ID

32598

Beschreibung

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

Stichworte

Versionen (1)
  1. 08.11.18 08.11.18 -
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See clinicaltrials.gov

Hochgeladen am

8. November 2018

DOI

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Creative Commons BY 4.0
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Eligibility Triple Negative Breast Cancer NCT00813956

Englisch

Eligibility Triple Negative Breast Cancer NCT00813956

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive breast cancer
Beschreibung

Invasive carcinoma of breast

Datentyp

boolean

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

Disease TNM clinical staging

Datentyp

boolean

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

Triple-Negative Breast Cancer Finding

Datentyp

boolean

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

Prior Therapy Absent Breast Carcinoma

Datentyp

boolean

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

Age

Datentyp

boolean

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

Renal function | Liver function

Datentyp

boolean

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

Hematologic function

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Eligibility Determination Breast-Conserving Surgery

Datentyp

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
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

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
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic breast cancer
Beschreibung

Secondary malignant neoplasm of female breast

Datentyp

boolean

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

Breast Carcinoma Inoperable TNM clinical staging

Datentyp

boolean

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

Tumor size

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Hormone receptor positive malignant neoplasm of breast

Datentyp

boolean

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

HER2-positive carcinoma of breast

Datentyp

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
Beschreibung

Condition Study Subject Participation Status Inappropriate | Condition compromises Protocol Compliance

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Triple Negative Breast Cancer NCT00813956

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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