ID

38142

Description

Phase 2 Trial of AEZS-108 in Chemotherapy Refractory in Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01698281

Link

https://clinicaltrials.gov/show/NCT01698281

Keywords

Versions (1)
  1. 9/22/19 9/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01698281

English

Eligibility Breast Cancer NCT01698281

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women ≥ 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically documented breast cancer (either primary or metastatic site) that is (i) er-negative (0), (ii) pr-negative (0), and (iii) her2-negative, defined by ihc (immunohistochemistry; ihc 0/1, non-overexpressing) or fish (fluorescence in situ hybridization; fish negative) or cish (chromogen in situ hybridization; cish negative).
Description

Breast Carcinoma | Secondary malignant neoplasm of female breast | Breast Carcinoma Estrogen receptor negative | Breast Carcinoma Progesterone receptor negative | Breast Carcinoma HER2 Negative | Immunohistochemistry | Overexpression Absent | FISH Negative | CISH Negative

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0279756
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0279766
UMLS CUI [5,1]
C0678222
UMLS CUI [5,2]
C2348908
UMLS CUI [6]
C0021044
UMLS CUI [7,1]
C1514559
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0162789
UMLS CUI [8,2]
C1513916
UMLS CUI [9,1]
C1516514
UMLS CUI [9,2]
C1513916
3. expression of lhrh receptor confirmed by ihc on archival (or current biopsy of breast tumor or metastatic site) breast cancer tissue
Description

LHRH Receptor Expression | Breast Carcinoma Tissue specimen Immunohistochemistry | Breast Carcinoma Biopsy | Metastatic cancer site Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0034811
UMLS CUI [1,2]
C0017262
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1292533
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0005558
UMLS CUI [4,1]
C0280457
UMLS CUI [4,2]
C0005558
4. progressive disease after failure of 1 to 3 prior chemotherapy regimens for recurrent or metastatic (stage iv) disease (prior adjuvant/neoadjuvant therapy is allowed)
Description

Progressive Disease | Prior Chemotherapy Quantity failed | Recurrent disease TNM Breast tumor staging | Neoplasm Metastasis TNM Breast tumor staging | Adjuvant therapy Previous | Neoadjuvant Therapy Previous

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0474926
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0474926
UMLS CUI [5,1]
C0677850
UMLS CUI [5,2]
C0205156
UMLS CUI [6,1]
C0600558
UMLS CUI [6,2]
C0205156
5. measurable disease by recist 1.1 criteria; at least one target lesion that has not been previously irradiated.
Description

Measurable Disease | Prior radiation therapy Absent Target Lesion Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C2986546
UMLS CUI [2,4]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. eastern cooperative oncology group (ecog) performance status > 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment)
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0027051
3. leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
Description

Leptomeningeal disease | Metastatic malignant neoplasm to brain | Requirement Steroids | Requirement Therapeutic Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0751297
UMLS CUI [2]
C0220650
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0038317
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0808232
4. left ventricular ejection fraction (lvef) < 50 %, determined by echocardiogram or muga scan
Description

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
5. compromised organ or marrow function as evidenced by any of the following:
Description

Organ function Impaired | Bone Marrow function Impaired

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0221099
thrombocyte count: < 100x109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
absolute neutrophil count (anc): < 1.5x109/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin: < 6.0 mmol/l (< 9 g/100 ml)
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
as(a)t, al(a)t: > 2.5 times upper limit of normal range (uln) (> 5x uln if clearly related to liver metastases)
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
bilirubin: > 1.5 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine: > 1.5 mg/dl or creatinine clearance < 40 ml/min.
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
6. systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug*)
Description

Cancer treatment Systemic | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1522449
* also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study
Description

Cancer treatment concomitant

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0521115
7. prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (doxil), doxorubicin, daunorubicin, or mitoxantrone
Description

Exposure to Anthracyclines | Exposure to Anthraquinones | Therapy Secondary malignant neoplasm of female breast | doxorubicin liposome | Doxil | Doxorubicin | Daunorubicin | Mitoxantrone

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0282564
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0003174
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0346993
UMLS CUI [4]
C0717726
UMLS CUI [5]
C0279284
UMLS CUI [6]
C0013089
UMLS CUI [7]
C0011015
UMLS CUI [8]
C0026259
8. prior adjuvant anthracyclines with a cumulative anthracycline dose ≥ 300 mg/m2
Description

Adjuvant therapy | Anthracyclines Cumulative Dose

Data type

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2,1]
C0282564
UMLS CUI [2,2]
C2986497
9. ongoing therapeutic anticoagulation
Description

Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003281
10. patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as:
Description

Contraceptive methods mandatory | Exception Sexual sterilization | Exception Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038288
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0232970
complete abstinence
Description

Sexual Abstinence Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0036899
UMLS CUI [1,2]
C0205197
any intrauterine device (iud) with published data showing that the lowest expected failure rate is < 1 % per year, or
Description

Intrauterine Devices

Data type

boolean

Alias
UMLS CUI [1]
C0021900
any other methods with published data showing that the lowest expected failure rate is less than 1 % per year
Description

Contraceptive methods Effective

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1280519
11. investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
Description

Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0949266
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Similar models

Eligibility Breast Cancer NCT01698281

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. women ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma | Secondary malignant neoplasm of female breast | Breast Carcinoma Estrogen receptor negative | Breast Carcinoma Progesterone receptor negative | Breast Carcinoma HER2 Negative | Immunohistochemistry | Overexpression Absent | FISH Negative | CISH Negative
Item
2. histologically documented breast cancer (either primary or metastatic site) that is (i) er-negative (0), (ii) pr-negative (0), and (iii) her2-negative, defined by ihc (immunohistochemistry; ihc 0/1, non-overexpressing) or fish (fluorescence in situ hybridization; fish negative) or cish (chromogen in situ hybridization; cish negative).
boolean
C0678222 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0279756 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0279766 (UMLS CUI [4,2])
C0678222 (UMLS CUI [5,1])
C2348908 (UMLS CUI [5,2])
C0021044 (UMLS CUI [6])
C1514559 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0162789 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C1516514 (UMLS CUI [9,1])
C1513916 (UMLS CUI [9,2])
LHRH Receptor Expression | Breast Carcinoma Tissue specimen Immunohistochemistry | Breast Carcinoma Biopsy | Metastatic cancer site Biopsy
Item
3. expression of lhrh receptor confirmed by ihc on archival (or current biopsy of breast tumor or metastatic site) breast cancer tissue
boolean
C0034811 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C0280457 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Progressive Disease | Prior Chemotherapy Quantity failed | Recurrent disease TNM Breast tumor staging | Neoplasm Metastasis TNM Breast tumor staging | Adjuvant therapy Previous | Neoadjuvant Therapy Previous
Item
4. progressive disease after failure of 1 to 3 prior chemotherapy regimens for recurrent or metastatic (stage iv) disease (prior adjuvant/neoadjuvant therapy is allowed)
boolean
C1335499 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C0677850 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
Measurable Disease | Prior radiation therapy Absent Target Lesion Quantity
Item
5. measurable disease by recist 1.1 criteria; at least one target lesion that has not been previously irradiated.
boolean
C1513041 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2986546 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
ECOG performance status
Item
1. eastern cooperative oncology group (ecog) performance status > 2
boolean
C1520224 (UMLS CUI [1])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Myocardial Infarction
Item
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
Leptomeningeal disease | Metastatic malignant neoplasm to brain | Requirement Steroids | Requirement Therapeutic Intervention
Item
3. leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
boolean
C0751297 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0808232 (UMLS CUI [4,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
4. left ventricular ejection fraction (lvef) < 50 %, determined by echocardiogram or muga scan
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Organ function Impaired | Bone Marrow function Impaired
Item
5. compromised organ or marrow function as evidenced by any of the following:
boolean
C0678852 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
Platelet Count measurement
Item
thrombocyte count: < 100x109/l
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc): < 1.5x109/l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin: < 6.0 mmol/l (< 9 g/100 ml)
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver
Item
as(a)t, al(a)t: > 2.5 times upper limit of normal range (uln) (> 5x uln if clearly related to liver metastases)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Serum total bilirubin measurement
Item
bilirubin: > 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine: > 1.5 mg/dl or creatinine clearance < 40 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Cancer treatment Systemic | Therapeutic radiology procedure
Item
6. systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug*)
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
Cancer treatment concomitant
Item
* also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study
boolean
C0920425 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
Exposure to Anthracyclines | Exposure to Anthraquinones | Therapy Secondary malignant neoplasm of female breast | doxorubicin liposome | Doxil | Doxorubicin | Daunorubicin | Mitoxantrone
Item
7. prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (doxil), doxorubicin, daunorubicin, or mitoxantrone
boolean
C0332157 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0003174 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0346993 (UMLS CUI [3,2])
C0717726 (UMLS CUI [4])
C0279284 (UMLS CUI [5])
C0013089 (UMLS CUI [6])
C0011015 (UMLS CUI [7])
C0026259 (UMLS CUI [8])
Adjuvant therapy | Anthracyclines Cumulative Dose
Item
8. prior adjuvant anthracyclines with a cumulative anthracycline dose ≥ 300 mg/m2
boolean
C0677850 (UMLS CUI [1])
C0282564 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
Anticoagulation Therapy
Item
9. ongoing therapeutic anticoagulation
boolean
C0003281 (UMLS CUI [1])
Contraceptive methods mandatory | Exception Sexual sterilization | Exception Postmenopausal state
Item
10. patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as:
boolean
C0700589 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0038288 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
Sexual Abstinence Complete
Item
complete abstinence
boolean
C0036899 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Intrauterine Devices
Item
any intrauterine device (iud) with published data showing that the lowest expected failure rate is < 1 % per year, or
boolean
C0021900 (UMLS CUI [1])
Contraceptive methods Effective
Item
any other methods with published data showing that the lowest expected failure rate is less than 1 % per year
boolean
C0700589 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
Therapy, Investigational
Item
11. investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
boolean
C0949266 (UMLS CUI [1])
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