ID

38022

Beschreibung

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01437566

Link

https://clinicaltrials.gov/show/NCT01437566

Stichworte

Versionen (1)
  1. 09.09.19 09.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. September 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01437566

Englisch

Eligibility Breast Cancer NCT01437566

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with er-positive locally advanced breast cancer or metastatic breast cancer (mbc). postmenopausal women with locally advanced breast cancer or metastatic breast cancer whose disease has progressed during or after treatment with an aromatase inhibitor. part ii: postmenopausal women with locally advanced pik3ca-mutant breast cancer or pik3ca-mutant mbc that has progressed during or after treatment with an ai.
Beschreibung

Locally advanced breast cancer Estrogen receptor positive | Secondary malignant neoplasm of female breast Estrogen receptor positive | Postmenopausal state | Disease Progression | Aromatase Inhibitors | Locally advanced breast cancer PIK3CA Gene Mutation | Secondary malignant neoplasm of female breast PIK3CA Gene Mutation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0279754
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0242656
UMLS CUI [5]
C0593802
UMLS CUI [6,1]
C3495949
UMLS CUI [6,2]
C3272694
UMLS CUI [7,1]
C0346993
UMLS CUI [7,2]
C3272694
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients must have measurable disease by recist v1.1 or bone-only disease
Beschreibung

Measurable Disease | Bone Disease only

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0005940
UMLS CUI [2,2]
C0205171
adequate hematologic and end-organ function
Beschreibung

Hematologic function | Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
estrogen receptor-positive disease and her2-negative disease
Beschreibung

Disease Estrogen receptor positive | Disease HER2 Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348908
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with fulvestrant, pi3k inhibitor, or mtor inhibitor for advanced breast cancer or mbc
Beschreibung

Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | fulvestrant | PI3K Inhibitor | mTOR Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3495917
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0346993
UMLS CUI [3]
C0935916
UMLS CUI [4]
C1519050
UMLS CUI [5]
C1515672
prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
Beschreibung

Cytotoxic Chemotherapy Quantity | Recurrent disease | Progressive Disease | Hormone Therapy Quantity Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0346993
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Beschreibung

Malabsorption Syndrome | Condition Interferes with Absorption Enteral

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
history of clinically significant cardiac or pulmonary dysfunction
Beschreibung

Cardiac dysfunction | Pulmonary Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
clinically significant history of liver disease
Beschreibung

Liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
active uncontrolled autoimmune disease or active inflammatory disease
Beschreibung

Autoimmune Disease Uncontrolled | Inflammatory disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1290884
immunocompromised status
Beschreibung

Immunocompromised patient

Datentyp

boolean

Alias
UMLS CUI [1]
C0085393
symptomatic hypercalcemia
Beschreibung

Hypercalcemia Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0231220
need for current chronic corticosteroid therapy
Beschreibung

Patient need for Steroid therapy chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0149783
UMLS CUI [1,3]
C0205191
pregnancy, lactation, or breastfeeding
Beschreibung

Pregnancy | Lactation | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
known untreated or active central nervous system (cns) metastases other protocol-defined inclusion/exclusion criteria may apply.
Beschreibung

CNS metastases Untreated | CNS metastases | Eligibility Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0686377
UMLS CUI [3,1]
C1516637
UMLS CUI [3,2]
C1524062
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Ähnliche Modelle

Eligibility Breast Cancer NCT01437566

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer Estrogen receptor positive | Secondary malignant neoplasm of female breast Estrogen receptor positive | Postmenopausal state | Disease Progression | Aromatase Inhibitors | Locally advanced breast cancer PIK3CA Gene Mutation | Secondary malignant neoplasm of female breast PIK3CA Gene Mutation
Item
patients with er-positive locally advanced breast cancer or metastatic breast cancer (mbc). postmenopausal women with locally advanced breast cancer or metastatic breast cancer whose disease has progressed during or after treatment with an aromatase inhibitor. part ii: postmenopausal women with locally advanced pik3ca-mutant breast cancer or pik3ca-mutant mbc that has progressed during or after treatment with an ai.
boolean
C3495949 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
C3495949 (UMLS CUI [6,1])
C3272694 (UMLS CUI [6,2])
C0346993 (UMLS CUI [7,1])
C3272694 (UMLS CUI [7,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease | Bone Disease only
Item
patients must have measurable disease by recist v1.1 or bone-only disease
boolean
C1513041 (UMLS CUI [1])
C0005940 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Hematologic function | Organ function
Item
adequate hematologic and end-organ function
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Disease Estrogen receptor positive | Disease HER2 Negative
Item
estrogen receptor-positive disease and her2-negative disease
boolean
C0012634 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | fulvestrant | PI3K Inhibitor | mTOR Inhibitors
Item
prior treatment with fulvestrant, pi3k inhibitor, or mtor inhibitor for advanced breast cancer or mbc
boolean
C1514463 (UMLS CUI [1,1])
C3495917 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0935916 (UMLS CUI [3])
C1519050 (UMLS CUI [4])
C1515672 (UMLS CUI [5])
Cytotoxic Chemotherapy Quantity | Recurrent disease | Progressive Disease | Hormone Therapy Quantity Secondary malignant neoplasm of female breast
Item
prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0346993 (UMLS CUI [4,3])
Malabsorption Syndrome | Condition Interferes with Absorption Enteral
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Autoimmune Disease Uncontrolled | Inflammatory disorder
Item
active uncontrolled autoimmune disease or active inflammatory disease
boolean
C0004364 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2])
Immunocompromised patient
Item
immunocompromised status
boolean
C0085393 (UMLS CUI [1])
Hypercalcemia Symptomatic
Item
symptomatic hypercalcemia
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient need for Steroid therapy chronic
Item
need for current chronic corticosteroid therapy
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
CNS metastases Untreated | CNS metastases | Eligibility Criteria Additional
Item
known untreated or active central nervous system (cns) metastases other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
C1516637 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
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