ID

26313

Beschreibung

Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00739063

Link

https://clinicaltrials.gov/show/NCT00739063

Stichworte

Versionen (1)
  1. 16.10.17 16.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Oktober 2017

DOI

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Lizenz

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Eligibility Breast Cancer NCT00739063

Englisch

Eligibility Breast Cancer NCT00739063

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with histologic confirmation of metastatic (stage iv) 'triple receptor-negative' breast cancer. tissue must be available at baseline or agree to biopsy. the diagnosis of 'triple receptor-negative' breast cancer requires that either the primary tumor or a metastatic deposit be shown to be negative for estrogen receptors (er) and progesterone receptors (pr) by immunohistochemistry (ihc) and for her2/neu by ihc (i.e. a score of 0 and 1+) or fluorescent in situ hybridization (fish).
Beschreibung

Secondary malignant neoplasm of female breast Triple Negative TNM Breast tumor staging | Tissue Available | Biopsy Agreement | Primary tumor Estrogen receptor negative Immunohistochemistry | Primary tumor Progesterone receptor negative Immunohistochemistry | Primary tumor erbB-2 Receptor Negative Immunohistochemistry | Primary tumor Estrogen receptor negative FISH | Primary tumor Progesterone receptor negative FISH | Primary tumor erbB-2 Receptor Negative FISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C3539878
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0470187
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0680240
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C0279756
UMLS CUI [4,3]
C0021044
UMLS CUI [5,1]
C0677930
UMLS CUI [5,2]
C0279766
UMLS CUI [5,3]
C0021044
UMLS CUI [6,1]
C0677930
UMLS CUI [6,2]
C0069515
UMLS CUI [6,3]
C1513916
UMLS CUI [6,4]
C0021044
UMLS CUI [7,1]
C0677930
UMLS CUI [7,2]
C0279756
UMLS CUI [7,3]
C0162789
UMLS CUI [8,1]
C0677930
UMLS CUI [8,2]
C0279766
UMLS CUI [8,3]
C0162789
UMLS CUI [9,1]
C0677930
UMLS CUI [9,2]
C0069515
UMLS CUI [9,3]
C1513916
UMLS CUI [9,4]
C0162789
2. egfr protein expression and gene copy number will be evaluated on stored tissue sample at a later time. unstained slides, a block, or agreement for biopsy is required for study participation.
Beschreibung

EGFR protein expression | Gene Dosage | Unstained Specimen Required | Block Specimens Required | Biopsy agreement Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1171362
UMLS CUI [2]
C0178655
UMLS CUI [3,1]
C1883469
UMLS CUI [3,2]
C1514873
UMLS CUI [4,1]
C1533157
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C0680240
UMLS CUI [5,3]
C1514873
3. patients with metastatic breast cancer to any distant site are eligible once their disease is clinically/radiologically measurable
Beschreibung

Secondary malignant neoplasm of female breast Site Distant | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0443203
UMLS CUI [2]
C1513041
4. patients must have disease which is resistant to taxanes and anthracyclines. there is no limit to the number of previous therapies for metastatic disease.
Beschreibung

Disease Resistant to Taxane | Disease Resistant to Anthracyclines | Therapeutic procedure Quantity Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0215136
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332325
UMLS CUI [2,3]
C0282564
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0027627
5. patients are eligible if they have not had prior exposure to an egfr inhibitor (e.g.gefitinib, erlotinib) or antibody (e.g. cetuximab).
Beschreibung

Exposure to EGFR inhibitor | gefitinib | erlotinib | Exposure to EGFR Antibody | cetuximab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1443775
UMLS CUI [2]
C1122962
UMLS CUI [3]
C1135135
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C4055105
UMLS CUI [5]
C0995188
6. availability of tissue blocks and/or fresh/frozen tumor samples is an eligibility requirement in order to run the egfr ihc, fish and to confirm, if needed er, pr and her2/neu status.
Beschreibung

Availability of Tissue Block Specimens | Availability of Tumor tissue sample Fresh | Availability of Tumor tissue sample Frozen | EGFR Immunohistochemistry | EGFR FISH | Estrogen Receptor Status | Progesterone Receptor Status | HER2/Neu Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C1533157
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0475358
UMLS CUI [2,3]
C0443224
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C0475358
UMLS CUI [3,3]
C0016701
UMLS CUI [4,1]
C0034802
UMLS CUI [4,2]
C0021044
UMLS CUI [5,1]
C0034802
UMLS CUI [5,2]
C0162789
UMLS CUI [6,1]
C0034804
UMLS CUI [6,2]
C0449438
UMLS CUI [7]
C1514471
UMLS CUI [8]
C1512413
7. patients may, but are not required, to have a repeat tumor biopsy performed on study entry prior to beginning therapy and also early during study therapy for correlative studies.
Beschreibung

Neoplasm Biopsy Repeat Correlative Study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C1511524
8. patients with 'triple receptor-negative' metaplastic breast cancers are eligible if they meet the criterion of egfr overexpression.
Beschreibung

Secondary malignant neoplasm of female breast Triple Negative | EGFR Protein Overexpression Criterion Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C3539878
UMLS CUI [2,1]
C1512117
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
9. patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
10. patients must have tissue blocks available from previous primary tumor surgery or biopsy or from a previous biopsy of metastatic disease for egfr status assessment and for correlative studies
Beschreibung

Availability of Tissue Blocks Primary tumor Operative Surgical Procedures | Availability of Tissue Blocks Primary tumor Biopsy | Availability of Tissue Blocks Biopsy Neoplasm Metastasis | EGFR status assay | Correlative Study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C1533157
UMLS CUI [1,4]
C0677930
UMLS CUI [1,5]
C0543467
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0040300
UMLS CUI [2,3]
C1533157
UMLS CUI [2,4]
C0677930
UMLS CUI [2,5]
C0005558
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C0040300
UMLS CUI [3,3]
C1533157
UMLS CUI [3,4]
C0005558
UMLS CUI [3,5]
C0027627
UMLS CUI [4]
C3266973
UMLS CUI [5]
C1511524
11. patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1500/mm^3, and a platelet count >/= 100000/ mm^3. patients must have adequate liver function with a bilirubin within 1.5 times the upper limit of normal (uln). transaminases (sgpt) may be up to 5 * the uln and alkaline phosphatase may be up to 5 * uln
Beschreibung

Bone Marrow function | Granulocyte count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0857490
UMLS CUI [2,2]
C0229664
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
12. patients should have adequate renal function (serum creatinine </= 1.5 times the uln)
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
13. negative pregnancy test for a woman of childbearing potential
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
14. women of childbearing potential must use a reliable and appropriate contraceptive method during the study
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
15. patients with a performance status of 2 or better by world health organization (w.h.o.)
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with uncompensated congestive cardiac failure are not eligible
Beschreibung

Congestive heart failure Uncompensated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205433
2. patients with a myocardial infarction in the previous 12 months are not eligible
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
3. patients with central nervous system (cns) metastases are not eligible
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
4. patients with an organ allograft
Beschreibung

Organ Allograft

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0450127
5. patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
Beschreibung

Communicable Disease Serious Protocol Compliance Limited | Comorbidity Serious Protocol Compliance Limited | Angina, Unstable | Cardiac Arrhythmia | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0439801
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0004936
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Ähnliche Modelle

Eligibility Breast Cancer NCT00739063

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast Triple Negative TNM Breast tumor staging | Tissue Available | Biopsy Agreement | Primary tumor Estrogen receptor negative Immunohistochemistry | Primary tumor Progesterone receptor negative Immunohistochemistry | Primary tumor erbB-2 Receptor Negative Immunohistochemistry | Primary tumor Estrogen receptor negative FISH | Primary tumor Progesterone receptor negative FISH | Primary tumor erbB-2 Receptor Negative FISH
Item
1. patients with histologic confirmation of metastatic (stage iv) 'triple receptor-negative' breast cancer. tissue must be available at baseline or agree to biopsy. the diagnosis of 'triple receptor-negative' breast cancer requires that either the primary tumor or a metastatic deposit be shown to be negative for estrogen receptors (er) and progesterone receptors (pr) by immunohistochemistry (ihc) and for her2/neu by ihc (i.e. a score of 0 and 1+) or fluorescent in situ hybridization (fish).
boolean
C0346993 (UMLS CUI [1,1])
C3539878 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C1292533 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0680240 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4,1])
C0279756 (UMLS CUI [4,2])
C0021044 (UMLS CUI [4,3])
C0677930 (UMLS CUI [5,1])
C0279766 (UMLS CUI [5,2])
C0021044 (UMLS CUI [5,3])
C0677930 (UMLS CUI [6,1])
C0069515 (UMLS CUI [6,2])
C1513916 (UMLS CUI [6,3])
C0021044 (UMLS CUI [6,4])
C0677930 (UMLS CUI [7,1])
C0279756 (UMLS CUI [7,2])
C0162789 (UMLS CUI [7,3])
C0677930 (UMLS CUI [8,1])
C0279766 (UMLS CUI [8,2])
C0162789 (UMLS CUI [8,3])
C0677930 (UMLS CUI [9,1])
C0069515 (UMLS CUI [9,2])
C1513916 (UMLS CUI [9,3])
C0162789 (UMLS CUI [9,4])
EGFR protein expression | Gene Dosage | Unstained Specimen Required | Block Specimens Required | Biopsy agreement Required
Item
2. egfr protein expression and gene copy number will be evaluated on stored tissue sample at a later time. unstained slides, a block, or agreement for biopsy is required for study participation.
boolean
C0034802 (UMLS CUI [1,1])
C1171362 (UMLS CUI [1,2])
C0178655 (UMLS CUI [2])
C1883469 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1533157 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0005558 (UMLS CUI [5,1])
C0680240 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
Secondary malignant neoplasm of female breast Site Distant | Measurable Disease
Item
3. patients with metastatic breast cancer to any distant site are eligible once their disease is clinically/radiologically measurable
boolean
C0346993 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0443203 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2])
Disease Resistant to Taxane | Disease Resistant to Anthracyclines | Therapeutic procedure Quantity Neoplasm Metastasis
Item
4. patients must have disease which is resistant to taxanes and anthracyclines. there is no limit to the number of previous therapies for metastatic disease.
boolean
C0012634 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0215136 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C0282564 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
Exposure to EGFR inhibitor | gefitinib | erlotinib | Exposure to EGFR Antibody | cetuximab
Item
5. patients are eligible if they have not had prior exposure to an egfr inhibitor (e.g.gefitinib, erlotinib) or antibody (e.g. cetuximab).
boolean
C0332157 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
C1122962 (UMLS CUI [2])
C1135135 (UMLS CUI [3])
C0332157 (UMLS CUI [4,1])
C4055105 (UMLS CUI [4,2])
C0995188 (UMLS CUI [5])
Availability of Tissue Block Specimens | Availability of Tumor tissue sample Fresh | Availability of Tumor tissue sample Frozen | EGFR Immunohistochemistry | EGFR FISH | Estrogen Receptor Status | Progesterone Receptor Status | HER2/Neu Status
Item
6. availability of tissue blocks and/or fresh/frozen tumor samples is an eligibility requirement in order to run the egfr ihc, fish and to confirm, if needed er, pr and her2/neu status.
boolean
C0470187 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C1533157 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C0475358 (UMLS CUI [2,2])
C0443224 (UMLS CUI [2,3])
C0470187 (UMLS CUI [3,1])
C0475358 (UMLS CUI [3,2])
C0016701 (UMLS CUI [3,3])
C0034802 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
C0034802 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
C0034804 (UMLS CUI [6,1])
C0449438 (UMLS CUI [6,2])
C1514471 (UMLS CUI [7])
C1512413 (UMLS CUI [8])
Neoplasm Biopsy Repeat Correlative Study
Item
7. patients may, but are not required, to have a repeat tumor biopsy performed on study entry prior to beginning therapy and also early during study therapy for correlative studies.
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C1511524 (UMLS CUI [1,4])
Secondary malignant neoplasm of female breast Triple Negative | EGFR Protein Overexpression Criterion Fulfill
Item
8. patients with 'triple receptor-negative' metaplastic breast cancers are eligible if they meet the criterion of egfr overexpression.
boolean
C0346993 (UMLS CUI [1,1])
C3539878 (UMLS CUI [1,2])
C1512117 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Informed Consent
Item
9. patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
boolean
C0021430 (UMLS CUI [1])
Availability of Tissue Blocks Primary tumor Operative Surgical Procedures | Availability of Tissue Blocks Primary tumor Biopsy | Availability of Tissue Blocks Biopsy Neoplasm Metastasis | EGFR status assay | Correlative Study
Item
10. patients must have tissue blocks available from previous primary tumor surgery or biopsy or from a previous biopsy of metastatic disease for egfr status assessment and for correlative studies
boolean
C0470187 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C1533157 (UMLS CUI [1,3])
C0677930 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
C0470187 (UMLS CUI [2,1])
C0040300 (UMLS CUI [2,2])
C1533157 (UMLS CUI [2,3])
C0677930 (UMLS CUI [2,4])
C0005558 (UMLS CUI [2,5])
C0470187 (UMLS CUI [3,1])
C0040300 (UMLS CUI [3,2])
C1533157 (UMLS CUI [3,3])
C0005558 (UMLS CUI [3,4])
C0027627 (UMLS CUI [3,5])
C3266973 (UMLS CUI [4])
C1511524 (UMLS CUI [5])
Bone Marrow function | Granulocyte count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
11. patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1500/mm^3, and a platelet count >/= 100000/ mm^3. patients must have adequate liver function with a bilirubin within 1.5 times the upper limit of normal (uln). transaminases (sgpt) may be up to 5 * the uln and alkaline phosphatase may be up to 5 * uln
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0857490 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Renal function | Creatinine measurement, serum
Item
12. patients should have adequate renal function (serum creatinine </= 1.5 times the uln)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative
Item
13. negative pregnancy test for a woman of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
14. women of childbearing potential must use a reliable and appropriate contraceptive method during the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
WHO performance status scale
Item
15. patients with a performance status of 2 or better by world health organization (w.h.o.)
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Congestive heart failure Uncompensated
Item
1. patients with uncompensated congestive cardiac failure are not eligible
boolean
C0018802 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
Myocardial Infarction
Item
2. patients with a myocardial infarction in the previous 12 months are not eligible
boolean
C0027051 (UMLS CUI [1])
CNS metastases
Item
3. patients with central nervous system (cns) metastases are not eligible
boolean
C0686377 (UMLS CUI [1])
Organ Allograft
Item
4. patients with an organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0450127 (UMLS CUI [1,2])
Communicable Disease Serious Protocol Compliance Limited | Comorbidity Serious Protocol Compliance Limited | Angina, Unstable | Cardiac Arrhythmia | Mental disorders
Item
5. patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
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