Informationen:
Fehler:
ID
14790
Beschreibung
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
Stichworte
Versionen (1)
- 28.04.16 28.04.16 -
Hochgeladen am
28. April 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02316509
Eligibility Breast Cancer NCT02316509
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Breast Cancer NCT02316509
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])