ID

30593

Description

Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic; ODM derived from: https://clinicaltrials.gov/show/NCT00696072

Link

https://clinicaltrials.gov/show/NCT00696072

Keywords

Versions (1)
  1. 6/17/18 6/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00696072

English

Eligibility Metastatic Breast Cancer NCT00696072

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
Description

Breast Carcinoma | Locally Recurrent Malignant Neoplasm unresectable | Neoplasm Metastasis unresectable

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C2986682
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1519810
has measurable or evaluable-only disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
is female, ≥18 yrs of age, post menopausal or surgically sterile
Description

Gender | Age | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
her2 negative, hr+, er+ and/or pgr+ breast cancer
Description

Breast Carcinoma HER2 Negative | Hormone receptor positive malignant neoplasm of breast | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2348908
UMLS CUI [2]
C1562029
UMLS CUI [3]
C2938924
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0279759
0-1 prior chemotherapy regimen for metastatic disease.
Description

Prior Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
Description

Prior adjuvant chemotherapy Completed | Chemotherapy Neoadjuvant Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0281265
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C0205197
prior tamoxifen therapy is allowed
Description

Tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C0039286
no ai therapy for >1 year without recurrence
Description

Aromatase Inhibitors Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior hormonal therapy for metastatic or locally recurrent disease
Description

Prior Hormone Therapy Neoplasm Metastasis | Prior Hormone Therapy Locally Recurrent Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C2986682
>1 chemotherapy regimen for metastatic disease
Description

Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
pleural or pericardial effusion
Description

Pleural effusion | Pericardial effusion

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0031039
serious cardiac condition
Description

Cardiac problem Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0262402
UMLS CUI [1,2]
C0205404
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Similar models

Eligibility Metastatic Breast Cancer NCT00696072

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Locally Recurrent Malignant Neoplasm unresectable | Neoplasm Metastasis unresectable
Item
has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
boolean
C0678222 (UMLS CUI [1])
C2986682 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
Measurable Disease | Evaluable Disease
Item
has measurable or evaluable-only disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Gender | Age | Postmenopausal state | Female Sterilization
Item
is female, ≥18 yrs of age, post menopausal or surgically sterile
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Breast Carcinoma HER2 Negative | Hormone receptor positive malignant neoplasm of breast | Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive
Item
her2 negative, hr+, er+ and/or pgr+ breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C1562029 (UMLS CUI [2])
C2938924 (UMLS CUI [3])
C0678222 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
Prior Chemotherapy Quantity Neoplasm Metastasis
Item
0-1 prior chemotherapy regimen for metastatic disease.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Prior adjuvant chemotherapy Completed | Chemotherapy Neoadjuvant Completed
Item
prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
boolean
C0281265 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Tamoxifen
Item
prior tamoxifen therapy is allowed
boolean
C0039286 (UMLS CUI [1])
Aromatase Inhibitors Absent
Item
no ai therapy for >1 year without recurrence
boolean
C0593802 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Hormone Therapy Neoplasm Metastasis | Prior Hormone Therapy Locally Recurrent Malignant Neoplasm
Item
prior hormonal therapy for metastatic or locally recurrent disease
boolean
C1514460 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C2986682 (UMLS CUI [2,2])
Chemotherapy Quantity Neoplasm Metastasis
Item
>1 chemotherapy regimen for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Pleural effusion | Pericardial effusion
Item
pleural or pericardial effusion
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
Cardiac problem Serious
Item
serious cardiac condition
boolean
C0262402 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
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