ID

35081

Beschreibung

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study); ODM derived from: https://clinicaltrials.gov/show/NCT02034916

Link

https://clinicaltrials.gov/show/NCT02034916

Stichworte

Versionen (1)
  1. 14.02.19 14.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. Februar 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02034916

Englisch

Eligibility Breast Neoplasms NCT02034916

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
locally advanced and/or metastatic disease
Beschreibung

Advanced disease Locally | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
deleterious or pathogenic germline brca 1 or brca 2 mutation
Beschreibung

Deleterious BRCA1 Gene Mutation | BRCA1 gene mutation Pathogenic | Deleterious BRCA2 Gene Mutation | BRCA2 gene mutation Pathogenic

Datentyp

boolean

Alias
UMLS CUI [1]
C4289700
UMLS CUI [2,1]
C1511022
UMLS CUI [2,2]
C3816499
UMLS CUI [3]
C4287905
UMLS CUI [4,1]
C1511024
UMLS CUI [4,2]
C3816499
prior chemotherapy: cohort 1) pr or cr to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
Beschreibung

Prior Chemotherapy | Partial response Platinum Neoplasm Metastasis | In complete remission Platinum Neoplasm Metastasis | Disease Progression | Chemotherapy Regimen Quantity Neoplasm Metastasis | Platinum Absent Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0032207
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0032207
UMLS CUI [3,3]
C0027627
UMLS CUI [4]
C0242656
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0027627
UMLS CUI [6,1]
C0032207
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0027627
ecog performance status ≤ 1
Beschreibung

ECOG performance status

Datentyp

boolean

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

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior enrollment into a clinical trial of a parp inhibitor
Beschreibung

Study Subject Participation Status | PARP Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1882413
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
Beschreibung

CNS metastases CT | CNS metastases MRI scan | Exception Metastatic malignant neoplasm to brain Treated | Disease Progression Absent | Adrenal Cortex Hormones Absent

Datentyp

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
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0001617
UMLS CUI [5,2]
C0332197
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
Beschreibung

Malignant Neoplasms Previous | Exception Malignant Neoplasm Associated with BRCA gene | Exception Disease Free | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasm Treated | Exception Recurrence Absent

Datentyp

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]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
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]
C0006826
UMLS CUI [6,3]
C1522326
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
Beschreibung

HIV Seropositivity | Hepatitis C virus | Hepatitis B Virus

Datentyp

boolean

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

Hypersensitivity Talazoparib Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4042960
UMLS CUI [1,3]
C1705248
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Ähnliche Modelle

Eligibility Breast Neoplasms NCT02034916

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Item
locally advanced and/or metastatic disease
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
Deleterious BRCA1 Gene Mutation | BRCA1 gene mutation Pathogenic | Deleterious BRCA2 Gene Mutation | BRCA2 gene mutation Pathogenic
Item
deleterious or pathogenic germline brca 1 or brca 2 mutation
boolean
C4289700 (UMLS CUI [1])
C1511022 (UMLS CUI [2,1])
C3816499 (UMLS CUI [2,2])
C4287905 (UMLS CUI [3])
C1511024 (UMLS CUI [4,1])
C3816499 (UMLS CUI [4,2])
Prior Chemotherapy | Partial response Platinum Neoplasm Metastasis | In complete remission Platinum Neoplasm Metastasis | Disease Progression | Chemotherapy Regimen Quantity Neoplasm Metastasis | Platinum Absent Neoplasm Metastasis
Item
prior chemotherapy: cohort 1) pr or cr to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
boolean
C1514457 (UMLS CUI [1])
C1521726 (UMLS CUI [2,1])
C0032207 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0677874 (UMLS CUI [3,1])
C0032207 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0027627 (UMLS CUI [5,3])
C0032207 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0027627 (UMLS CUI [6,3])
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)
Study Subject Participation Status | PARP Inhibitors
Item
prior enrollment into a clinical trial of a parp inhibitor
boolean
C2348568 (UMLS CUI [1])
C1882413 (UMLS CUI [2])
CNS metastases CT | CNS metastases MRI scan | Exception Metastatic malignant neoplasm to brain Treated | Disease Progression Absent | Adrenal Cortex Hormones Absent
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])
C0242656 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0001617 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Malignant Neoplasms Previous | Exception Malignant Neoplasm Associated with BRCA gene | Exception Disease Free | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasm Treated | 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])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (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])
C0006826 (UMLS CUI [6,2])
C1522326 (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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