ID

26009

Description

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

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility BRCA1 Mutation NCT01611727

English

Eligibility BRCA1 Mutation NCT01611727

1 forms  
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

Data type

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

Data type

boolean

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

Hematologic function

Data type

boolean

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

Renal function | Liver function

Data type

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

Data type

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

Data type

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

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Chemotherapy Quantity Neoplasm Metastasis

Data type

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

Data type

boolean

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

Chemotherapy Platinum Based

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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