ID

24609

Descrição

PTC299 and Hormonal Agent for Treatment of Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00508586

Link

https://clinicaltrials.gov/show/NCT00508586

Palavras-chave

Versões (1)
  1. 08/08/2017 08/08/2017 -
Transferido a

8 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00508586

Inglês

Eligibility Metastatic Breast Cancer NCT00508586

1 Formulários  
Criteria
Descrição

Criteria

1. female sex.
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
2. age ≥18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. body weight 40-100 kg.
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
4. ecog performance status of 0 or 1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
5. histologically or cytologically confirmed adenocarcinoma of the breast.
Descrição

Breast adenocarcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0858252
6. presence of metastatic disease not amenable to surgery, radiation therapy, or chemoradiotherapy with curative intent.
Descrição

Neoplasm Metastasis | Operative Surgical Procedure Curative Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful | Chemoradiotherapy Curative Unsuccessful

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1276305
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C1272705
UMLS CUI [4,1]
C0436307
UMLS CUI [4,2]
C1276305
UMLS CUI [4,3]
C1272705
7. no active second metastatic malignancy other than breast cancer.
Descrição

Exclusion Criteria | Neoplasm Metastasis second | Malignant neoplasm of breast Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0006142
UMLS CUI [3,2]
C2828389
8. no unstable brain or leptomeningeal disease.
Descrição

Exclusion Criteria | Brain Disease Unstable | Leptomeningeal disease Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0006111
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0751297
UMLS CUI [3,2]
C0443343
9. discontinuation of other therapies (except for anastrozole, letrozole, or exemestane) for the treatment of breast cancer and resolution of any acute toxic effects of prior therapies.
Descrição

Drug therapy discontinued Breast Carcinoma | Exception anastrozole | Exception letrozole | Exception exemestane | Prior Therapy Toxic effect Resolution

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0290883
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0246421
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851344
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C0600688
UMLS CUI [5,3]
C1514893
10. adequate bone marrow, liver, and kidney function.
Descrição

Bone Marrow function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
11. no uncontrolled hypertension, major bleeding, hiv infection or recent acute cardiovascular event.
Descrição

Exclusion Criteria | Uncontrolled hypertension | Hemorrhage Major | HIV Infection | Cardiovascular event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C0205164
UMLS CUI [4]
C0019693
UMLS CUI [5]
C1320716
12. if sexually active and not postmenopausal or surgically sterile, willingness to abstain from sexual intercourse or employ an effective barrier method of contraception during the study drug administration and follow-up periods.
Descrição

Sexually active | Postmenopausal state Absent | Female Sterilization Absent | Sexual Abstinence Willing | Barrier Contraception Usage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0241028
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0036899
UMLS CUI [4,2]
C0600109
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0457083
13. no pregnancy or breast-feeding.
Descrição

Exclusion Criteria | Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
14. willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
15. willingness to provide informed consent. in addition to the criteria noted above, stage 2 subjects must also have natural or induced suppression of ovarian function to post-menopausal levels and be receiving or be a candidate for hormonal therapy.
Descrição

Informed Consent | TNM clinical staging Ovarian suppression Level Postmenopausal | Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C0677922
UMLS CUI [2,3]
C0441889
UMLS CUI [2,4]
C0232970
UMLS CUI [3]
C0279025
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Similar models

Eligibility Metastatic Breast Cancer NCT00508586

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Gender
Item
1. female sex.
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
3. body weight 40-100 kg.
boolean
C0005910 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Breast adenocarcinoma
Item
5. histologically or cytologically confirmed adenocarcinoma of the breast.
boolean
C0858252 (UMLS CUI [1])
Neoplasm Metastasis | Operative Surgical Procedure Curative Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful | Chemoradiotherapy Curative Unsuccessful
Item
6. presence of metastatic disease not amenable to surgery, radiation therapy, or chemoradiotherapy with curative intent.
boolean
C0027627 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C0436307 (UMLS CUI [4,1])
C1276305 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
Exclusion Criteria | Neoplasm Metastasis second | Malignant neoplasm of breast Excluded
Item
7. no active second metastatic malignancy other than breast cancer.
boolean
C0680251 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0006142 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Exclusion Criteria | Brain Disease Unstable | Leptomeningeal disease Unstable
Item
8. no unstable brain or leptomeningeal disease.
boolean
C0680251 (UMLS CUI [1])
C0006111 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0751297 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Drug therapy discontinued Breast Carcinoma | Exception anastrozole | Exception letrozole | Exception exemestane | Prior Therapy Toxic effect Resolution
Item
9. discontinuation of other therapies (except for anastrozole, letrozole, or exemestane) for the treatment of breast cancer and resolution of any acute toxic effects of prior therapies.
boolean
C0558681 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0290883 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0246421 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851344 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0600688 (UMLS CUI [5,2])
C1514893 (UMLS CUI [5,3])
Bone Marrow function | Liver function | Renal function
Item
10. adequate bone marrow, liver, and kidney function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Exclusion Criteria | Uncontrolled hypertension | Hemorrhage Major | HIV Infection | Cardiovascular event
Item
11. no uncontrolled hypertension, major bleeding, hiv infection or recent acute cardiovascular event.
boolean
C0680251 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0019080 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
C1320716 (UMLS CUI [5])
Sexually active | Postmenopausal state Absent | Female Sterilization Absent | Sexual Abstinence Willing | Barrier Contraception Usage
Item
12. if sexually active and not postmenopausal or surgically sterile, willingness to abstain from sexual intercourse or employ an effective barrier method of contraception during the study drug administration and follow-up periods.
boolean
C0241028 (UMLS CUI [1])
C0232970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4,1])
C0600109 (UMLS CUI [4,2])
C0004764 (UMLS CUI [5,1])
C0457083 (UMLS CUI [5,2])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
13. no pregnancy or breast-feeding.
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Protocol Compliance
Item
14. willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
boolean
C0525058 (UMLS CUI [1])
Informed Consent | TNM clinical staging Ovarian suppression Level Postmenopausal | Hormone Therapy
Item
15. willingness to provide informed consent. in addition to the criteria noted above, stage 2 subjects must also have natural or induced suppression of ovarian function to post-menopausal levels and be receiving or be a candidate for hormonal therapy.
boolean
C0021430 (UMLS CUI [1])
C3258246 (UMLS CUI [2,1])
C0677922 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0232970 (UMLS CUI [2,4])
C0279025 (UMLS CUI [3])
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