ID

15287

Beskrivning

Phase Ib Dose-escalation, Phase II Study of LEE011 and Letrozole for Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02333370

Länk

https://clinicaltrials.gov/show/NCT02333370

Nyckelord

Versioner (1)
  1. 2016-05-25 2016-05-25 -
Uppladdad den

25 maj 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

Engelsk

Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy).
Beskrivning

Gender | Locally advanced breast cancer Recurrent | Advanced breast cancer metastatic | curative treatment | Curative Surgery | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C3495917
UMLS CUI [3,2]
C1522484
UMLS CUI [4]
C1273390
UMLS CUI [5]
C1511562
UMLS CUI [6]
C1522449
patient is postmenopausal.
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer
Beskrivning

estrogen or progesterone receptor positive for breast cancer | Histology | Cytology

Datatyp

boolean

Alias
UMLS CUI [1]
C2367479
UMLS CUI [2]
C0344441
UMLS CUI [3]
C1305671
patient has her2-negative breast cancer
Beskrivning

Human epidermal growth factor 2 negative carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C2316304
patient has adequate bone marrow and organ function
Beskrivning

Bone Marrow physiological aspects | organ function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who received any cdk4/6 inhibitor.
Beskrivning

CDK4/6 Inhibition

Datatyp

boolean

Alias
UMLS CUI [1]
C3899807
patient has a known hypersensitivity to any of the excipients of lee011 or letrozole
Beskrivning

Hypersensitivity LEE011 Excipient | Hypersensitivity letrozole Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2987342
UMLS CUI [1,3]
C0015237
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0246421
UMLS CUI [2,3]
C0015237
patients with inflammatory breast cancer.
Beskrivning

Inflammatory Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0278601
patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
Beskrivning

Advanced breast cancer | Cancer treatment Systemic | Hormone Therapy | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C3495917
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0392920
patient is currently using other anti-cancer therapy
Beskrivning

Cancer treatment Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Beskrivning

major surgery | Investigational New Drugs | adverse effects Major

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0001688
UMLS CUI [3,2]
C0205164
patient who has received radiotherapy ≤ 4 weeks
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
patient has a concurrent malignancy or malignancy within 3 years
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
patient has metastases to the central nervous system (cns).
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
patient has a known history of hiv infection
Beskrivning

HIV Infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Inclusion Other | Exclusion Criteria Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0205394
Tillbaka till toppen

Similar models

Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Locally advanced breast cancer Recurrent | Advanced breast cancer metastatic | curative treatment | Curative Surgery | Therapeutic radiology procedure
Item
women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy).
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C3495917 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
C1273390 (UMLS CUI [4])
C1511562 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Postmenopausal state
Item
patient is postmenopausal.
boolean
C0232970 (UMLS CUI [1])
estrogen or progesterone receptor positive for breast cancer | Histology | Cytology
Item
patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer
boolean
C2367479 (UMLS CUI [1])
C0344441 (UMLS CUI [2])
C1305671 (UMLS CUI [3])
Human epidermal growth factor 2 negative carcinoma of breast
Item
patient has her2-negative breast cancer
boolean
C2316304 (UMLS CUI [1])
Bone Marrow physiological aspects | organ function
Item
patient has adequate bone marrow and organ function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
CDK4/6 Inhibition
Item
patient who received any cdk4/6 inhibitor.
boolean
C3899807 (UMLS CUI [1])
Hypersensitivity LEE011 Excipient | Hypersensitivity letrozole Excipient
Item
patient has a known hypersensitivity to any of the excipients of lee011 or letrozole
boolean
C0020517 (UMLS CUI [1,1])
C2987342 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0246421 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Inflammatory Breast Carcinoma
Item
patients with inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
Advanced breast cancer | Cancer treatment Systemic | Hormone Therapy | Chemotherapy
Item
patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
boolean
C3495917 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Cancer treatment Other
Item
patient is currently using other anti-cancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
major surgery | Investigational New Drugs | adverse effects Major
Item
patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
boolean
C0679637 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0001688 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Therapeutic radiology procedure
Item
patient who has received radiotherapy ≤ 4 weeks
boolean
C1522449 (UMLS CUI [1])
Malignant Neoplasms
Item
patient has a concurrent malignancy or malignancy within 3 years
boolean
C0006826 (UMLS CUI [1])
CNS metastases
Item
patient has metastases to the central nervous system (cns).
boolean
C0686377 (UMLS CUI [1])
HIV Infections
Item
patient has a known history of hiv infection
boolean
C0019693 (UMLS CUI [1])
Inclusion Other | Exclusion Criteria Other
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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