ID

26741

Description

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00880009

Link

https://clinicaltrials.gov/show/NCT00880009

Keywords

Versions (1)
  1. 10/23/17 10/23/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00880009

English

Eligibility Breast Cancer NCT00880009

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
surgically sterile or post-menopausal women.
Description

Female Sterilization | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
confirmed pathologic diagnosis of breast cancer.
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Breast cancer recurrent Local-Regional | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C0278493
UMLS CUI [3,2]
C1947913
UMLS CUI [4,1]
C1511562
UMLS CUI [4,2]
C1272705
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C1276305
UMLS CUI [5,3]
C1272705
documented er+ and/or pgr+ and erbb2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
Description

Estrogen receptor positive tumor Biopsy | Progesterone receptor positive tumor Biopsy | Neoplasm HER2/Neu Negative Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1562312
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1562928
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C2348908
UMLS CUI [3,3]
C0005558
at least 1 radiologically measurable lesion as defined by response evaluation criteria in solid tumors (recist).
Description

Measurable lesion Quantity Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0043299
eastern cooperative oncology group (ecog) performance status 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior src inhibitor.
Description

letrozole | Exception Adjuvant therapy | bosutinib | src inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0246421
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677850
UMLS CUI [3]
C1831731
UMLS CUI [4,1]
C0282625
UMLS CUI [4,2]
C0243077
prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant aromatase inhibitor (ai) agent/regimen is permitted).
Description

Hormone Therapy Locally advanced breast cancer | Hormone Therapy Secondary malignant neoplasm of female breast | Aromatase Inhibitors Adjuvant Quantity allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C3495949
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0346993
UMLS CUI [3,1]
C0593802
UMLS CUI [3,2]
C1522673
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0683607
more than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.
Description

Chemotherapy Regimen Quantity Locally advanced breast cancer | Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3495949
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0346993
adjuvant endocrine therapy <=12 months prior to day 1 of treatment.
Description

Hormone Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
disease refractory (ie, progressive disease (pd) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
Description

Prior antiestrogen therapy Adjuvant | Refractory Disease | Progressive Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0279797
UMLS CUI [1,2]
C1522673
UMLS CUI [2]
C1514815
UMLS CUI [3]
C1335499
bone or skin as the only site of disease.
Description

Disorder by Site Bone only | Disorder by Site Skin only

Data type

boolean

Alias
UMLS CUI [1,1]
C1333305
UMLS CUI [1,2]
C0262950
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C1333305
UMLS CUI [2,2]
C1123023
UMLS CUI [2,3]
C0205171
extensive visceral disease or active central nervous system (cns) disease.
Description

Disease Visceral Extensive | CNS disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C0205231
UMLS CUI [2]
C0007682
any other cancer within 5 years of screening with the exception of er+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
Description

Cancer Other | Exception Contralateral Breast Carcinoma Estrogen receptor positive | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3274709
UMLS CUI [2,3]
C0279754
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
major surgery or radiotherapy within 14 days of treatment day.
Description

Major surgery | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
inadequate hepatic/renal/bone marrow function.
Description

Liver Dysfunction | Abnormal renal function | Bone Marrow function Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [3,3]
C0205412
history of clinically significant or uncontrolled cardiac disease.
Description

Heart Disease Clinical Significance | Heart Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
serious concurrent illness.
Description

Comorbidity Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
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Similar models

Eligibility Breast Cancer NCT00880009

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Female Sterilization | Postmenopausal state
Item
surgically sterile or post-menopausal women.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Breast Carcinoma
Item
confirmed pathologic diagnosis of breast cancer.
boolean
C0678222 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Breast cancer recurrent Local-Regional | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful
Item
locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0278493 (UMLS CUI [3,1])
C1947913 (UMLS CUI [3,2])
C1511562 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C1276305 (UMLS CUI [5,2])
C1272705 (UMLS CUI [5,3])
Estrogen receptor positive tumor Biopsy | Progesterone receptor positive tumor Biopsy | Neoplasm HER2/Neu Negative Biopsy
Item
documented er+ and/or pgr+ and erbb2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
boolean
C1562312 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1562928 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C2348908 (UMLS CUI [3,2])
C0005558 (UMLS CUI [3,3])
Measurable lesion Quantity Radiography
Item
at least 1 radiologically measurable lesion as defined by response evaluation criteria in solid tumors (recist).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0043299 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
letrozole | Exception Adjuvant therapy | bosutinib | src inhibitors
Item
prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior src inhibitor.
boolean
C0246421 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1831731 (UMLS CUI [3])
C0282625 (UMLS CUI [4,1])
C0243077 (UMLS CUI [4,2])
Hormone Therapy Locally advanced breast cancer | Hormone Therapy Secondary malignant neoplasm of female breast | Aromatase Inhibitors Adjuvant Quantity allowed
Item
prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant aromatase inhibitor (ai) agent/regimen is permitted).
boolean
C0279025 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0593802 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
Chemotherapy Regimen Quantity Locally advanced breast cancer | Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast
Item
more than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495949 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0346993 (UMLS CUI [2,3])
Hormone Therapy Adjuvant
Item
adjuvant endocrine therapy <=12 months prior to day 1 of treatment.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Prior antiestrogen therapy Adjuvant | Refractory Disease | Progressive Disease
Item
disease refractory (ie, progressive disease (pd) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
boolean
C0279797 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
Disorder by Site Bone only | Disorder by Site Skin only
Item
bone or skin as the only site of disease.
boolean
C1333305 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C1333305 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Disease Visceral Extensive | CNS disorder
Item
extensive visceral disease or active central nervous system (cns) disease.
boolean
C0012634 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C0007682 (UMLS CUI [2])
Cancer Other | Exception Contralateral Breast Carcinoma Estrogen receptor positive | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
any other cancer within 5 years of screening with the exception of er+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3274709 (UMLS CUI [2,2])
C0279754 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiotherapy within 14 days of treatment day.
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Liver Dysfunction | Abnormal renal function | Bone Marrow function Inadequate
Item
inadequate hepatic/renal/bone marrow function.
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Heart Disease Clinical Significance | Heart Disease Uncontrolled
Item
history of clinically significant or uncontrolled cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Comorbidity Serious
Item
serious concurrent illness.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
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