ID

26668

Description

Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00876395

Link

https://clinicaltrials.gov/show/NCT00876395

Keywords

Versions (1)
  1. 10/23/17 10/23/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00876395

English

Eligibility Breast Cancer NCT00876395

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult women (≥ 18 years old).
Description

Adult | Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
Description

Invasive carcinoma of breast | Recurrent disease Local | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0027627
must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
Description

Measurable lesion Quantity | Bone lesion Without Measurable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C1513041
her2+ patients by local laboratory testing (ihc 3+ staining or in situ hybridization positive).
Description

HER2/Neu Positive Laboratory Procedures | Immunohistochemistry Positive Staining | In Situ Hybridization Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0487602
UMLS CUI [3,1]
C0162788
UMLS CUI [3,2]
C1514241
prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
Description

Trastuzumab To be stopped | Taxane To be stopped | Neoadjuvant Chemotherapy To be stopped | Adjuvant Chemotherapy To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C1272691
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C1272691
prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Description

Breast Carcinoma Therapeutic procedure To be stopped | Prior adjuvant endocrine therapy To be stopped | Neoplasm Metastasis Hormone Therapy To be stopped | Diphosphonates allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1272691
UMLS CUI [2,1]
C0281266
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0279025
UMLS CUI [3,3]
C1272691
UMLS CUI [4,1]
C0012544
UMLS CUI [4,2]
C0683607
documentation of negative pregnancy test.
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior mtor inhibitors for the treatment of cancer.
Description

mTOR Inhibitors Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1515672
UMLS CUI [1,2]
C0920425
other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
Description

Cancer treatment Locally advanced breast cancer | Cancer treatment Secondary malignant neoplasm of female breast | Exception Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C3495949
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0346993
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
Description

Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0205171
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0153690
radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
Description

Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
history of central nervous system metastasis.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
impairment of gastrointestinal (gi) function or gi disease or active ulceration of the upper gastrointestinal tract.
Description

Abnormal digestive tract function | Gastrointestinal Diseases | Ulceration Upper gastrointestinal tract

Data type

boolean

Alias
UMLS CUI [1]
C0232459
UMLS CUI [2]
C0017178
UMLS CUI [3,1]
C3887532
UMLS CUI [3,2]
C1268997
serious peripheral neuropathy.
Description

Peripheral Neuropathy Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0205404
cardiac disease or dysfunction.
Description

Heart Diseases | Cardiac dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C3277906
uncontrolled hypertension.
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
hiv.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
pregnant, other protocol-defined inclusion/exclusion criteria may apply
Description

Pregnancy | Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT00876395

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age
Item
adult women (≥ 18 years old).
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Invasive carcinoma of breast | Recurrent disease Local | Neoplasm Metastasis
Item
histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
boolean
C0853879 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
Measurable lesion Quantity | Bone lesion Without Measurable Disease
Item
must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
HER2/Neu Positive Laboratory Procedures | Immunohistochemistry Positive Staining | In Situ Hybridization Positive
Item
her2+ patients by local laboratory testing (ihc 3+ staining or in situ hybridization positive).
boolean
C2348909 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0487602 (UMLS CUI [2,3])
C0162788 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Trastuzumab To be stopped | Taxane To be stopped | Neoadjuvant Chemotherapy To be stopped | Adjuvant Chemotherapy To be stopped
Item
prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
boolean
C0728747 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C1272691 (UMLS CUI [3,3])
C0085533 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
Breast Carcinoma Therapeutic procedure To be stopped | Prior adjuvant endocrine therapy To be stopped | Neoplasm Metastasis Hormone Therapy To be stopped | Diphosphonates allowed
Item
prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
boolean
C0678222 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
C0281266 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C1272691 (UMLS CUI [3,3])
C0012544 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Pregnancy test negative
Item
documentation of negative pregnancy test.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
mTOR Inhibitors Cancer treatment
Item
prior mtor inhibitors for the treatment of cancer.
boolean
C1515672 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Cancer treatment Locally advanced breast cancer | Cancer treatment Secondary malignant neoplasm of female breast | Exception Hormone Therapy
Item
other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
boolean
C0920425 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone
Item
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
boolean
C1334988 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0153690 (UMLS CUI [4,2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
CNS metastases
Item
history of central nervous system metastasis.
boolean
C0686377 (UMLS CUI [1])
Abnormal digestive tract function | Gastrointestinal Diseases | Ulceration Upper gastrointestinal tract
Item
impairment of gastrointestinal (gi) function or gi disease or active ulceration of the upper gastrointestinal tract.
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C3887532 (UMLS CUI [3,1])
C1268997 (UMLS CUI [3,2])
Peripheral Neuropathy Serious
Item
serious peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Heart Diseases | Cardiac dysfunction
Item
cardiac disease or dysfunction.
boolean
C0018799 (UMLS CUI [1])
C3277906 (UMLS CUI [2])
Uncontrolled hypertension
Item
uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
HIV Infection
Item
hiv.
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Clinical Trial Eligibility Criteria Study Protocol
Item
pregnant, other protocol-defined inclusion/exclusion criteria may apply
boolean
C0032961 (UMLS CUI [1])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
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