ID

38341

Description

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study); ODM derived from: https://clinicaltrials.gov/show/NCT01945775

Link

https://clinicaltrials.gov/show/NCT01945775

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01945775

English

Eligibility Breast Neoplasms NCT01945775

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed carcinoma of the breast
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
locally advanced and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
Description

Advanced disease Locally | Neoplasm Metastasis | Appropriateness Cytotoxic Chemotherapy Systemic Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0814634
UMLS CUI [3,2]
C0677881
UMLS CUI [3,3]
C0205373
UMLS CUI [3,4]
C0205171
deleterious or pathogenic germline brca1 or brca2 mutation
Description

Germline BRCA1 mutation Deleterious | Germline BRCA1 mutation Pathogenic | Germline BRCA2 mutation Deleterious | Germline BRCA2 mutation Pathogenic

Data type

boolean

Alias
UMLS CUI [1,1]
C3845275
UMLS CUI [1,2]
C1511022
UMLS CUI [1,3]
C2985436
UMLS CUI [2,1]
C3845275
UMLS CUI [2,2]
C1511022
UMLS CUI [2,3]
C3816499
UMLS CUI [3,1]
C3845275
UMLS CUI [3,2]
C1511024
UMLS CUI [3,3]
C2985436
UMLS CUI [4,1]
C3845275
UMLS CUI [4,2]
C1511024
UMLS CUI [4,3]
C3816499
no more than 2 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease
Description

Prior Chemotherapy Quantity | Therapeutic regimen Advanced disease Locally | Therapeutic regimen Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1276413
UMLS CUI [2,2]
C0679246
UMLS CUI [2,3]
C1517927
UMLS CUI [3,1]
C1276413
UMLS CUI [3,2]
C0027627
prior treatment with a taxane and/or anthracycline in the adjuvant or metastatic setting
Description

Prior Therapy Adjuvant | Prior Therapy Neoplasm Metastasis | taxane | Anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0027627
UMLS CUI [3]
C0215136
UMLS CUI [4]
C0282564
ecog performance status ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
have adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with a parp inhibitor
Description

Prior Therapy | PARP Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1882413
prior platinum treatment for metastatic disease. subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible
Description

Prior Therapy Neoplasm Metastasis | Platinum | Adjuvant therapy | Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C0032207
UMLS CUI [3]
C0677850
UMLS CUI [4]
C0600558
cns metastasis except adequately treated brain metastasis documented by baseline ct or mri scan that has not progressed since previous scans and that does not require corticosteroids for management of cns symptoms
Description

CNS metastases CT scan | CNS metastases MRI scan | Exception Metastatic malignant neoplasm to brain Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0220650
UMLS CUI [3,3]
C1522326
prior malignancy except for prior brca-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated ≥5 years prior to study enrollment with no subsequent evidence of recurrence
Description

Malignant Neoplasms Previous | Exception Malignant Neoplasm Associated with BRCA | Malignant Neoplasms Previous Absent | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Definitive Treatment Malignant Neoplasm | Exception Recurrence Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0596223
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699893
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C2986592
UMLS CUI [6,3]
C0006826
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0034897
UMLS CUI [7,3]
C0332197
known to be hiv positive, active hepatitis c virus, or active hepatitis b virus
Description

HIV Seropositivity | Hepatitis C virus | Hepatitis B Virus

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0220847
UMLS CUI [3]
C0019169
known hypersensitivity to any of the components of talazoparib
Description

Hypersensitivity Talazoparib Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4042960
UMLS CUI [1,3]
C1705248
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Similar models

Eligibility Breast Neoplasms NCT01945775

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histologically or cytologically confirmed carcinoma of the breast
boolean
C0678222 (UMLS CUI [1])
Advanced disease Locally | Neoplasm Metastasis | Appropriateness Cytotoxic Chemotherapy Systemic Single
Item
locally advanced and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0814634 (UMLS CUI [3,1])
C0677881 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
Germline BRCA1 mutation Deleterious | Germline BRCA1 mutation Pathogenic | Germline BRCA2 mutation Deleterious | Germline BRCA2 mutation Pathogenic
Item
deleterious or pathogenic germline brca1 or brca2 mutation
boolean
C3845275 (UMLS CUI [1,1])
C1511022 (UMLS CUI [1,2])
C2985436 (UMLS CUI [1,3])
C3845275 (UMLS CUI [2,1])
C1511022 (UMLS CUI [2,2])
C3816499 (UMLS CUI [2,3])
C3845275 (UMLS CUI [3,1])
C1511024 (UMLS CUI [3,2])
C2985436 (UMLS CUI [3,3])
C3845275 (UMLS CUI [4,1])
C1511024 (UMLS CUI [4,2])
C3816499 (UMLS CUI [4,3])
Prior Chemotherapy Quantity | Therapeutic regimen Advanced disease Locally | Therapeutic regimen Neoplasm Metastasis
Item
no more than 2 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1276413 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C1276413 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Prior Therapy Adjuvant | Prior Therapy Neoplasm Metastasis | taxane | Anthracyclines
Item
prior treatment with a taxane and/or anthracycline in the adjuvant or metastatic setting
boolean
C1514463 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
C0282564 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
have adequate organ function
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | PARP Inhibitors
Item
prior treatment with a parp inhibitor
boolean
C1514463 (UMLS CUI [1])
C1882413 (UMLS CUI [2])
Prior Therapy Neoplasm Metastasis | Platinum | Adjuvant therapy | Neoadjuvant Therapy
Item
prior platinum treatment for metastatic disease. subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible
boolean
C1514463 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0032207 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
C0600558 (UMLS CUI [4])
CNS metastases CT scan | CNS metastases MRI scan | Exception Metastatic malignant neoplasm to brain Treated
Item
cns metastasis except adequately treated brain metastasis documented by baseline ct or mri scan that has not progressed since previous scans and that does not require corticosteroids for management of cns symptoms
boolean
C0686377 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Malignant Neoplasms Previous | Exception Malignant Neoplasm Associated with BRCA | Malignant Neoplasms Previous Absent | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Definitive Treatment Malignant Neoplasm | Exception Recurrence Absent
Item
prior malignancy except for prior brca-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated ≥5 years prior to study enrollment with no subsequent evidence of recurrence
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0596223 (UMLS CUI [2,4])
C0006826 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C2986592 (UMLS CUI [6,2])
C0006826 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0034897 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
HIV Seropositivity | Hepatitis C virus | Hepatitis B Virus
Item
known to be hiv positive, active hepatitis c virus, or active hepatitis b virus
boolean
C0019699 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
C0019169 (UMLS CUI [3])
Hypersensitivity Talazoparib Component
Item
known hypersensitivity to any of the components of talazoparib
boolean
C0020517 (UMLS CUI [1,1])
C4042960 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
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