ID

38197

Beskrivning

A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Front-line Treatment for Patients With Metastatic Triple-Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02162719

Länk

https://clinicaltrials.gov/show/NCT02162719

Nyckelord

Versioner (1)
  1. 2019-09-26 2019-09-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02162719

Engelsk

Eligibility Breast Cancer NCT02162719

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
Beskrivning

Breast adenocarcinoma Triple Negative | Breast adenocarcinoma Inoperable Advanced Locally | Breast adenocarcinoma metastatic Inoperable | Breast adenocarcinoma Inappropriate Excision Curative intent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C3539878
UMLS CUI [2,1]
C0858252
UMLS CUI [2,2]
C0205187
UMLS CUI [2,3]
C0205179
UMLS CUI [2,4]
C1517927
UMLS CUI [3,1]
C1697918
UMLS CUI [3,2]
C0205187
UMLS CUI [4,1]
C0858252
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0728940
UMLS CUI [4,4]
C1276305
premenopausal or postmenopausal women aged >/=18 years
Beskrivning

Premenopausal state | Postmenopausal state | Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
availability of a representative formalin-fixed, paraffin-embedded (ffpe) tumor specimen, required prior to randomization
Beskrivning

Availability of Tumor tissue sample Formalin-fixed paraffin-embedded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C2711483
measurable disease, according to the response evaluation criteria in solid tumors (recist) criteria, version 1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
adequate hematologic and organ function within 14 days before the first study treatment
Beskrivning

Hematologic function | Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
for female patients of childbearing potential, agreement (by both patient and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment
Beskrivning

Childbearing Potential Contraceptive methods | Partner in relationship Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast
Beskrivning

Prior Therapy Breast adenocarcinoma Triple Negative | Prior Therapy Breast adenocarcinoma Inoperable Advanced Locally | Prior Therapy Breast adenocarcinoma metastatic Inoperable | Prior Chemotherapy Breast adenocarcinoma Triple Negative | Prior Chemotherapy Breast adenocarcinoma Inoperable Advanced Locally | Prior Chemotherapy Breast adenocarcinoma metastatic Inoperable | Prior Hormone Therapy Breast adenocarcinoma Triple Negative | Prior Hormone Therapy Breast adenocarcinoma Inoperable Advanced Locally | Prior Hormone Therapy Breast adenocarcinoma metastatic Inoperable | Targeted Therapy Breast adenocarcinoma Triple Negative | Targeted Therapy Breast adenocarcinoma Inoperable Advanced Locally | Targeted Therapy Breast adenocarcinoma metastatic Inoperable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0858252
UMLS CUI [1,3]
C3539878
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0858252
UMLS CUI [2,3]
C0205187
UMLS CUI [2,4]
C0205179
UMLS CUI [2,5]
C1517927
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1697918
UMLS CUI [3,3]
C0205187
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0858252
UMLS CUI [4,3]
C3539878
UMLS CUI [5,1]
C1514457
UMLS CUI [5,2]
C0858252
UMLS CUI [5,3]
C0205187
UMLS CUI [5,4]
C0205179
UMLS CUI [5,5]
C1517927
UMLS CUI [6,1]
C1514457
UMLS CUI [6,2]
C1697918
UMLS CUI [6,3]
C0205187
UMLS CUI [7,1]
C1514460
UMLS CUI [7,2]
C0858252
UMLS CUI [7,3]
C3539878
UMLS CUI [8,1]
C1514460
UMLS CUI [8,2]
C0858252
UMLS CUI [8,3]
C0205187
UMLS CUI [8,4]
C0205179
UMLS CUI [8,5]
C1517927
UMLS CUI [9,1]
C1514460
UMLS CUI [9,2]
C1697918
UMLS CUI [9,3]
C0205187
UMLS CUI [10,1]
C2985566
UMLS CUI [10,2]
C0858252
UMLS CUI [10,3]
C3539878
UMLS CUI [11,1]
C2985566
UMLS CUI [11,2]
C0858252
UMLS CUI [11,3]
C0205187
UMLS CUI [11,4]
C0205179
UMLS CUI [11,5]
C1517927
UMLS CUI [12,1]
C2985566
UMLS CUI [12,2]
C1697918
UMLS CUI [12,3]
C0205187
patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed >/= 6 months prior to cycle 1 day 1
Beskrivning

Neoadjuvant Chemotherapy Breast adenocarcinoma Triple Negative | Adjuvant Chemotherapy Breast adenocarcinoma Triple Negative | Prior radiation therapy Breast adenocarcinoma Triple Negative | Neoadjuvant Chemotherapy Breast adenocarcinoma Advanced Locally | Adjuvant Chemotherapy Breast adenocarcinoma Advanced Locally | Prior radiation therapy Breast adenocarcinoma Advanced Locally

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0858252
UMLS CUI [1,4]
C3539878
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0858252
UMLS CUI [2,3]
C3539878
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0858252
UMLS CUI [3,3]
C3539878
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C3665472
UMLS CUI [4,3]
C0858252
UMLS CUI [4,4]
C0205179
UMLS CUI [4,5]
C1517927
UMLS CUI [5,1]
C0085533
UMLS CUI [5,2]
C0858252
UMLS CUI [5,3]
C0205179
UMLS CUI [5,4]
C1517927
UMLS CUI [6,1]
C0279134
UMLS CUI [6,2]
C0858252
UMLS CUI [6,3]
C0205179
UMLS CUI [6,4]
C1517927
any radiation treatment to metastatic site within 28 days of cycle 1, day 1
Beskrivning

Therapeutic radiology procedure Site metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1522484
known her2 positive, er positive, or pr positive breast cancer
Beskrivning

HER2-positive carcinoma of breast | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive

Datatyp

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C2938924
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0279759
previous therapy with akt, pi3k, and/or mtor inhibitors
Beskrivning

Prior Therapy | AKT inhibitors | PI3K Inhibitor | mTOR Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0812228
UMLS CUI [2,2]
C0243077
UMLS CUI [3]
C1519050
UMLS CUI [4]
C2746052
major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
Beskrivning

Major surgery | Open biopsy | Traumatic injury | Patient need for Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0679637
known presence of the brain or spinal cord metastasis, as determined by ct or magnetic resonance imaging (mri) evaluation during screening or prior radiographic assessments
Beskrivning

Metastatic malignant neoplasm to brain CT | Secondary malignant neoplasm of spinal cord CT | Metastatic malignant neoplasm to brain MRI | Secondary malignant neoplasm of spinal cord MRI | Metastatic malignant neoplasm to brain Radiography | Secondary malignant neoplasm of spinal cord Radiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0347016
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0347016
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0220650
UMLS CUI [5,2]
C0034571
UMLS CUI [6,1]
C0347016
UMLS CUI [6,2]
C0034571
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Similar models

Eligibility Breast Cancer NCT02162719

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Triple Negative | Breast adenocarcinoma Inoperable Advanced Locally | Breast adenocarcinoma metastatic Inoperable | Breast adenocarcinoma Inappropriate Excision Curative intent
Item
histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
boolean
C0858252 (UMLS CUI [1,1])
C3539878 (UMLS CUI [1,2])
C0858252 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C1697918 (UMLS CUI [3,1])
C0205187 (UMLS CUI [3,2])
C0858252 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0728940 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
Premenopausal state | Postmenopausal state | Age
Item
premenopausal or postmenopausal women aged >/=18 years
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Availability of Tumor tissue sample Formalin-fixed paraffin-embedded
Item
availability of a representative formalin-fixed, paraffin-embedded (ffpe) tumor specimen, required prior to randomization
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C2711483 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease, according to the response evaluation criteria in solid tumors (recist) criteria, version 1.1
boolean
C1513041 (UMLS CUI [1])
Hematologic function | Organ function
Item
adequate hematologic and organ function within 14 days before the first study treatment
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Partner in relationship Contraceptive methods
Item
for female patients of childbearing potential, agreement (by both patient and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Breast adenocarcinoma Triple Negative | Prior Therapy Breast adenocarcinoma Inoperable Advanced Locally | Prior Therapy Breast adenocarcinoma metastatic Inoperable | Prior Chemotherapy Breast adenocarcinoma Triple Negative | Prior Chemotherapy Breast adenocarcinoma Inoperable Advanced Locally | Prior Chemotherapy Breast adenocarcinoma metastatic Inoperable | Prior Hormone Therapy Breast adenocarcinoma Triple Negative | Prior Hormone Therapy Breast adenocarcinoma Inoperable Advanced Locally | Prior Hormone Therapy Breast adenocarcinoma metastatic Inoperable | Targeted Therapy Breast adenocarcinoma Triple Negative | Targeted Therapy Breast adenocarcinoma Inoperable Advanced Locally | Targeted Therapy Breast adenocarcinoma metastatic Inoperable
Item
any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast
boolean
C1514463 (UMLS CUI [1,1])
C0858252 (UMLS CUI [1,2])
C3539878 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0858252 (UMLS CUI [2,2])
C0205187 (UMLS CUI [2,3])
C0205179 (UMLS CUI [2,4])
C1517927 (UMLS CUI [2,5])
C1514463 (UMLS CUI [3,1])
C1697918 (UMLS CUI [3,2])
C0205187 (UMLS CUI [3,3])
C1514457 (UMLS CUI [4,1])
C0858252 (UMLS CUI [4,2])
C3539878 (UMLS CUI [4,3])
C1514457 (UMLS CUI [5,1])
C0858252 (UMLS CUI [5,2])
C0205187 (UMLS CUI [5,3])
C0205179 (UMLS CUI [5,4])
C1517927 (UMLS CUI [5,5])
C1514457 (UMLS CUI [6,1])
C1697918 (UMLS CUI [6,2])
C0205187 (UMLS CUI [6,3])
C1514460 (UMLS CUI [7,1])
C0858252 (UMLS CUI [7,2])
C3539878 (UMLS CUI [7,3])
C1514460 (UMLS CUI [8,1])
C0858252 (UMLS CUI [8,2])
C0205187 (UMLS CUI [8,3])
C0205179 (UMLS CUI [8,4])
C1517927 (UMLS CUI [8,5])
C1514460 (UMLS CUI [9,1])
C1697918 (UMLS CUI [9,2])
C0205187 (UMLS CUI [9,3])
C2985566 (UMLS CUI [10,1])
C0858252 (UMLS CUI [10,2])
C3539878 (UMLS CUI [10,3])
C2985566 (UMLS CUI [11,1])
C0858252 (UMLS CUI [11,2])
C0205187 (UMLS CUI [11,3])
C0205179 (UMLS CUI [11,4])
C1517927 (UMLS CUI [11,5])
C2985566 (UMLS CUI [12,1])
C1697918 (UMLS CUI [12,2])
C0205187 (UMLS CUI [12,3])
Neoadjuvant Chemotherapy Breast adenocarcinoma Triple Negative | Adjuvant Chemotherapy Breast adenocarcinoma Triple Negative | Prior radiation therapy Breast adenocarcinoma Triple Negative | Neoadjuvant Chemotherapy Breast adenocarcinoma Advanced Locally | Adjuvant Chemotherapy Breast adenocarcinoma Advanced Locally | Prior radiation therapy Breast adenocarcinoma Advanced Locally
Item
patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed >/= 6 months prior to cycle 1 day 1
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0858252 (UMLS CUI [1,3])
C3539878 (UMLS CUI [1,4])
C0085533 (UMLS CUI [2,1])
C0858252 (UMLS CUI [2,2])
C3539878 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0858252 (UMLS CUI [3,2])
C3539878 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4,1])
C3665472 (UMLS CUI [4,2])
C0858252 (UMLS CUI [4,3])
C0205179 (UMLS CUI [4,4])
C1517927 (UMLS CUI [4,5])
C0085533 (UMLS CUI [5,1])
C0858252 (UMLS CUI [5,2])
C0205179 (UMLS CUI [5,3])
C1517927 (UMLS CUI [5,4])
C0279134 (UMLS CUI [6,1])
C0858252 (UMLS CUI [6,2])
C0205179 (UMLS CUI [6,3])
C1517927 (UMLS CUI [6,4])
Therapeutic radiology procedure Site metastatic
Item
any radiation treatment to metastatic site within 28 days of cycle 1, day 1
boolean
C1522449 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
HER2-positive carcinoma of breast | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive
Item
known her2 positive, er positive, or pr positive breast cancer
boolean
C1960398 (UMLS CUI [1])
C2938924 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
Prior Therapy | AKT inhibitors | PI3K Inhibitor | mTOR Inhibitor
Item
previous therapy with akt, pi3k, and/or mtor inhibitors
boolean
C1514463 (UMLS CUI [1])
C0812228 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C1519050 (UMLS CUI [3])
C2746052 (UMLS CUI [4])
Major surgery | Open biopsy | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0679637 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain CT | Secondary malignant neoplasm of spinal cord CT | Metastatic malignant neoplasm to brain MRI | Secondary malignant neoplasm of spinal cord MRI | Metastatic malignant neoplasm to brain Radiography | Secondary malignant neoplasm of spinal cord Radiography
Item
known presence of the brain or spinal cord metastasis, as determined by ct or magnetic resonance imaging (mri) evaluation during screening or prior radiographic assessments
boolean
C0220650 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0347016 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0347016 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0220650 (UMLS CUI [5,1])
C0034571 (UMLS CUI [5,2])
C0347016 (UMLS CUI [6,1])
C0034571 (UMLS CUI [6,2])
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