ID

35027

Beschrijving

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

Trefwoorden

  1. 10-02-19 10-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 februari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02441946

Eligibility Breast Cancer NCT02441946

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
have postmenopausal status.
Beschrijving

Postmenopausal state

Datatype

boolean

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

Breast adenocarcinoma

Datatype

boolean

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

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

Datatype

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.
Beschrijving

Hormone Therapy Neoadjuvant

Datatype

boolean

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

Breast Carcinoma Primary Core needle biopsy

Datatype

boolean

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

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral invasive breast cancer.
Beschrijving

Invasive carcinoma of breast Bilateral

Datatype

boolean

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

Secondary malignant neoplasm of female breast

Datatype

boolean

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

Inflammatory Breast Carcinoma

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Radiotherapy to chest wall Ipsilateral Malignant Neoplasm

Datatype

boolean

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

Antioestrogen therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0854638

Similar models

Eligibility Breast Cancer NCT02441946

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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