ID

32598

Descrição

A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00813956

Link

https://clinicaltrials.gov/show/NCT00813956

Palavras-chave

Versões (1)
  1. 08/11/2018 08/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Triple Negative Breast Cancer NCT00813956

Inglês

Eligibility Triple Negative Breast Cancer NCT00813956

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive breast cancer
Descrição

Invasive carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0853879
stage i-iiia disease
Descrição

Disease TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
er, pr, her2/neu-negative status
Descrição

Triple-Negative Breast Cancer Finding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348819
no prior treatment for breast cancer
Descrição

Prior Therapy Absent Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
age 18 years of greater
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
normal renal, liver function
Descrição

Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
normal hematologic status
Descrição

Hematologic function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
ecog performance status 0, 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
evaluation by a surgeon to determine breast conservation eligibility
Descrição

Eligibility Determination Breast-Conserving Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C0917927
women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
Descrição

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
ability to understand and the willingness to sign a written informed consent document
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic breast cancer
Descrição

Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0346993
inoperable breast cancer, including stage iiib and iiic
Descrição

Breast Carcinoma Inoperable TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C3258246
tumor size less than 1 centimeter
Descrição

Tumor size

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0475440
prior surgery, systemic therapy, or radiotherapy for the current cancer
Descrição

Operative Surgical Procedures Previous Malignant Neoplasm | Systemic therapy Malignant Neoplasm | Prior radiation therapy Malignant Neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0006826
hormone receptor-positive breast cancer
Descrição

Hormone receptor positive malignant neoplasm of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1562029
her2/neu-positive breast cancer
Descrição

HER2-positive carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960398
any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
Descrição

Condition Study Subject Participation Status Inappropriate | Condition compromises Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
pregnant or nursing women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
receipt of any investigational agents within 30 days prior to commencing study treatment
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Triple Negative Breast Cancer NCT00813956

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage i-iiia disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Triple-Negative Breast Cancer Finding
Item
er, pr, her2/neu-negative status
boolean
C2348819 (UMLS CUI [1])
Prior Therapy Absent Breast Carcinoma
Item
no prior treatment for breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Age
Item
age 18 years of greater
boolean
C0001779 (UMLS CUI [1])
Renal function | Liver function
Item
normal renal, liver function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Hematologic function
Item
normal hematologic status
boolean
C0221130 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0, 1
boolean
C1520224 (UMLS CUI [1])
Eligibility Determination Breast-Conserving Surgery
Item
evaluation by a surgeon to determine breast conservation eligibility
boolean
C0013893 (UMLS CUI [1,1])
C0917927 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Breast Carcinoma Inoperable TNM clinical staging
Item
inoperable breast cancer, including stage iiib and iiic
boolean
C0678222 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Tumor size
Item
tumor size less than 1 centimeter
boolean
C0475440 (UMLS CUI [1])
Operative Surgical Procedures Previous Malignant Neoplasm | Systemic therapy Malignant Neoplasm | Prior radiation therapy Malignant Neoplasm
Item
prior surgery, systemic therapy, or radiotherapy for the current cancer
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Hormone receptor positive malignant neoplasm of breast
Item
hormone receptor-positive breast cancer
boolean
C1562029 (UMLS CUI [1])
HER2-positive carcinoma of breast
Item
her2/neu-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Condition Study Subject Participation Status Inappropriate | Condition compromises Protocol Compliance
Item
any concurrent condition which in the investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
receipt of any investigational agents within 30 days prior to commencing study treatment
boolean
C0013230 (UMLS CUI [1])
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