ID

38325

Description

A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064); ODM derived from: https://clinicaltrials.gov/show/NCT01605396

Link

https://clinicaltrials.gov/show/NCT01605396

Keywords

Versions (1)
  1. 10/10/19 10/10/19 -
Copyright Holder

See clinicaltrials.gov

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October 10, 2019

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01605396

English

Eligibility Breast Neoplasms NCT01605396

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to
Description

Secondary malignant neoplasm of female breast | Locally advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C3495949
surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and human epidermal growth factor receptor 2 (her-2) negative, and ki67 (a tumor marker) ≥ 15% determined by the central study laboratory
Description

Locally advanced breast cancer Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative | Disease characteristic | Estrogen receptor positive | HER2 Negative | Ki67 Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1511562
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C1276305
UMLS CUI [3]
C0599878
UMLS CUI [4]
C0279754
UMLS CUI [5]
C2348908
UMLS CUI [6]
C4049944
post-menopausal
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
with advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
Description

Advanced breast cancer | Unresponsive to Letrozole | Unresponsive to Anastrozole

Data type

boolean

Alias
UMLS CUI [1]
C3495917
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0246421
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C0290883
has at least one confirmed measurable metastatic lesion
Description

Metastatic Lesion Measurable Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
has a performance status ≤ 1 on the eastern cooperative oncology group (ecog) performance scale
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
has a life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is receiving any other concurrent systemic tumor therapy, including
Description

Cancer treatment Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
hormonal agents and her-2 inhibitors
Description

Antineoplastic Agents, Hormonal | HER2 Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0282559
UMLS CUI [2]
C2916795
previously received rapamycin or rapamycin analogs, including
Description

Sirolimus | Sirolimus Analog

Data type

boolean

Alias
UMLS CUI [1]
C0072980
UMLS CUI [2,1]
C0072980
UMLS CUI [2,2]
C0243071
ridaforolimus, temsirolimus, or everolimus
Description

ridaforolimus | temsirolimus | everolimus

Data type

boolean

Alias
UMLS CUI [1]
C2713007
UMLS CUI [2]
C1707080
UMLS CUI [3]
C0541315
received prior treatment with insulin-like growth factor 1 receptor (igf-1r) inhibitors, phosphatidylinositol 3-kinase (pi3k) inhibitors, or
Description

IGF1R inhibitors | Phosphatidylinositide 3-Kinase Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C4044495
UMLS CUI [1,2]
C0243077
UMLS CUI [2]
C1519050
other experimental agents that target pi3k, protein kinase b (akt), or mammalian target of rapamycin (mtor) pathway
Description

Investigational New Drugs Targeting PI3K | Investigational New Drugs Targeting AKT | Investigational New Drugs Targeting MTOR

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0044602
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0812228
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C1414805
is receiving chronic corticosteroids administered at doses greater than
Description

Adrenal Cortex Hormones High dose chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C0205191
those used for normal replacement therapy
Description

ID.16

Data type

boolean

has active brain metastasis or leptomeningeal carcinomatosis; patients
Description

Metastatic malignant neoplasm to brain | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0220654
with adequately treated brain metastases are eligible if they meet certain criteria
Description

Metastatic malignant neoplasm to brain Treated Eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C1548635
known allergy to macrolide antibiotics
Description

Allergy to macrolide antibiotic

Data type

boolean

Alias
UMLS CUI [1]
C0571383
has an active infection requiring antibiotics
Description

Communicable Disease Requirement Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
significant or uncontrolled cardiovascular disease
Description

Cardiovascular Disease Significant | Cardiovascular Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205318
poorly controlled type 1 or 2 diabetes
Description

Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
is known to be human immunodeficiency virus (hiv) positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
has a known history of active hepatitis b or c. healthy carriers of hepatitis b are not allowed on this study
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Similar models

Eligibility Breast Neoplasms NCT01605396

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast | Locally advanced breast cancer
Item
females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to
boolean
C0346993 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
Locally advanced breast cancer Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative | Disease characteristic | Estrogen receptor positive | HER2 Negative | Ki67 Measurement
Item
surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and human epidermal growth factor receptor 2 (her-2) negative, and ki67 (a tumor marker) ≥ 15% determined by the central study laboratory
boolean
C3495949 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
C3495949 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
C0599878 (UMLS CUI [3])
C0279754 (UMLS CUI [4])
C2348908 (UMLS CUI [5])
C4049944 (UMLS CUI [6])
Postmenopausal state
Item
post-menopausal
boolean
C0232970 (UMLS CUI [1])
Advanced breast cancer | Unresponsive to Letrozole | Unresponsive to Anastrozole
Item
with advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
boolean
C3495917 (UMLS CUI [1])
C0205269 (UMLS CUI [2,1])
C0246421 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3,1])
C0290883 (UMLS CUI [3,2])
Metastatic Lesion Measurable Quantity
Item
has at least one confirmed measurable metastatic lesion
boolean
C1513183 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
has a performance status ≤ 1 on the eastern cooperative oncology group (ecog) performance scale
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
has a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic
Item
is receiving any other concurrent systemic tumor therapy, including
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Antineoplastic Agents, Hormonal | HER2 Antagonists
Item
hormonal agents and her-2 inhibitors
boolean
C0282559 (UMLS CUI [1])
C2916795 (UMLS CUI [2])
Sirolimus | Sirolimus Analog
Item
previously received rapamycin or rapamycin analogs, including
boolean
C0072980 (UMLS CUI [1])
C0072980 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
ridaforolimus | temsirolimus | everolimus
Item
ridaforolimus, temsirolimus, or everolimus
boolean
C2713007 (UMLS CUI [1])
C1707080 (UMLS CUI [2])
C0541315 (UMLS CUI [3])
IGF1R inhibitors | Phosphatidylinositide 3-Kinase Inhibitor
Item
received prior treatment with insulin-like growth factor 1 receptor (igf-1r) inhibitors, phosphatidylinositol 3-kinase (pi3k) inhibitors, or
boolean
C4044495 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
C1519050 (UMLS CUI [2])
Investigational New Drugs Targeting PI3K | Investigational New Drugs Targeting AKT | Investigational New Drugs Targeting MTOR
Item
other experimental agents that target pi3k, protein kinase b (akt), or mammalian target of rapamycin (mtor) pathway
boolean
C0013230 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0044602 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0812228 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C1414805 (UMLS CUI [3,3])
Adrenal Cortex Hormones High dose chronic
Item
is receiving chronic corticosteroids administered at doses greater than
boolean
C0001617 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
ID.16
Item
those used for normal replacement therapy
boolean
Metastatic malignant neoplasm to brain | Meningeal Carcinomatosis
Item
has active brain metastasis or leptomeningeal carcinomatosis; patients
boolean
C0220650 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Treated Eligible
Item
with adequately treated brain metastases are eligible if they meet certain criteria
boolean
C0220650 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
Allergy to macrolide antibiotic
Item
known allergy to macrolide antibiotics
boolean
C0571383 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics
Item
has an active infection requiring antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Cardiovascular Disease Significant | Cardiovascular Disease Uncontrolled
Item
significant or uncontrolled cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
poorly controlled type 1 or 2 diabetes
boolean
C0011854 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
HIV Seropositivity
Item
is known to be human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
has a known history of active hepatitis b or c. healthy carriers of hepatitis b are not allowed on this study
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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