ID

38169

Descrição

Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01924078

Link

https://clinicaltrials.gov/show/NCT01924078

Palavras-chave

Versões (1)
  1. 24/09/2019 24/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01924078

Inglês

Eligibility Breast Cancer NCT01924078

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hormone receptor positive;
Descrição

Hormone Receptor Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
2. previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure;
Descrição

Patients Untreated | Hormone Therapy Absent | Hormone Therapy Initial failed | First line Hormone Therapy failed Relapse | First line Hormone Therapy failed Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0205265
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0279025
UMLS CUI [4,3]
C0231175
UMLS CUI [4,4]
C0035020
UMLS CUI [5,1]
C1708063
UMLS CUI [5,2]
C0279025
UMLS CUI [5,3]
C0231175
UMLS CUI [5,4]
C0027627
3. patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery.
Descrição

Hormone Therapy Absent | Invasive Ductal Breast Carcinoma | Operative Surgical Procedures | Elderly | Cardiac complication Severe | Severe medical complication Systemic | High risk of General Anesthesia | Breast Conservation Willing | Large tumor Inappropriate Breast-Conserving Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1134719
UMLS CUI [3]
C0543467
UMLS CUI [4]
C0001792
UMLS CUI [5,1]
C0161816
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C3495031
UMLS CUI [6,2]
C0205373
UMLS CUI [7,1]
C0332167
UMLS CUI [7,2]
C0002915
UMLS CUI [8,1]
C0006141
UMLS CUI [8,2]
C2347858
UMLS CUI [8,3]
C0600109
UMLS CUI [9,1]
C0475278
UMLS CUI [9,2]
C1548788
UMLS CUI [9,3]
C0917927
4. patients with metastatic breast cancer must have evaluable lesions
Descrição

Secondary malignant neoplasm of female breast | Lesions Evaluable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1516986
5. normal laboratory values:
Descrição

Normal Laboratory Test Result

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438214
6. informed consent (ethical approval document no. :1112105-1);
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
7. life expectancy of at least 3 months;
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
8. postmenopausal or premenopausal with bilateral oophorectomy.
Descrição

Postmenopausal state | Premenopausal state | Bilateral oophorectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0232969
UMLS CUI [3]
C0278321
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months
Descrição

Therapeutic radiology procedure | Local Therapy Measurable lesion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C1513041
2. organ transplant (except for autologous or allogeneic bone marrow transplantation);
Descrição

Organ Transplantation | Exception Autologous bone marrow transplant | Exception Allogeneic bone marrow transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0194037
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0149615
3. have evidences of central nerve system metastases or have a history of mental illness that uncontrol;
Descrição

CNS metastases | Mental disorder Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
4. unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity;
Descrição

Lacking Able to swallow Tablets | Malabsorption | Upper Gastrointestinal Tract Integrity Poor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
UMLS CUI [2]
C3714745
UMLS CUI [3,1]
C3203348
UMLS CUI [3,2]
C1947912
UMLS CUI [3,3]
C2700379
5. unwilling or unable to comply with study protocol or unable to meet the follow up;
Descrição

Protocol Compliance Unwilling | Protocol Compliance Unable | Follow-up Fulfill Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1550543
UMLS CUI [3,3]
C1299582
6. patients who researchers considered were not suitable to participate.
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Breast Cancer NCT01924078

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hormone Receptor Positive
Item
1. hormone receptor positive;
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Patients Untreated | Hormone Therapy Absent | Hormone Therapy Initial failed | First line Hormone Therapy failed Relapse | First line Hormone Therapy failed Neoplasm Metastasis
Item
2. previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure;
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0205265 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C1708063 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
C0035020 (UMLS CUI [4,4])
C1708063 (UMLS CUI [5,1])
C0279025 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C0027627 (UMLS CUI [5,4])
Hormone Therapy Absent | Invasive Ductal Breast Carcinoma | Operative Surgical Procedures | Elderly | Cardiac complication Severe | Severe medical complication Systemic | High risk of General Anesthesia | Breast Conservation Willing | Large tumor Inappropriate Breast-Conserving Surgery
Item
3. patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery.
boolean
C0279025 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1134719 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0001792 (UMLS CUI [4])
C0161816 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C3495031 (UMLS CUI [6,1])
C0205373 (UMLS CUI [6,2])
C0332167 (UMLS CUI [7,1])
C0002915 (UMLS CUI [7,2])
C0006141 (UMLS CUI [8,1])
C2347858 (UMLS CUI [8,2])
C0600109 (UMLS CUI [8,3])
C0475278 (UMLS CUI [9,1])
C1548788 (UMLS CUI [9,2])
C0917927 (UMLS CUI [9,3])
Secondary malignant neoplasm of female breast | Lesions Evaluable
Item
4. patients with metastatic breast cancer must have evaluable lesions
boolean
C0346993 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
Normal Laboratory Test Result
Item
5. normal laboratory values:
boolean
C0438214 (UMLS CUI [1])
Informed Consent
Item
6. informed consent (ethical approval document no. :1112105-1);
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of at least 3 months;
boolean
C0023671 (UMLS CUI [1])
Postmenopausal state | Premenopausal state | Bilateral oophorectomy
Item
8. postmenopausal or premenopausal with bilateral oophorectomy.
boolean
C0232970 (UMLS CUI [1])
C0232969 (UMLS CUI [2])
C0278321 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Local Therapy Measurable lesion
Item
1. have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months
boolean
C1522449 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
Organ Transplantation | Exception Autologous bone marrow transplant | Exception Allogeneic bone marrow transplantation
Item
2. organ transplant (except for autologous or allogeneic bone marrow transplantation);
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0194037 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0149615 (UMLS CUI [3,2])
CNS metastases | Mental disorder Uncontrolled
Item
3. have evidences of central nerve system metastases or have a history of mental illness that uncontrol;
boolean
C0686377 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Lacking Able to swallow Tablets | Malabsorption | Upper Gastrointestinal Tract Integrity Poor
Item
4. unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity;
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
C3714745 (UMLS CUI [2])
C3203348 (UMLS CUI [3,1])
C1947912 (UMLS CUI [3,2])
C2700379 (UMLS CUI [3,3])
Protocol Compliance Unwilling | Protocol Compliance Unable | Follow-up Fulfill Unable
Item
5. unwilling or unable to comply with study protocol or unable to meet the follow up;
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Study Subject Participation Status Inappropriate
Item
6. patients who researchers considered were not suitable to participate.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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