item
bevacizumab exclusion criteria
boolean
C0796392 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Antihypertensive Agents Absent
Item
uncontrolled hypertension (systolic pressure > 150 mmhg and/or diastolic pressure > 100 mmhg), with or without anti-hypertensive medication
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0003364 (UMLS CUI [4])
C0003364 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Bleeding tendency | Blood Coagulation Disorders
Item
evidence of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
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