ID

14790

Description

Study of SRN-927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02316509

Link

https://clinicaltrials.gov/show/NCT02316509

Keywords

Versions (1)
  1. 4/28/16 4/28/16 -
Uploaded on

April 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02316509

English

Eligibility Breast Cancer NCT02316509

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for er+ breast cancer
Description

Breast adenocarcinoma | Recurrent disease | Excision | Therapeutic radiology procedure | Neoplasm Metastasis | Hormone Therapy Estrogen receptor positive Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C0277556
UMLS CUI [3]
C0728940
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0027627
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C0279754
UMLS CUI [6,3]
C0678222
er-positive, her2-negative
Description

Estrogen receptor positive status [ER+] | Human epidermal growth factor 2 negative carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C1719706
UMLS CUI [2]
C2316304
no prior treatment with arn-810 (allowed only during dose expansion stage)
Description

Prior Therapy Selective Estrogen Receptor Degrader ARN-810

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3827161
no more than 2 prior chemotherapies in the advanced or metastatic setting
Description

prior chemotherapy for advanced disease | Prior Chemotherapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0278940
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0027627
at least 2 months must have elapsed from the use of tamoxifen
Description

Tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C0039286
at least 6 months must have elapsed from the use of fulvestrant
Description

fulvestrant

Data type

boolean

Alias
UMLS CUI [1]
C0935916
at least 2 weeks must have elapsed from the use of any other anti-cancer hormonal therapy
Description

cancer treatment Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0279025
at least 3 weeks must have elapsed from the use of any chemotherapy
Description

Chemotherapy Regimen

Data type

boolean

Alias
UMLS CUI [1]
C0392920
females, 18 years of age or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
postmenopausal status as defined by the protocol
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
eastern cooperative oncology group (ecog) performance status </= 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function
Description

body system or organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
untreated or symptomatic brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
Description

Systemic cancer treatment Advanced disease | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0679246
UMLS CUI [2]
C0949266
any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of grade >/= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident including transient ischemic attack
Description

Myocardial Infarction | Angina Pectoris | Angina, Unstable | Cardiac Arrhythmia | Atrial Fibrillation | Coronary Artery Bypass Surgery | Congestive heart failure Symptomatic | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0010055
UMLS CUI [7,1]
C0018802
UMLS CUI [7,2]
C0231220
UMLS CUI [8]
C0038454
UMLS CUI [9]
C0007787
active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
Description

Inflammatory Bowel Diseases | Chronic diarrhea | Short Bowel Syndrome | Upper gastrointestinal surgery | Gastrectomy

Data type

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0401151
UMLS CUI [3]
C0036992
UMLS CUI [4]
C1319412
UMLS CUI [5]
C0017118
known human immunodeficiency virus infection
Description

HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0019693
major surgery within 4 weeks prior to enrollment
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
radiation therapy within 2 weeks prior to enrollment
Description

radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Breast Cancer NCT02316509

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | Recurrent disease | Excision | Therapeutic radiology procedure | Neoplasm Metastasis | Hormone Therapy Estrogen receptor positive Breast Carcinoma
Item
histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for er+ breast cancer
boolean
C0858252 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0728940 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
C0279025 (UMLS CUI [6,1])
C0279754 (UMLS CUI [6,2])
C0678222 (UMLS CUI [6,3])
Estrogen receptor positive status [ER+] | Human epidermal growth factor 2 negative carcinoma of breast
Item
er-positive, her2-negative
boolean
C1719706 (UMLS CUI [1])
C2316304 (UMLS CUI [2])
Prior Therapy Selective Estrogen Receptor Degrader ARN-810
Item
no prior treatment with arn-810 (allowed only during dose expansion stage)
boolean
C1514463 (UMLS CUI [1,1])
C3827161 (UMLS CUI [1,2])
prior chemotherapy for advanced disease | Prior Chemotherapy Neoplasm Metastasis
Item
no more than 2 prior chemotherapies in the advanced or metastatic setting
boolean
C0278940 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Tamoxifen
Item
at least 2 months must have elapsed from the use of tamoxifen
boolean
C0039286 (UMLS CUI [1])
fulvestrant
Item
at least 6 months must have elapsed from the use of fulvestrant
boolean
C0935916 (UMLS CUI [1])
cancer treatment Hormone Therapy
Item
at least 2 weeks must have elapsed from the use of any other anti-cancer hormonal therapy
boolean
C0920425 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Chemotherapy Regimen
Item
at least 3 weeks must have elapsed from the use of any chemotherapy
boolean
C0392920 (UMLS CUI [1])
Gender | Age
Item
females, 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal state
Item
postmenopausal status as defined by the protocol
boolean
C0232970 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status </= 2
boolean
C1520224 (UMLS CUI [1])
body system or organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
untreated or symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1])
Systemic cancer treatment Advanced disease | Therapies, Investigational
Item
current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2])
Myocardial Infarction | Angina Pectoris | Angina, Unstable | Cardiac Arrhythmia | Atrial Fibrillation | Coronary Artery Bypass Surgery | Congestive heart failure Symptomatic | Cerebrovascular accident | Transient Ischemic Attack
Item
any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of grade >/= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident including transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0018802 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0038454 (UMLS CUI [8])
C0007787 (UMLS CUI [9])
Inflammatory Bowel Diseases | Chronic diarrhea | Short Bowel Syndrome | Upper gastrointestinal surgery | Gastrectomy
Item
active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
boolean
C0021390 (UMLS CUI [1])
C0401151 (UMLS CUI [2])
C0036992 (UMLS CUI [3])
C1319412 (UMLS CUI [4])
C0017118 (UMLS CUI [5])
HIV Infections
Item
known human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
major surgery
Item
major surgery within 4 weeks prior to enrollment
boolean
C0679637 (UMLS CUI [1])
radiation therapy
Item
radiation therapy within 2 weeks prior to enrollment
boolean
C1522449 (UMLS CUI [1])
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