ID

38058

Description

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation; ODM derived from: https://clinicaltrials.gov/show/NCT01572727

Lien

https://clinicaltrials.gov/show/NCT01572727

Mots-clés

Versions (1)
  1. 12/09/2019 12/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

12 septembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Cancer NCT01572727

Anglais

Eligibility Breast Cancer NCT01572727

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer that is locally advanced or metastatic
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Type de données

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
her2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
Description

Disease HER2 Negative | Hormone Receptor Status Known | Breast Carcinoma Classification Test

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348908
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0205309
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0008902
UMLS CUI [3,3]
C0392366
a tumor sample must be shipped to a central lab for identification of biomarkers (pi3k activation status) before randomization
Description

Tumor tissue sample | Biomarker Identification | PI3K Activation Status

Type de données

boolean

Alias
UMLS CUI [1]
C0475358
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C0205396
UMLS CUI [3,1]
C2936824
UMLS CUI [3,2]
C1879547
UMLS CUI [3,3]
C0449438
adequate bone marrow and organ function
Description

Bone Marrow function | Organ function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
measurable or non-measurable disease
Description

Measurable Disease | Non-Measurable Lesion

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for locally advanced or metastatic disease
Description

Prior Chemotherapy Advanced disease Locally | Prior Chemotherapy Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0027627
previous treatment with pi3k or akt inhibitors
Description

Prior Therapy | PI3K Inhibitor | AKT Inhibitor

Type de données

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1519050
UMLS CUI [3,1]
C0812228
UMLS CUI [3,2]
C1999216
symptomatic brain metastases
Description

Metastatic malignant neoplasm to brain Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
concurrent malignancy or malignancy within 3 years prior to start of study treatment
Description

Cancer Other

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
certain drugs or radiation within 2-4 weeks of enrollment
Description

Pharmaceutical Preparations Specific Recently | Therapeutic radiology procedure Recently

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Description

Adrenal Cortex Hormones Increased | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increased | Immunosuppressive Agents chronic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205217
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0021081
UMLS CUI [3,2]
C0205217
UMLS CUI [4,1]
C0021081
UMLS CUI [4,2]
C0205191
active heart (cardiac) disease as defined in the protocol
Description

Heart Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
known hypersensitivity or contraindications to use paclitaxel
Description

Paclitaxel allergy | Medical contraindication Paclitaxel

Type de données

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0144576
pregnant or nursing (lactating) woman
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
certain scores on an anxiety and depression mood questionaire given at screening
Description

Anxiety Questionnaire Score | Depressed mood Questionnaire Score

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003467
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0449820
UMLS CUI [2,1]
C0344315
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0449820
other protocol defined criteria may apply
Description

Eligibility Criteria Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT01572727

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
breast cancer that is locally advanced or metastatic
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Disease HER2 Negative | Hormone Receptor Status Known | Breast Carcinoma Classification Test
Item
her2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
boolean
C0012634 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0019929 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0008902 (UMLS CUI [3,2])
C0392366 (UMLS CUI [3,3])
Tumor tissue sample | Biomarker Identification | PI3K Activation Status
Item
a tumor sample must be shipped to a central lab for identification of biomarkers (pi3k activation status) before randomization
boolean
C0475358 (UMLS CUI [1])
C0005516 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C2936824 (UMLS CUI [3,1])
C1879547 (UMLS CUI [3,2])
C0449438 (UMLS CUI [3,3])
Bone Marrow function | Organ function
Item
adequate bone marrow and organ function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Measurable Disease | Non-Measurable Lesion
Item
measurable or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Advanced disease Locally | Prior Chemotherapy Neoplasm Metastasis
Item
prior chemotherapy for locally advanced or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Prior Therapy | PI3K Inhibitor | AKT Inhibitor
Item
previous treatment with pi3k or akt inhibitors
boolean
C1514463 (UMLS CUI [1])
C1519050 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Cancer Other
Item
concurrent malignancy or malignancy within 3 years prior to start of study treatment
boolean
C1707251 (UMLS CUI [1])
Pharmaceutical Preparations Specific Recently | Therapeutic radiology procedure Recently
Item
certain drugs or radiation within 2-4 weeks of enrollment
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Adrenal Cortex Hormones Increased | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increased | Immunosuppressive Agents chronic
Item
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
boolean
C0001617 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3,1])
C0205217 (UMLS CUI [3,2])
C0021081 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Heart Disease
Item
active heart (cardiac) disease as defined in the protocol
boolean
C0018799 (UMLS CUI [1])
Paclitaxel allergy | Medical contraindication Paclitaxel
Item
known hypersensitivity or contraindications to use paclitaxel
boolean
C0570707 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Anxiety Questionnaire Score | Depressed mood Questionnaire Score
Item
certain scores on an anxiety and depression mood questionaire given at screening
boolean
C0003467 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0344315 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol defined criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial