ID

35027

Description

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02441946

Link

https://clinicaltrials.gov/show/NCT02441946

Keywords

  1. 2/10/19 2/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT02441946

Eligibility Breast Cancer NCT02441946

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have postmenopausal status.
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
adenocarcinoma of the breast.
Description

Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
breast tumor ≥1 centimeter (cm) in diameter, hr+, her2-.
Description

Breast Carcinoma Hormone Receptor Positive Diameter | HER2 negative carcinoma of breast Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C1301886
UMLS CUI [2,1]
C2316304
UMLS CUI [2,2]
C1301886
neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
Description

Hormone Therapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1298676
primary breast cancer that is suitable for baseline core biopsy.
Description

Breast Carcinoma Primary Core needle biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1318309
have adequate organ function.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral invasive breast cancer.
Description

Invasive carcinoma of breast Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
metastatic breast cancer (local spread to axillary lymph nodes is permitted).
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
inflammatory breast cancer.
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
Description

Systemic therapy Invasive carcinoma of breast Ipsilateral | Systemic therapy Breast Carcinoma Ipsilateral | Therapeutic radiology procedure Invasive carcinoma of breast Ipsilateral | Therapeutic radiology procedure Breast Carcinoma Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0853879
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0441989
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0853879
UMLS CUI [3,3]
C0441989
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C0441989
prior radiotherapy to the ipsilateral chest wall for any malignancy.
Description

Radiotherapy to chest wall Ipsilateral Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C1998066
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0006826
prior anti-estrogen therapy.
Description

Antioestrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C0854638

Similar models

Eligibility Breast Cancer NCT02441946

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
have postmenopausal status.
boolean
C0232970 (UMLS CUI [1])
Breast adenocarcinoma
Item
adenocarcinoma of the breast.
boolean
C0858252 (UMLS CUI [1])
Breast Carcinoma Hormone Receptor Positive Diameter | HER2 negative carcinoma of breast Diameter
Item
breast tumor ≥1 centimeter (cm) in diameter, hr+, her2-.
boolean
C0678222 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
C2316304 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
Hormone Therapy Neoadjuvant
Item
neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
Breast Carcinoma Primary Core needle biopsy
Item
primary breast cancer that is suitable for baseline core biopsy.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
Organ function
Item
have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Bilateral
Item
bilateral invasive breast cancer.
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer (local spread to axillary lymph nodes is permitted).
boolean
C0346993 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
Systemic therapy Invasive carcinoma of breast Ipsilateral | Systemic therapy Breast Carcinoma Ipsilateral | Therapeutic radiology procedure Invasive carcinoma of breast Ipsilateral | Therapeutic radiology procedure Breast Carcinoma Ipsilateral
Item
prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
boolean
C1515119 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0853879 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0441989 (UMLS CUI [4,3])
Radiotherapy to chest wall Ipsilateral Malignant Neoplasm
Item
prior radiotherapy to the ipsilateral chest wall for any malignancy.
boolean
C1998066 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Antioestrogen therapy
Item
prior anti-estrogen therapy.
boolean
C0854638 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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