ID

25970

Description

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

Lien

https://clinicaltrials.gov/show/NCT01611727

Mots-clés

Versions (2)
  1. 02/10/2017 02/10/2017 -
  2. 04/10/2017 04/10/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

2 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Eligibility BRCA1 Mutation NCT01611727

Anglais

Eligibility BRCA1 Mutation NCT01611727

1 Formulaires  
Inclusion Criteria
Description

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.
Description

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

Type de données

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:
Description

Criteria Fulfill

Type de données

boolean

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

Hematologic function

Type de données

boolean

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

Renal function | Liver function

Type de données

boolean

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

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

Type de données

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)
Description

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

Type de données

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
Description

Life Expectancy

Type de données

boolean

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

ECOG performance status

Type de données

boolean

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

Chemotherapy Quantity Neoplasm Metastasis

Type de données

boolean

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

Exclusion Criteria

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

Metastatic malignant neoplasm to brain

Type de données

boolean

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

Chemotherapy Platinum Based

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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