ID

34949

Descripción

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02032823

Link

https://clinicaltrials.gov/show/NCT02032823

Palabras clave

Versiones (1)
  1. 5/2/19 5/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02032823

Inglés

Eligibility Breast Cancer NCT02032823

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast. •invasive triple negative breast cancer
Descripción

Breast adenocarcinoma Invasive Triple Negative Primary | Triple Negative Breast Neoplasm Invasive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0205174
UMLS CUI [1,4]
C1513916
UMLS CUI [1,5]
C0205225
UMLS CUI [2,1]
C3539878
UMLS CUI [2,2]
C0205281
documented mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
Descripción

Deleterious BRCA1 Gene Mutation predicted | Deleterious BRCA2 Gene Mutation predicted | Deleterious BRCA1 Gene Mutation Suspected | Deleterious BRCA2 Gene Mutation Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4289700
UMLS CUI [1,2]
C0681842
UMLS CUI [2,1]
C4287905
UMLS CUI [2,2]
C0681842
UMLS CUI [3,1]
C4289700
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C4287905
UMLS CUI [4,2]
C0750491
completed adequate breast and axilla surgery.
Descripción

Operation on breast Completed | Operative Surgical Procedure Axillary Completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0004454
UMLS CUI [2,3]
C0205197
completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
Descripción

Anthracyclines | taxane | Combined Modality Therapy | Platinum | Curative treatment Malignant Neoplasms | Curative treatment Ovarian Carcinoma | Adjuvant therapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0215136
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0032207
UMLS CUI [5,1]
C1273390
UMLS CUI [5,2]
C0006826
UMLS CUI [6,1]
C1273390
UMLS CUI [6,2]
C0029925
UMLS CUI [7,1]
C0677850
UMLS CUI [7,2]
C0678222
UMLS CUI [8,1]
C0600558
UMLS CUI [8,2]
C0678222
ecog 0-1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous treatment with a parp inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.
Descripción

PARP Inhibitors | olaparib | Hypersensitivity Investigational New Drugs Pharmaceutical Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1882413
UMLS CUI [2]
C2316164
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0015237
patients with second primary cancer, exceptions: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (dcis) of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years prior to randomization. more than one course of chemotherapy for previous malignancies.
Descripción

Second Primary Cancers | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS | Exception Curative treatment Endometrial cancer Stage Grade | Exception Curative treatment Solid Neoplasm | Exception Curative treatment Lymphoma Without Bone Marrow Involvement | Exception Disease Free of Duration | Chemotherapy cycle Quantity Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0280255
UMLS CUI [5,4]
C0441800
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0280100
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1273390
UMLS CUI [7,3]
C0024299
UMLS CUI [7,4]
C0332288
UMLS CUI [7,5]
C1517677
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0012634
UMLS CUI [8,3]
C0332296
UMLS CUI [8,4]
C0449238
UMLS CUI [9,1]
C1302181
UMLS CUI [9,2]
C1265611
UMLS CUI [9,3]
C0006826
resting ecg with qtc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long qt syndrome. if ecg demonstrates qtc >470 msec, patient will be eligible only if repeat ecg demonstrates qtc ≤470 msec.
Descripción

Prolonged QTc ECG Resting | Family history of long QT syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1969409
UMLS CUI [1,2]
C0013798
UMLS CUI [1,3]
C0035253
UMLS CUI [2]
C3839836
concomitant use of known potent cyp3a4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
Descripción

CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Saquinavir | telithromycin | Clarithromycin | Nelfinavir

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0292818
UMLS CUI [5]
C0376637
UMLS CUI [6]
C0286738
UMLS CUI [7]
C0907410
UMLS CUI [8]
C0055856
UMLS CUI [9]
C0525005
whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gbrca testing
Descripción

Whole blood transfusion | Interference Germline BRCA Testing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0199961
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C3845275
UMLS CUI [2,3]
C0596223
UMLS CUI [2,4]
C0039593
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Similar models

Eligibility Breast Cancer NCT02032823

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Invasive Triple Negative Primary | Triple Negative Breast Neoplasm Invasive
Item
histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast. •invasive triple negative breast cancer
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205174 (UMLS CUI [1,3])
C1513916 (UMLS CUI [1,4])
C0205225 (UMLS CUI [1,5])
C3539878 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
Deleterious BRCA1 Gene Mutation predicted | Deleterious BRCA2 Gene Mutation predicted | Deleterious BRCA1 Gene Mutation Suspected | Deleterious BRCA2 Gene Mutation Suspected
Item
documented mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
boolean
C4289700 (UMLS CUI [1,1])
C0681842 (UMLS CUI [1,2])
C4287905 (UMLS CUI [2,1])
C0681842 (UMLS CUI [2,2])
C4289700 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C4287905 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Operation on breast Completed | Operative Surgical Procedure Axillary Completed
Item
completed adequate breast and axilla surgery.
boolean
C3714726 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Anthracyclines | taxane | Combined Modality Therapy | Platinum | Curative treatment Malignant Neoplasms | Curative treatment Ovarian Carcinoma | Adjuvant therapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma
Item
completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0032207 (UMLS CUI [4])
C1273390 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1273390 (UMLS CUI [6,1])
C0029925 (UMLS CUI [6,2])
C0677850 (UMLS CUI [7,1])
C0678222 (UMLS CUI [7,2])
C0600558 (UMLS CUI [8,1])
C0678222 (UMLS CUI [8,2])
ECOG performance status
Item
ecog 0-1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
PARP Inhibitors | olaparib | Hypersensitivity Investigational New Drugs Pharmaceutical Excipient
Item
any previous treatment with a parp inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.
boolean
C1882413 (UMLS CUI [1])
C2316164 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Second Primary Cancers | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment DCIS | Exception Curative treatment Endometrial cancer Stage Grade | Exception Curative treatment Solid Neoplasm | Exception Curative treatment Lymphoma Without Bone Marrow Involvement | Exception Disease Free of Duration | Chemotherapy cycle Quantity Malignant Neoplasms
Item
patients with second primary cancer, exceptions: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (dcis) of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years prior to randomization. more than one course of chemotherapy for previous malignancies.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007124 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0280255 (UMLS CUI [5,3])
C0441800 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0280100 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0024299 (UMLS CUI [7,3])
C0332288 (UMLS CUI [7,4])
C1517677 (UMLS CUI [7,5])
C1705847 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
C0332296 (UMLS CUI [8,3])
C0449238 (UMLS CUI [8,4])
C1302181 (UMLS CUI [9,1])
C1265611 (UMLS CUI [9,2])
C0006826 (UMLS CUI [9,3])
Prolonged QTc ECG Resting | Family history of long QT syndrome
Item
resting ecg with qtc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long qt syndrome. if ecg demonstrates qtc >470 msec, patient will be eligible only if repeat ecg demonstrates qtc ≤470 msec.
boolean
C1969409 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C3839836 (UMLS CUI [2])
CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Ritonavir | Indinavir | Saquinavir | telithromycin | Clarithromycin | Nelfinavir
Item
concomitant use of known potent cyp3a4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0376637 (UMLS CUI [5])
C0286738 (UMLS CUI [6])
C0907410 (UMLS CUI [7])
C0055856 (UMLS CUI [8])
C0525005 (UMLS CUI [9])
Whole blood transfusion | Interference Germline BRCA Testing
Item
whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gbrca testing
boolean
C0199961 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C3845275 (UMLS CUI [2,2])
C0596223 (UMLS CUI [2,3])
C0039593 (UMLS CUI [2,4])
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