ID

38365

Description

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02183805

Link

https://clinicaltrials.gov/show/NCT02183805

Keywords

Versions (1)
  1. 10/12/19 10/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma Breast Stage IV NCT02183805

English

Eligibility Carcinoma Breast Stage IV NCT02183805

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
Description

Breast Carcinoma | Recurrent disease Locally | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [3]
C0027627
UMLS CUI [4]
C0021044
documentation of estrogen and progestin receptor (er/pr) negative status and her2/neu receptor negative status (ie, fish negative or immunohistochemistry 0 or +1).
Description

Estrogen receptor negative | Progesterone receptor negative | HER2/Neu Negative | FISH | Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C0279756
UMLS CUI [2]
C0279766
UMLS CUI [3]
C2348908
UMLS CUI [4]
C0162789
UMLS CUI [5]
C0021044
obtained complete response or good partial response after first line chemotherapy.
Description

In complete remission | Partial response Good | Status post First line Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0205170
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1708063
UMLS CUI [3,3]
C0392920
normal organ function required prior to study entry.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
willingness to comply with treatment plans and other study procedures.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled central nervous system (cns) involvement with disease
Description

Central Nervous System Involvement Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0205318
fertile women unwilling to use contraceptive techniques during treatment
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
females who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
organ dysfunction.
Description

Organ dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0349410
patients may not be receiving any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Carcinoma Breast Stage IV NCT02183805

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Breast Carcinoma | Recurrent disease Locally | Neoplasm Metastasis
Item
histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
boolean
C0678222 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
C0021044 (UMLS CUI [4])
Estrogen receptor negative | Progesterone receptor negative | HER2/Neu Negative | FISH | Immunohistochemistry
Item
documentation of estrogen and progestin receptor (er/pr) negative status and her2/neu receptor negative status (ie, fish negative or immunohistochemistry 0 or +1).
boolean
C0279756 (UMLS CUI [1])
C0279766 (UMLS CUI [2])
C2348908 (UMLS CUI [3])
C0162789 (UMLS CUI [4])
C0021044 (UMLS CUI [5])
In complete remission | Partial response Good | Status post First line Chemotherapy
Item
obtained complete response or good partial response after first line chemotherapy.
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Organ function
Item
normal organ function required prior to study entry.
boolean
C0678852 (UMLS CUI [1])
Protocol Compliance
Item
willingness to comply with treatment plans and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Involvement Uncontrolled
Item
uncontrolled central nervous system (cns) involvement with disease
boolean
C4050309 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Unwilling
Item
fertile women unwilling to use contraceptive techniques during treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Pregnancy
Item
females who are pregnant
boolean
C0032961 (UMLS CUI [1])
Organ dysfunction
Item
organ dysfunction.
boolean
C0349410 (UMLS CUI [1])
Investigational New Drugs
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
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