ID

26219

Description

Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00684216

Link

https://clinicaltrials.gov/show/NCT00684216

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00684216

English

Eligibility Breast Cancer NCT00684216

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
Description

Invasive carcinoma of breast Distant metastasis | Disease Advanced Locally Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1269798
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C0205187
3. positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). progesterone and her-2 neu receptor have to be known.
Description

Estrogen receptor positive | Nuclei Percentage Positive Immunohistochemistry | Progesterone Known | erbB-2 Receptor Known

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2,1]
C0007610
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1514241
UMLS CUI [2,4]
C0021044
UMLS CUI [3,1]
C0033308
UMLS CUI [3,2]
C0205309
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C0205309
4. - progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. simultaneous use of lh-rh analogs is allowed. or - recurrence of disease (m1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
Description

Progressive Disease | First line Hormone Therapy | Tamoxifen | Aromatase Inhibitors | Neoplasm Metastasis | Disease Advanced Locally Inoperable | LH-RH Agonist allowed | Recurrent disease | Hormone Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0279025
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0593802
UMLS CUI [5]
C0027627
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205179
UMLS CUI [6,3]
C1517927
UMLS CUI [6,4]
C0205187
UMLS CUI [7,1]
C1518041
UMLS CUI [7,2]
C0683607
UMLS CUI [8]
C0277556
UMLS CUI [9,1]
C0279025
UMLS CUI [9,2]
C1522673
5. no prior chemotherapy for metastatic disease
Description

Prior Chemotherapy Absent Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027627
6. willing and able to participate in quality of life investigation -
Description

Participation Quality of life Investigation

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C1261322
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
Description

Malignant Neoplasms | Exception Carcinoma in Situ | Exception Curative procedure Malignant Neoplasms | Chemotherapy Absent | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0332197
2. pregnancy or breast feeding women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. contra-indications to the use of capecitabine
Description

Medical contraindication capecitabine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0671970
4. known cns metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
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Similar models

Eligibility Breast Cancer NCT00684216

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Invasive carcinoma of breast Distant metastasis | Disease Advanced Locally Inoperable
Item
2. proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
boolean
C0853879 (UMLS CUI [1,1])
C1269798 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0205187 (UMLS CUI [2,4])
Estrogen receptor positive | Nuclei Percentage Positive Immunohistochemistry | Progesterone Known | erbB-2 Receptor Known
Item
3. positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). progesterone and her-2 neu receptor have to be known.
boolean
C0279754 (UMLS CUI [1])
C0007610 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0021044 (UMLS CUI [2,4])
C0033308 (UMLS CUI [3,1])
C0205309 (UMLS CUI [3,2])
C0069515 (UMLS CUI [4,1])
C0205309 (UMLS CUI [4,2])
Progressive Disease | First line Hormone Therapy | Tamoxifen | Aromatase Inhibitors | Neoplasm Metastasis | Disease Advanced Locally Inoperable | LH-RH Agonist allowed | Recurrent disease | Hormone Therapy Adjuvant
Item
4. - progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. simultaneous use of lh-rh analogs is allowed. or - recurrence of disease (m1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
boolean
C1335499 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0039286 (UMLS CUI [3])
C0593802 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0205179 (UMLS CUI [6,2])
C1517927 (UMLS CUI [6,3])
C0205187 (UMLS CUI [6,4])
C1518041 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C0277556 (UMLS CUI [8])
C0279025 (UMLS CUI [9,1])
C1522673 (UMLS CUI [9,2])
Prior Chemotherapy Absent Neoplasm Metastasis
Item
5. no prior chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Participation Quality of life Investigation
Item
6. willing and able to participate in quality of life investigation -
boolean
C0679823 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Carcinoma in Situ | Exception Curative procedure Malignant Neoplasms | Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
1. other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
2. pregnancy or breast feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication capecitabine
Item
3. contra-indications to the use of capecitabine
boolean
C1301624 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
CNS metastases
Item
4. known cns metastases
boolean
C0686377 (UMLS CUI [1])
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