ID

15287

Description

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

Link

https://clinicaltrials.gov/show/NCT02333370

Keywords

Versions (1)
  1. 5/25/16 5/25/16 -
Uploaded on

May 25, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer NCT02333370

English

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

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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.
Description

Postmenopausal state

Data type

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
Description

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

Data type

boolean

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

Human epidermal growth factor 2 negative carcinoma of breast

Data type

boolean

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

Bone Marrow physiological aspects | organ function

Data type

boolean

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

Exclusion Criteria

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

CDK4/6 Inhibition

Data type

boolean

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

Hypersensitivity LEE011 Excipient | Hypersensitivity letrozole Excipient

Data type

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.
Description

Inflammatory Breast Carcinoma

Data type

boolean

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

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

Data type

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
Description

Cancer treatment Other

Data type

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.
Description

major surgery | Investigational New Drugs | adverse effects Major

Data type

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
Description

Therapeutic radiology procedure

Data type

boolean

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

Malignant Neoplasms

Data type

boolean

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

CNS metastases

Data type

boolean

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

HIV Infections

Data type

boolean

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

Inclusion Other | Exclusion Criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0205394
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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