ID

14776

Beschreibung

Neoadjuvant BMN673 for Patients With a BRCA Deleterious Mutation; ODM derived from: https://clinicaltrials.gov/show/NCT02282345

Link

https://clinicaltrials.gov/show/NCT02282345

Stichworte

Versionen (1)
  1. 27.04.16 27.04.16 -
Hochgeladen am

27. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02282345

Englisch

Eligibility Breast Cancer NCT02282345

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1 cm on imaging by either mammography, ultrasound or breast mri
Beschreibung

Breast adenocarcinoma Invasive | Tumor size | Mammography | Ultrasonics (sound) | Magnetic resonance imaging of breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0475440
UMLS CUI [3]
C0024671
UMLS CUI [4]
C1456803
UMLS CUI [5]
C0344104
3. negative her-2/neu- disease defined as patients with fish ratio <2.0 or <6.0 her2 gene copies per nucleus, and ihc staining scores of 0, 1+, or 2+.
Beschreibung

Negative erbB-2 Receptor Disease | Fluorescent in Situ Hybridization | Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205160
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C0012634
UMLS CUI [2]
C0162789
UMLS CUI [3]
C0021044
4. no prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. subjects receiving hormone replacement treatment (hrt) are eligible if this therapy is discontinued at least 2 weeks before starting study therapy. treatment for dcis is allowed, such as surgery, hormonal therapy and radiotherapy.
Beschreibung

Therapeutic procedure Breast adenocarcinoma Invasive | Therapeutic radiology procedure | Chemotherapy Regimen | Hormone Therapy | Immunotherapy | Therapies, Investigational | Surgery specialty | Hormone replacement therapy | Noninfiltrating Intraductal Carcinoma | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0858252
UMLS CUI [1,3]
C0205281
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0949266
UMLS CUI [7]
C0038894
UMLS CUI [8]
C0282402
UMLS CUI [9]
C0007124
UMLS CUI [10]
C1522449
5. ecog performance status of 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. baseline muga or echocardiogram scans with lvef of > 50%.
Beschreibung

Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiogram

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
UMLS CUI [3]
C2243117
7. patient must have adequate organ function as determined by the following laboratory values: a. anc>/=1,500 /ul b. platelets >/=100,000 / ul c. hgb >/= 9 g/dl d. creatinine clearance >50 ml/min e. total bilirubin </= 1.5 x uln f. alt and ast < 2.5 x uln
Beschreibung

body system or organ function | Absolute neutrophil count | Blood Platelets | Hemoglobin | Creatinine clearance measurement | Bilirubin, total measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0019046
UMLS CUI [5]
C0373595
UMLS CUI [6]
C0201913
8. men or women 18 years of age or older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
9. women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. for the purposes of this study, wocbp will be considered 12 months without menstruation. men on study also must be using contraception.
Beschreibung

Gender | Childbearing Potential Contraceptive methods | Pregnancy | Investigational New Drugs | Menstruation | Male Contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0013230
UMLS CUI [5]
C0025344
UMLS CUI [6]
C0086580
10. negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines.
Beschreibung

Serum pregnancy test negative | Urine pregnancy test negative | Investigational New Drugs | Gender | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0430061
UMLS CUI [2]
C0430057
UMLS CUI [3]
C0013230
UMLS CUI [4]
C0079399
UMLS CUI [5]
C3831118
11. identified deleterious mutation in brca 1 or 2 genes ( this does not include variants of uncertain significance).
Beschreibung

brca gene Mutation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596223
UMLS CUI [1,2]
C0026882
12. eligible to receive standard of care chemotherapy and/or surgery based upon standard practices or institutional guidelines.
Beschreibung

Standard of Care Chemotherapy Regimen | Standard of Care Surgery specialty

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0038894
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
Beschreibung

Pregnancy Pregnancy test positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
2. disease free of prior malignancy for < 5 years with the exception of curatively treated basal carcinoma of the skin or carcinoma in situ of the cervix.
Beschreibung

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
3. any other previous antitumor therapies for the current cancer event. treatment for dcis is allowed, such as surgery, hormonal therapy and radiotherapy.
Beschreibung

cancer treatment | Noninfiltrating Intraductal Carcinoma | Surgery specialty | Hormone Therapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0038894
UMLS CUI [4]
C0279025
UMLS CUI [5]
C1522449
4. has had major surgery within 21 days before cycle 1 day 1
Beschreibung

major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
5. gastrointestinal tract disease or defect with associated malabsorption syndrome
Beschreibung

Gastrointestinal Diseases | Abnormality of the abdominal organs | Malabsorption Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C4021764
UMLS CUI [3]
C0024523
6. uncontrolled inflammatory bowel disease (e.g., crohn's disease, ulcerative colitis)
Beschreibung

Inflammatory Bowel Diseases Uncontrolled | Crohn Disease | Ulcerative Colitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
7. myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (new york heart association > class ii), unstable angina, or unstable cardiac arrhythmia requiring medication
Beschreibung

Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable status | Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0443343
UMLS CUI [5]
C0013227
8. serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
Beschreibung

Infection | Illness Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C3714514
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205318
9. psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols
Beschreibung

Mental disorders | Disease | Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0012634
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
10. unable to take oral medications
Beschreibung

Unable oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0175795
11. known to be human immunodeficiency virus positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
12. known active hepatitis c virus, or known active hepatitis b virus
Beschreibung

Hepatitis C virus | Hepatitis B Virus

Datentyp

boolean

Alias
UMLS CUI [1]
C0220847
UMLS CUI [2]
C0019169
13. concurrent disease or condition that would interfere with study participation or safety, such as any of the following: • active, clinically significant infection either grade > 2 by national cancer institute (nci) common terminology criteria for adverse events (ctcae) v4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug • clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders • non-healing wound, ulcer, or bone fracture
Beschreibung

Disease Study Subject Participation Status Limited | Communicable Diseases CTCAE | Antimicrobial medicament Parenteral | Blood Coagulation Disorders | Abnormal platelet function | Injury wounds | Ulcer | Fracture

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0443071
UMLS CUI [3,2]
C1518896
UMLS CUI [4]
C0005779
UMLS CUI [5]
C0855740
UMLS CUI [6]
C0043250
UMLS CUI [7]
C0041582
UMLS CUI [8]
C0016658
14. known hypersensitivity to any of the components of bmn 673
Beschreibung

Hypersensitivity BMN 673 MEDICATION COMPONENT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2987384
UMLS CUI [1,3]
C0184498
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Ähnliche Modelle

Eligibility Breast Cancer NCT02282345

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Breast adenocarcinoma Invasive | Tumor size | Mammography | Ultrasonics (sound) | Magnetic resonance imaging of breast
Item
2. histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1 cm on imaging by either mammography, ultrasound or breast mri
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
C1456803 (UMLS CUI [4])
C0344104 (UMLS CUI [5])
Negative erbB-2 Receptor Disease | Fluorescent in Situ Hybridization | Immunohistochemistry
Item
3. negative her-2/neu- disease defined as patients with fish ratio <2.0 or <6.0 her2 gene copies per nucleus, and ihc staining scores of 0, 1+, or 2+.
boolean
C0205160 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0162789 (UMLS CUI [2])
C0021044 (UMLS CUI [3])
Therapeutic procedure Breast adenocarcinoma Invasive | Therapeutic radiology procedure | Chemotherapy Regimen | Hormone Therapy | Immunotherapy | Therapies, Investigational | Surgery specialty | Hormone replacement therapy | Noninfiltrating Intraductal Carcinoma | Therapeutic radiology procedure
Item
4. no prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. subjects receiving hormone replacement treatment (hrt) are eligible if this therapy is discontinued at least 2 weeks before starting study therapy. treatment for dcis is allowed, such as surgery, hormonal therapy and radiotherapy.
boolean
C0087111 (UMLS CUI [1,1])
C0858252 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C0038894 (UMLS CUI [7])
C0282402 (UMLS CUI [8])
C0007124 (UMLS CUI [9])
C1522449 (UMLS CUI [10])
ECOG performance status
Item
5. ecog performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiogram
Item
6. baseline muga or echocardiogram scans with lvef of > 50%.
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C2243117 (UMLS CUI [3])
body system or organ function | Absolute neutrophil count | Blood Platelets | Hemoglobin | Creatinine clearance measurement | Bilirubin, total measurement
Item
7. patient must have adequate organ function as determined by the following laboratory values: a. anc>/=1,500 /ul b. platelets >/=100,000 / ul c. hgb >/= 9 g/dl d. creatinine clearance >50 ml/min e. total bilirubin </= 1.5 x uln f. alt and ast < 2.5 x uln
boolean
C0678852 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
Age
Item
8. men or women 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Gender | Childbearing Potential Contraceptive methods | Pregnancy | Investigational New Drugs | Menstruation | Male Contraception
Item
9. women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. for the purposes of this study, wocbp will be considered 12 months without menstruation. men on study also must be using contraception.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
C0025344 (UMLS CUI [5])
C0086580 (UMLS CUI [6])
Serum pregnancy test negative | Urine pregnancy test negative | Investigational New Drugs | Gender | Childbearing Potential
Item
10. negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines.
boolean
C0430061 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C3831118 (UMLS CUI [5])
brca gene Mutation
Item
11. identified deleterious mutation in brca 1 or 2 genes ( this does not include variants of uncertain significance).
boolean
C0596223 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
Standard of Care Chemotherapy Regimen | Standard of Care Surgery specialty
Item
12. eligible to receive standard of care chemotherapy and/or surgery based upon standard practices or institutional guidelines.
boolean
C2936643 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0038894 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy Pregnancy test positive | Breast Feeding
Item
1. women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
2. disease free of prior malignancy for < 5 years with the exception of curatively treated basal carcinoma of the skin or carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
cancer treatment | Noninfiltrating Intraductal Carcinoma | Surgery specialty | Hormone Therapy | Therapeutic radiology procedure
Item
3. any other previous antitumor therapies for the current cancer event. treatment for dcis is allowed, such as surgery, hormonal therapy and radiotherapy.
boolean
C0920425 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0038894 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
major surgery
Item
4. has had major surgery within 21 days before cycle 1 day 1
boolean
C0679637 (UMLS CUI [1])
Gastrointestinal Diseases | Abnormality of the abdominal organs | Malabsorption Syndrome
Item
5. gastrointestinal tract disease or defect with associated malabsorption syndrome
boolean
C0017178 (UMLS CUI [1])
C4021764 (UMLS CUI [2])
C0024523 (UMLS CUI [3])
Inflammatory Bowel Diseases Uncontrolled | Crohn Disease | Ulcerative Colitis
Item
6. uncontrolled inflammatory bowel disease (e.g., crohn's disease, ulcerative colitis)
boolean
C0021390 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Myocardial Infarction | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Unstable status | Pharmaceutical Preparations
Item
7. myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (new york heart association > class ii), unstable angina, or unstable cardiac arrhythmia requiring medication
boolean
C0027051 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5])
Infection | Illness Uncontrolled
Item
8. serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
boolean
C3714514 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Mental disorders | Disease | Compliance behavior Limited
Item
9. psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols
boolean
C0004936 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Unable oral medication
Item
10. unable to take oral medications
boolean
C1299582 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
HIV Seropositivity
Item
11. known to be human immunodeficiency virus positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis C virus | Hepatitis B Virus
Item
12. known active hepatitis c virus, or known active hepatitis b virus
boolean
C0220847 (UMLS CUI [1])
C0019169 (UMLS CUI [2])
Disease Study Subject Participation Status Limited | Communicable Diseases CTCAE | Antimicrobial medicament Parenteral | Blood Coagulation Disorders | Abnormal platelet function | Injury wounds | Ulcer | Fracture
Item
13. concurrent disease or condition that would interfere with study participation or safety, such as any of the following: • active, clinically significant infection either grade > 2 by national cancer institute (nci) common terminology criteria for adverse events (ctcae) v4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug • clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders • non-healing wound, ulcer, or bone fracture
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0443071 (UMLS CUI [3,1])
C1518896 (UMLS CUI [3,2])
C0005779 (UMLS CUI [4])
C0855740 (UMLS CUI [5])
C0043250 (UMLS CUI [6])
C0041582 (UMLS CUI [7])
C0016658 (UMLS CUI [8])
Hypersensitivity BMN 673 MEDICATION COMPONENT
Item
14. known hypersensitivity to any of the components of bmn 673
boolean
C0020517 (UMLS CUI [1,1])
C2987384 (UMLS CUI [1,2])
C0184498 (UMLS CUI [1,3])
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