ID

34995

Description

Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02253459

Link

https://clinicaltrials.gov/show/NCT02253459

Keywords

Versions (1)
  1. 2/7/19 2/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02253459

English

Eligibility Breast Cancer NCT02253459

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,lacking standard therapy or being failed to or recurrent after standard therapy;
Description

Secondary malignant neoplasm of female breast Advanced | Standard therapy Lacking | Standard therapy failed | BREAST CANCER METASTATIC RECURRENT Post Standard therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0741681
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C2936643
2. patients who have previously treated with ≤4 chemotherapeutic regimes;
Description

Prior Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
3. patients who have previously treated with an anthracyclin antibiotics and a taxane;
Description

Anthracycline Antibiotic | taxane

Data type

boolean

Alias
UMLS CUI [1]
C0003234
UMLS CUI [2]
C0215136
4. age 18 -70 years old, ecog performance status of 0-2; life expectancy of 3 months or more;
Description

Age | ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
UMLS CUI [3]
C0023671
5. patients with at least 1 measurable target lesion determined by ct;
Description

Target Lesion Measurable Quantity CT

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
6. neuropathy ＜ctc2 degree （nci ctc4.03）within 4 weeks prior to enrollment;
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
7. basically normal results from routine blood test within 1 week prior to enrollment;
Description

Blood test normal

Data type

boolean

Alias
UMLS CUI [1]
C0919709
8. basically normal liver and renal functions within 1 week prior to enrollment;
Description

Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
9. no abnormal function for major internal organs, no heart diseases.
Description

Normal function Organ Internal Major | Heart Diseases Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4296962
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205102
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;
Description

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Molecular Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C2699893
2. patients with documented hypersensitivity to cremophor el, or patients with previous taxane treatment related sae;
Description

Hypersensitivity Cremophor EL | Taxane Related Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0056476
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1519255
3. patients of pregnancy or breast feeding;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. patients refractory to previous standard capecitabine treatment, or patients received effective standard capecitabine treatment with less than 6 months of capecitabine clearance period;
Description

Unresponsive to Capecitabine Standard therapy | Capecitabine Standard therapy Effective | Clearance of Capecitabine Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0671970
UMLS CUI [1,3]
C2936643
UMLS CUI [2,1]
C0671970
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C1280519
UMLS CUI [3,1]
C1382187
UMLS CUI [3,2]
C0671970
UMLS CUI [3,3]
C0449238
5. patients with uncontrolled brain metastasis, bone metastasis, planned recent surgery or local radiotherapy, or other emergency patients;
Description

Metastatic malignant neoplasm to brain Uncontrolled | Secondary malignant neoplasm of bone | Operative Surgical Procedures Planned | Therapeutic radiology procedure Local Planned | Emergency Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0153690
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205276
UMLS CUI [4,3]
C1301732
UMLS CUI [5,1]
C0013956
UMLS CUI [5,2]
C0030705
6. patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history;
Description

Medical condition Severe | Medical condition Uncontrolled | Cardiovascular Disease Severe | Diabetic - poor control | Uncontrolled hypertension | Communicable Disease Severe | Gastrointestinal ulceration Severe | History of psychiatric disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0421258
UMLS CUI [5]
C1868885
UMLS CUI [6,1]
C0009450
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C1963975
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0455498
UMLS CUI [8,2]
C0205318
7. patients with poor compliance;
Description

Poor compliance

Data type

boolean

Alias
UMLS CUI [1]
C0032646
8. patients not fitted for this study determined by the investigators.
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Breast Cancer NCT02253459

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast Advanced | Standard therapy Lacking | Standard therapy failed | BREAST CANCER METASTATIC RECURRENT Post Standard therapy
Item
1. histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,lacking standard therapy or being failed to or recurrent after standard therapy;
boolean
C0346993 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0741681 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C2936643 (UMLS CUI [4,3])
Prior Chemotherapy Quantity
Item
2. patients who have previously treated with ≤4 chemotherapeutic regimes;
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Anthracycline Antibiotic | taxane
Item
3. patients who have previously treated with an anthracyclin antibiotics and a taxane;
boolean
C0003234 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
Age | ECOG performance status | Life Expectancy
Item
4. age 18 -70 years old, ecog performance status of 0-2; life expectancy of 3 months or more;
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Target Lesion Measurable Quantity CT
Item
5. patients with at least 1 measurable target lesion determined by ct;
boolean
C2986546 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
Neuropathy CTCAE Grades
Item
6. neuropathy ＜ctc2 degree （nci ctc4.03）within 4 weeks prior to enrollment;
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Blood test normal
Item
7. basically normal results from routine blood test within 1 week prior to enrollment;
boolean
C0919709 (UMLS CUI [1])
Liver function | Renal function
Item
8. basically normal liver and renal functions within 1 week prior to enrollment;
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Normal function Organ Internal Major | Heart Diseases Absent
Item
9. no abnormal function for major internal organs, no heart diseases.
boolean
C4296962 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205102 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Molecular Targeted Therapy
Item
1. received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C2699893 (UMLS CUI [4])
Hypersensitivity Cremophor EL | Taxane Related Serious Adverse Event
Item
2. patients with documented hypersensitivity to cremophor el, or patients with previous taxane treatment related sae;
boolean
C0020517 (UMLS CUI [1,1])
C0056476 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
3. patients of pregnancy or breast feeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Unresponsive to Capecitabine Standard therapy | Capecitabine Standard therapy Effective | Clearance of Capecitabine Duration
Item
4. patients refractory to previous standard capecitabine treatment, or patients received effective standard capecitabine treatment with less than 6 months of capecitabine clearance period;
boolean
C0205269 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C0671970 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C1382187 (UMLS CUI [3,1])
C0671970 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
Metastatic malignant neoplasm to brain Uncontrolled | Secondary malignant neoplasm of bone | Operative Surgical Procedures Planned | Therapeutic radiology procedure Local Planned | Emergency Patients
Item
5. patients with uncontrolled brain metastasis, bone metastasis, planned recent surgery or local radiotherapy, or other emergency patients;
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
C0013956 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
Medical condition Severe | Medical condition Uncontrolled | Cardiovascular Disease Severe | Diabetic - poor control | Uncontrolled hypertension | Communicable Disease Severe | Gastrointestinal ulceration Severe | History of psychiatric disorder Uncontrolled
Item
6. patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history;
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0421258 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
C0009450 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1963975 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0455498 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
Poor compliance
Item
7. patients with poor compliance;
boolean
C0032646 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
8. patients not fitted for this study determined by the investigators.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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