ID

34889

Description

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.; ODM derived from: https://clinicaltrials.gov/show/NCT02000622

Link

https://clinicaltrials.gov/show/NCT02000622

Keywords

Versions (1)
  1. 2/3/19 2/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer Metastatic NCT02000622

English

Eligibility Breast Cancer Metastatic NCT02000622

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
germline mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious.
Description

Deleterious Germline Mutation BRCA1 predicted | Deleterious Germline Mutation BRCA2 predicted | Deleterious Germline Mutation BRCA1 Suspected | Deleterious Germline Mutation BRCA2 Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C4329707
UMLS CUI [1,2]
C0376571
UMLS CUI [1,3]
C0681842
UMLS CUI [2,1]
C4329707
UMLS CUI [2,2]
C0598034
UMLS CUI [2,3]
C0681842
UMLS CUI [3,1]
C4329707
UMLS CUI [3,2]
C0376571
UMLS CUI [3,3]
C0750491
UMLS CUI [4,1]
C4329707
UMLS CUI [4,2]
C0598034
UMLS CUI [4,3]
C0750491
histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
Description

Anthracycline Adjuvant therapy | Anthracycline Metastatic Setting | Taxane Adjuvant therapy | Taxane Metastatic Setting

Data type

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0282564
UMLS CUI [2,2]
C4085632
UMLS CUI [3,1]
C0215136
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C0215136
UMLS CUI [4,2]
C4085632
prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
Description

Platinum | Breast Carcinoma Progression Absent | Platinum Adjuvant therapy | Platinum Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0032207
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0449258
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0032207
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C0032207
UMLS CUI [4,2]
C0600558
er/pr breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Description

Breast Carcinoma Estrogen receptor positive | Breast Carcinoma Progesterone receptor positive | Hormone Therapy Adjuvant Quantity | Hormone Therapy Quantity Metastatic Setting | Disease Progression | Disease Inappropriate Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C1522673
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C4085632
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C0279025
ecog performance status 0-1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, kidney and liver function.
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with parp inhibitor.
Description

Poly(ADP-ribose) Polymerase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1882413
patients with her2 positive disease.
Description

Disease HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
more than 2 prior lines of chemotherapy for metastatic breast cancer.
Description

Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
untreated and/or uncontrolled brain metastases.
Description

Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205318
prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, dcis or stage i grade 1 endometrial cancer allowed.
Description

Malignant Neoplasms | Exception Curative treatment | Exception Disease Free Duration | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Endometrial cancer stage Grade Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0007124
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0280255
UMLS CUI [7,3]
C0441800
UMLS CUI [7,4]
C1522326
known hiv (human immunodeficiency virus) infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
pregnant or breast-feeding women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer Metastatic NCT02000622

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Deleterious Germline Mutation BRCA1 predicted | Deleterious Germline Mutation BRCA2 predicted | Deleterious Germline Mutation BRCA1 Suspected | Deleterious Germline Mutation BRCA2 Suspected
Item
germline mutation in brca1 or brca2 that is predicted to be deleterious or suspected deleterious.
boolean
C4329707 (UMLS CUI [1,1])
C0376571 (UMLS CUI [1,2])
C0681842 (UMLS CUI [1,3])
C4329707 (UMLS CUI [2,1])
C0598034 (UMLS CUI [2,2])
C0681842 (UMLS CUI [2,3])
C4329707 (UMLS CUI [3,1])
C0376571 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
C4329707 (UMLS CUI [4,1])
C0598034 (UMLS CUI [4,2])
C0750491 (UMLS CUI [4,3])
Secondary malignant neoplasm of female breast
Item
histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
boolean
C0346993 (UMLS CUI [1])
Anthracycline Adjuvant therapy | Anthracycline Metastatic Setting | Taxane Adjuvant therapy | Taxane Metastatic Setting
Item
prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
boolean
C0282564 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2,1])
C4085632 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0215136 (UMLS CUI [4,1])
C4085632 (UMLS CUI [4,2])
Platinum | Breast Carcinoma Progression Absent | Platinum Adjuvant therapy | Platinum Neoadjuvant Therapy
Item
prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
boolean
C0032207 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0449258 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0032207 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0032207 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
Breast Carcinoma Estrogen receptor positive | Breast Carcinoma Progesterone receptor positive | Hormone Therapy Adjuvant Quantity | Hormone Therapy Quantity Metastatic Setting | Disease Progression | Disease Inappropriate Hormone Therapy
Item
er/pr breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
boolean
C0678222 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0279025 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C4085632 (UMLS CUI [4,3])
C0242656 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C0279025 (UMLS CUI [6,3])
ECOG performance status
Item
ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, kidney and liver function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Poly(ADP-ribose) Polymerase Inhibitors
Item
prior treatment with parp inhibitor.
boolean
C1882413 (UMLS CUI [1])
Disease HER2 Positive
Item
patients with her2 positive disease.
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
more than 2 prior lines of chemotherapy for metastatic breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Uncontrolled
Item
untreated and/or uncontrolled brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Curative treatment | Exception Disease Free Duration | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Endometrial cancer stage Grade Treated
Item
prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, dcis or stage i grade 1 endometrial cancer allowed.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0007124 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0280255 (UMLS CUI [7,2])
C0441800 (UMLS CUI [7,3])
C1522326 (UMLS CUI [7,4])
HIV Infection
Item
known hiv (human immunodeficiency virus) infection.
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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