ID

25970

Descripción

Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01611727

Link

https://clinicaltrials.gov/show/NCT01611727

Palabras clave

Versiones (2)
  1. 2/10/17 2/10/17 -
  2. 4/10/17 4/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de octubre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility BRCA1 Mutation NCT01611727

Inglés

Eligibility BRCA1 Mutation NCT01611727

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients aged ≥ 18 years, with measurable (defined by response evaluation criteria in solid tumors (recist) criteria (14)) metastatic (stage iv) breast cancer, and who are known to carry a brca1 mutation, are eligible.
Descripción

Gender | Age | Secondary malignant neoplasm of female breast Measurable | BRCA1 Mutation Carrier

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0346993
UMLS CUI [3,2]
C1513040
UMLS CUI [4]
C3899965
in addition, the following are required:
Descripción

Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
adequate hematologic
Descripción

Hematologic function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
renal, and hepatic function
Descripción

Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
adequate recovery from recent surgery and/or radiation therapy
Descripción

Operative Surgical Procedures Recent Patient recovered | Therapeutic radiology procedure Recent Patient recovered

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C1115804
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C1115804
recovery from all prior treatment-related toxicities (to grade < 2 according to national cancer institute common toxicity criteria, version3.0, except alopecia)
Descripción

Toxicity Due to Therapeutic procedure CTCAE Grades | Patient recovered | Exception Alopecia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1516728
UMLS CUI [2]
C1115804
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
life expectancy of at least 12 weeks
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status of 0 or 1. -
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
patients could have received up to four prior chemotherapies for metastatic disease.
Descripción

Chemotherapy Quantity Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known brain metastases are not eligible.
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
patients previously treated with a platinum-based chemotherapy are not eligible.
Descripción

Chemotherapy Platinum Based

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0032207
UMLS CUI [1,3]
C1705938
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Similar models

Eligibility BRCA1 Mutation NCT01611727

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Secondary malignant neoplasm of female breast Measurable | BRCA1 Mutation Carrier
Item
female patients aged ≥ 18 years, with measurable (defined by response evaluation criteria in solid tumors (recist) criteria (14)) metastatic (stage iv) breast cancer, and who are known to carry a brca1 mutation, are eligible.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0346993 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C3899965 (UMLS CUI [4])
Criteria Fulfill
Item
in addition, the following are required:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Hematologic function
Item
adequate hematologic
boolean
C0221130 (UMLS CUI [1])
Renal function | Liver function
Item
renal, and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Operative Surgical Procedures Recent Patient recovered | Therapeutic radiology procedure Recent Patient recovered
Item
adequate recovery from recent surgery and/or radiation therapy
boolean
C0543467 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Toxicity Due to Therapeutic procedure CTCAE Grades | Patient recovered | Exception Alopecia
Item
recovery from all prior treatment-related toxicities (to grade < 2 according to national cancer institute common toxicity criteria, version3.0, except alopecia)
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C1115804 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1. -
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Quantity Neoplasm Metastasis
Item
patients could have received up to four prior chemotherapies for metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
patients with known brain metastases are not eligible.
boolean
C0220650 (UMLS CUI [1])
Chemotherapy Platinum Based
Item
patients previously treated with a platinum-based chemotherapy are not eligible.
boolean
C0392920 (UMLS CUI [1,1])
C0032207 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
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