ID

13870

Beskrivning

A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00907959

Länk

https://clinicaltrials.gov/show/NCT00907959

Nyckelord

Versioner (2)
  1. 2016-03-13 2016-03-13 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

13 mars 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00907959

Engelsk

Eligibility Metastatic Breast Cancer NCT00907959

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women 18 years or older.
Beskrivning

female; age

Datatyp

boolean

Alias
UMLS CUI [1]
C0015780
UMLS CUI [2]
C0001779
2. histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer.
Beskrivning

Pathology report breast cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0807321
UMLS CUI [1,2]
C0678222
3. clinical evidence of metastatic (stage iv) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings.
Beskrivning

metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
4. availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (status on the most recent biopsy where er/pr status was documented will be used to determine hormone receptor status for stratification).
Beskrivning

estrogen receptor; progesterone receptor; biopsy tissue

Datatyp

boolean

Alias
UMLS CUI [1]
C2919271
UMLS CUI [2]
C0034833
UMLS CUI [3]
C3864006
5. at least one measurable disease site defined by recist criteria, with measurement made within 30 days of beginning study therapy. (non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. for lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation).
Beskrivning

Measurable Disease; bone lesion; leptomeningeal disease; ascites

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0238792
UMLS CUI [3]
C3160796
UMLS CUI [4]
C0003962
6. no more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (participants may have received any number of exogenous hormone therapies for stage iv disease and/or adjuvant therapy).
Beskrivning

Cytotoxic agent; exogenous hormone therapy; adjuvant therapy Carcinoma breast stage IV

Datatyp

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2]
C1516999
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C0278488
7. life expectancy of >12 weeks.
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
8. eastern cooperative oncology group performance status <2.
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
9. women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. acceptable methods of contraception are as follows:
Beskrivning

Contraception status

Datatyp

boolean

Alias
UMLS CUI [1]
C0420837
1. intrauterine device (iud)
Beskrivning

intrauterine device

Datatyp

boolean

Alias
UMLS CUI [1]
C0021900
2. hormonal birth control
Beskrivning

hormonal birth control

Datatyp

boolean

Alias
UMLS CUI [1]
C2985296
3. tubal ligation
Beskrivning

tubal ligation

Datatyp

boolean

Alias
UMLS CUI [1]
C0520483
4. partner's vasectomy
Beskrivning

vasectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0042387
5. latex condom
Beskrivning

latex condom

Datatyp

boolean

Alias
UMLS CUI [1]
C3873750
6. diaphragm
Beskrivning

diaphragm

Datatyp

boolean

Alias
UMLS CUI [1]
C0042241
7. cervical cap
Beskrivning

cervical cap

Datatyp

boolean

Alias
UMLS CUI [1]
C0007848
10. adequate organ and marrow function measured within 14 days of study treatment as defined below:
Beskrivning

organ function; bone marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0412480
absolute neutrophil count >1,500 cells/mm3 platelets >100,000 cells/mm3 hemoglobin >10 g/dl total bilirubin <1.5 mg/dl ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal or <5 x normal with documented liver metastasis alkaline phosphatase <3 x institutional upper limit of normal or <5 x normal with documented liver or bone metastasis serum creatinine <1.5 mg/dl or creatinine clearance >60 ml/min/1.73 m2 for participants with serum creatinine levels above institutional normal.
Beskrivning

absolute neutrophil count; platelets; hemoglobin; total bilirubin; alt- ast ratio; serum creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0201913
UMLS CUI [5]
C3831581
UMLS CUI [6]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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Similar models

Eligibility Metastatic Breast Cancer NCT00907959

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
female; age
Item
1. women 18 years or older.
boolean
C0015780 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Pathology report breast cancer
Item
2. histologically confirmed diagnosis of breast cancer based on pathology report of primary, regional or metastatic breast cancer.
boolean
C0807321 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
metastases
Item
3. clinical evidence of metastatic (stage iv) involvement other than bone only metastasis based on the investigator's clinical and/or radiographic findings.
boolean
C0027627 (UMLS CUI [1])
estrogen receptor; progesterone receptor; biopsy tissue
Item
4. availability of estrogen receptor and progesterone receptor status measured on biopsy tissue. (status on the most recent biopsy where er/pr status was documented will be used to determine hormone receptor status for stratification).
boolean
C2919271 (UMLS CUI [1])
C0034833 (UMLS CUI [2])
C3864006 (UMLS CUI [3])
Measurable Disease; bone lesion; leptomeningeal disease; ascites
Item
5. at least one measurable disease site defined by recist criteria, with measurement made within 30 days of beginning study therapy. (non-measurable disease includes bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions. for lesions in a previously irradiated field, the radiated lesion cannot be assessed as a measurable lesion unless growth of that lesion has been documented after radiation).
boolean
C1513041 (UMLS CUI [1])
C0238792 (UMLS CUI [2])
C3160796 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
Cytotoxic agent; exogenous hormone therapy; adjuvant therapy Carcinoma breast stage IV
Item
6. no more than 2 prior cytotoxic regimens administered for metastatic breast cancer. (participants may have received any number of exogenous hormone therapies for stage iv disease and/or adjuvant therapy).
boolean
C0304497 (UMLS CUI [1])
C1516999 (UMLS CUI [2])
C0677850 (UMLS CUI [3,1])
C0278488 (UMLS CUI [3,2])
life expectancy
Item
7. life expectancy of >12 weeks.
boolean
C0023671 (UMLS CUI [1])
ecog
Item
8. eastern cooperative oncology group performance status <2.
boolean
C1520224 (UMLS CUI [1])
Contraception status
Item
9. women of child bearing potential must agree to use two adequate methods of contraception or abstain from sexual intercourse during study treatment. acceptable methods of contraception are as follows:
boolean
C0420837 (UMLS CUI [1])
intrauterine device
Item
1. intrauterine device (iud)
boolean
C0021900 (UMLS CUI [1])
hormonal birth control
Item
2. hormonal birth control
boolean
C2985296 (UMLS CUI [1])
tubal ligation
Item
3. tubal ligation
boolean
C0520483 (UMLS CUI [1])
vasectomy
Item
4. partner's vasectomy
boolean
C0042387 (UMLS CUI [1])
latex condom
Item
5. latex condom
boolean
C3873750 (UMLS CUI [1])
diaphragm
Item
6. diaphragm
boolean
C0042241 (UMLS CUI [1])
cervical cap
Item
7. cervical cap
boolean
C0007848 (UMLS CUI [1])
organ function; bone marrow function
Item
10. adequate organ and marrow function measured within 14 days of study treatment as defined below:
boolean
C0678852 (UMLS CUI [1])
C0412480 (UMLS CUI [2])
absolute neutrophil count; platelets; hemoglobin; total bilirubin; alt- ast ratio; serum creatinine
Item
absolute neutrophil count >1,500 cells/mm3 platelets >100,000 cells/mm3 hemoglobin >10 g/dl total bilirubin <1.5 mg/dl ast(sgot)/alt(sgpt) <2.5 x institutional upper limit of normal or <5 x normal with documented liver metastasis alkaline phosphatase <3 x institutional upper limit of normal or <5 x normal with documented liver or bone metastasis serum creatinine <1.5 mg/dl or creatinine clearance >60 ml/min/1.73 m2 for participants with serum creatinine levels above institutional normal.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C3831581 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
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