ID

14786

Descrizione

A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02301988

collegamento

https://clinicaltrials.gov/show/NCT02301988

Keywords

versioni (1)
  1. 28/04/16 28/04/16 -
Caricato su

28 aprile 2016

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02301988

Inglese

Eligibility Breast Cancer NCT02301988

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
premenopausal or postmenopausal women, age >/=18 years
Descrizione

Gender | Premenopausal state | Postmenopausal state | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232969
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0001779
eastern cooperative oncology group (ecog) performance status of 0 or 1
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
histologically documented, stage ia to operable stage iiia, triple-negative carcinoma of the breast with primary tumor >/=1.5 cm in largest diameter (ct1-3) by magnetic resonance imaging (mri)
Descrizione

malignant neoplasm of breast staging | Triple-Negative Breast Cancer Finding | primary tumor | Magnetic Resonance Imaging

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2216702
UMLS CUI [2]
C2348819
UMLS CUI [3]
C0677930
UMLS CUI [4]
C0024485
adequate hematologic and organ function within 14 days before the first study treatment
Descrizione

Hematologic function | body system or organ function | Therapies, Investigational

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
UMLS CUI [3]
C0949266
availability of tumor tissue from formalin-fixed, paraffin-embedded (ffpe) core biopsy of breast primary tumor
Descrizione

Tumor tissue sample Formalin-fixed paraffin-embedded tissue specimen Core biopsy of breast primary tumor

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2711483
UMLS CUI [1,3]
C0842740
UMLS CUI [1,4]
C0677930
for female patients of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment
Descrizione

Gender | Childbearing Potential Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
known her2-positive, er-positive, or pgr-positive breast cancer
Descrizione

HER2-positive carcinoma of breast | ESTROGEN RECEPTOR (ER) OR PROGESTERONE RECEPTOR (PR) POSITIVE BREAST CANCER

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C1971473
any prior treatment for the current primary invasive breast cancer
Descrizione

Prior Therapy Invasive breast carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0853879
patients with ct4 or cn3 stage breast tumors
Descrizione

malignant neoplasm of breast staging

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2216702
metastatic (stage iv) breast cancer
Descrizione

Carcinoma breast stage IV

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0278488
bilateral invasive breast cancer
Descrizione

Invasive breast carcinoma Bilateral

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
multicentric breast cancer
Descrizione

Multicentric Breast Carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2986664
any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Descrizione

Disease | Metabolic Dysfunction | Physical Examination | Laboratory test finding | Contraindication Investigational New Drugs | Affecting research results | Complications of treatment

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C0311400
UMLS CUI [2,2]
C3887504
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0587081
UMLS CUI [5,1]
C0522473
UMLS CUI [5,2]
C0013230
UMLS CUI [6,1]
C0392760
UMLS CUI [6,2]
C0683954
UMLS CUI [7]
C0679861
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Similar models

Eligibility Breast Cancer NCT02301988

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Premenopausal state | Postmenopausal state | Age
Item
premenopausal or postmenopausal women, age >/=18 years
boolean
C0079399 (UMLS CUI [1])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
malignant neoplasm of breast staging | Triple-Negative Breast Cancer Finding | primary tumor | Magnetic Resonance Imaging
Item
histologically documented, stage ia to operable stage iiia, triple-negative carcinoma of the breast with primary tumor >/=1.5 cm in largest diameter (ct1-3) by magnetic resonance imaging (mri)
boolean
C2216702 (UMLS CUI [1])
C2348819 (UMLS CUI [2])
C0677930 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
Hematologic function | body system or organ function | Therapies, Investigational
Item
adequate hematologic and organ function within 14 days before the first study treatment
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Tumor tissue sample Formalin-fixed paraffin-embedded tissue specimen Core biopsy of breast primary tumor
Item
availability of tumor tissue from formalin-fixed, paraffin-embedded (ffpe) core biopsy of breast primary tumor
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C0842740 (UMLS CUI [1,3])
C0677930 (UMLS CUI [1,4])
Gender | Childbearing Potential Contraceptive methods
Item
for female patients of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
HER2-positive carcinoma of breast | ESTROGEN RECEPTOR (ER) OR PROGESTERONE RECEPTOR (PR) POSITIVE BREAST CANCER
Item
known her2-positive, er-positive, or pgr-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
C1971473 (UMLS CUI [2])
Prior Therapy Invasive breast carcinoma
Item
any prior treatment for the current primary invasive breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
malignant neoplasm of breast staging
Item
patients with ct4 or cn3 stage breast tumors
boolean
C2216702 (UMLS CUI [1])
Carcinoma breast stage IV
Item
metastatic (stage iv) breast cancer
boolean
C0278488 (UMLS CUI [1])
Invasive breast carcinoma Bilateral
Item
bilateral invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Multicentric Breast Carcinoma
Item
multicentric breast cancer
boolean
C2986664 (UMLS CUI [1])
Disease | Metabolic Dysfunction | Physical Examination | Laboratory test finding | Contraindication Investigational New Drugs | Affecting research results | Complications of treatment
Item
any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
boolean
C0012634 (UMLS CUI [1])
C0311400 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])
C0587081 (UMLS CUI [4])
C0522473 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C0392760 (UMLS CUI [6,1])
C0683954 (UMLS CUI [6,2])
C0679861 (UMLS CUI [7])
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