ID

40934

Description

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01698918

Link

https://clinicaltrials.gov/show/NCT01698918

Keywords

Versions (1)
  1. 6/7/20 6/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hormone Receptor Positive Breast Cancer NCT01698918

English

Eligibility Hormone Receptor Positive Breast Cancer NCT01698918

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 18 years old or greater
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
Description

Secondary malignant neoplasm of female breast unresectable | Locally advanced breast cancer unresectable | Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0346993
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1511562
UMLS CUI [4,1]
C3495949
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1511562
UMLS CUI [5,1]
C0346993
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C1522449
UMLS CUI [5,4]
C1276305
UMLS CUI [6,1]
C3495949
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C1522449
UMLS CUI [6,4]
C1276305
histological or cytological confirmation of estrogen-receptor positive (er+) human epidermal growth factor receptor 2 negative (her2-) breast cancer
Description

Breast Carcinoma Estrogen receptor positive HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C2348908
postmenopausal women
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
no prior treatment for metastatic breast cancer
Description

Prior Therapy Absent Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0346993
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
Description

Non-Measurable Lesion | Exception Secondary malignant neoplasm of bone | Pleural effusion | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C1334988
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0153690
UMLS CUI [3]
C0032227
UMLS CUI [4]
C0003962
patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
Description

Prior Hormone Therapy Secondary malignant neoplasm of female breast | Systemic therapy Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0346993
patients may have received prior neoadjuvant or adjuvant endocrine therapy. in the case of neoadjuvant or adjuvant nsai (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
Description

Hormone Therapy Neoadjuvant allowed | Prior adjuvant endocrine therapy allowed | NSAID Neoadjuvant Treatment completed | NSAID Adjuvant Treatment completed | Letrozole Treatment completed | Anastrozole Treatment completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C0281266
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C0580352
UMLS CUI [4,1]
C0003211
UMLS CUI [4,2]
C1522673
UMLS CUI [4,3]
C0580352
UMLS CUI [5,1]
C0246421
UMLS CUI [5,2]
C0580352
UMLS CUI [6,1]
C0290883
UMLS CUI [6,2]
C0580352
previous treatment with mtor inhibitors.
Description

mTOR Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1515672
known hypersensitivity to mtor inhibitors, e.g., sirolimus (rapamycin).
Description

Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1515672
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hormone Receptor Positive Breast Cancer NCT01698918

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients 18 years old or greater
boolean
C0001779 (UMLS CUI [1])
Secondary malignant neoplasm of female breast unresectable | Locally advanced breast cancer unresectable | Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative
Item
patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
boolean
C0346993 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C3495949 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1511562 (UMLS CUI [4,3])
C0346993 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C3495949 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C1522449 (UMLS CUI [6,3])
C1276305 (UMLS CUI [6,4])
Breast Carcinoma Estrogen receptor positive HER2 Negative
Item
histological or cytological confirmation of estrogen-receptor positive (er+) human epidermal growth factor receptor 2 negative (her2-) breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C2348908 (UMLS CUI [1,3])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Prior Therapy Absent Secondary malignant neoplasm of female breast
Item
no prior treatment for metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Non-Measurable Lesion | Exception Secondary malignant neoplasm of bone | Pleural effusion | Ascites
Item
patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
boolean
C1334988 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
Prior Hormone Therapy Secondary malignant neoplasm of female breast | Systemic therapy Secondary malignant neoplasm of female breast
Item
patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
boolean
C1514460 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Hormone Therapy Neoadjuvant allowed | Prior adjuvant endocrine therapy allowed | NSAID Neoadjuvant Treatment completed | NSAID Adjuvant Treatment completed | Letrozole Treatment completed | Anastrozole Treatment completed
Item
patients may have received prior neoadjuvant or adjuvant endocrine therapy. in the case of neoadjuvant or adjuvant nsai (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0281266 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0580352 (UMLS CUI [3,3])
C0003211 (UMLS CUI [4,1])
C1522673 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
C0246421 (UMLS CUI [5,1])
C0580352 (UMLS CUI [5,2])
C0290883 (UMLS CUI [6,1])
C0580352 (UMLS CUI [6,2])
mTOR Inhibitors
Item
previous treatment with mtor inhibitors.
boolean
C1515672 (UMLS CUI [1])
Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus
Item
known hypersensitivity to mtor inhibitors, e.g., sirolimus (rapamycin).
boolean
C0020517 (UMLS CUI [1,1])
C1515672 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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