ID

38365

Descripción

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

Palabras clave

  1. 12/10/19 12/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Carcinoma Breast Stage IV NCT02183805

Eligibility Carcinoma Breast Stage IV NCT02183805

Inclusion Criteria
Descripción

Inclusion Criteria

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

ECOG performance status

Tipo de datos

boolean

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

Breast Carcinoma | Recurrent disease Locally | Neoplasm Metastasis

Tipo de datos

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).
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Organ function

Tipo de datos

boolean

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

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

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

Central Nervous System Involvement Uncontrolled

Tipo de datos

boolean

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

Childbearing Potential Contraceptive methods Unwilling

Tipo de datos

boolean

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

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
organ dysfunction.
Descripción

Organ dysfunction

Tipo de datos

boolean

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

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Carcinoma Breast Stage IV NCT02183805

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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