ID

38232

Beskrivning

Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01045304

Länk

https://clinicaltrials.gov/show/NCT01045304

Nyckelord

Versioner (1)
  1. 2019-09-30 2019-09-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer, Metastatic NCT01045304

Engelsk

Eligibility Breast Cancer, Metastatic NCT01045304

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented breast cancer (either primary or metastatic site) that is er (estrogen receptor)-negative, pgr (progesterone receptor)-negative ( <10% tumor staining by immunohistochemistry [ihc]) and her2 (human epidermal growth factor 2) non-overexpressing by ihc (0,1+) or, ihc 2+ and fish (fluorescence in situ hybridization) negative.
Beskrivning

Breast Carcinoma Primary tumor site | Secondary malignant neoplasm of female breast | Estrogen receptor negative Immunohistochemistry | Progesterone receptor negative Immunohistochemistry | HER2 Protein Overexpression Absent Immunohistochemistry | HER2 Protein Overexpression Absent FISH Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0475447
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C0279756
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C0279766
UMLS CUI [4,2]
C0021044
UMLS CUI [5,1]
C1515560
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0021044
UMLS CUI [6,1]
C1515560
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0162789
UMLS CUI [6,4]
C1513916
metastatic breast cancer with measurable disease by the revised guideline for response evaluation criteria in solid tumors version 1.1 (recist 1.1 criteria);
Beskrivning

Secondary malignant neoplasm of female breast | Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C1513041
prior treatment that includes:
Beskrivning

Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
never having received anticancer therapy for metastatic disease or
Beskrivning

Cancer treatment Absent Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027627
having received 1 or 2 prior chemotherapy regimens in the metastatic setting (prior neo-adjuvant/adjuvant systemic therapy is considered as a prior chemotherapy if the first relapse occurred less than one year after the last treatment administration).
Beskrivning

Prior Chemotherapy Quantity Neoplasm Metastasis | Neoadjuvant Therapy Systemic | Adjuvant therapy Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C0205373
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with gemcitabine, carboplatin, cisplatin or any parp inhibitor;
Beskrivning

gemcitabine | Carboplatin | Cisplatin | PARP Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0045093
UMLS CUI [2]
C0079083
UMLS CUI [3]
C0008838
UMLS CUI [4]
C1882413
bone metastasis as only disease location (except for bone metastasis with measurable soft tissue component);
Beskrivning

Secondary malignant neoplasm of bone | Disease Location only | Exception Soft tissue Component Measurable

Datatyp

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0225317
UMLS CUI [3,3]
C1705248
UMLS CUI [3,4]
C1513040
major medical conditions that might affect study participation e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease.
Beskrivning

Medical condition Major Affecting Study Subject Participation Status | Pulmonary Dysfunction Uncontrolled | Renal dysfunction Uncontrolled | Liver Dysfunction Uncontrolled | Communicable Disease Uncontrolled | Heart Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C1709770
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C3279454
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0086565
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C0205318
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status | Considerations Additional

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Breast Cancer, Metastatic NCT01045304

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Primary tumor site | Secondary malignant neoplasm of female breast | Estrogen receptor negative Immunohistochemistry | Progesterone receptor negative Immunohistochemistry | HER2 Protein Overexpression Absent Immunohistochemistry | HER2 Protein Overexpression Absent FISH Negative
Item
histologically documented breast cancer (either primary or metastatic site) that is er (estrogen receptor)-negative, pgr (progesterone receptor)-negative ( <10% tumor staining by immunohistochemistry [ihc]) and her2 (human epidermal growth factor 2) non-overexpressing by ihc (0,1+) or, ihc 2+ and fish (fluorescence in situ hybridization) negative.
boolean
C0678222 (UMLS CUI [1,1])
C0475447 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
C0279756 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0279766 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
C1515560 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0021044 (UMLS CUI [5,3])
C1515560 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0162789 (UMLS CUI [6,3])
C1513916 (UMLS CUI [6,4])
Secondary malignant neoplasm of female breast | Measurable Disease
Item
metastatic breast cancer with measurable disease by the revised guideline for response evaluation criteria in solid tumors version 1.1 (recist 1.1 criteria);
boolean
C0346993 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Prior Therapy
Item
prior treatment that includes:
boolean
C1514463 (UMLS CUI [1])
Cancer treatment Absent Neoplasm Metastasis
Item
never having received anticancer therapy for metastatic disease or
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Prior Chemotherapy Quantity Neoplasm Metastasis | Neoadjuvant Therapy Systemic | Adjuvant therapy Systemic
Item
having received 1 or 2 prior chemotherapy regimens in the metastatic setting (prior neo-adjuvant/adjuvant systemic therapy is considered as a prior chemotherapy if the first relapse occurred less than one year after the last treatment administration).
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
gemcitabine | Carboplatin | Cisplatin | PARP Inhibitors
Item
prior treatment with gemcitabine, carboplatin, cisplatin or any parp inhibitor;
boolean
C0045093 (UMLS CUI [1])
C0079083 (UMLS CUI [2])
C0008838 (UMLS CUI [3])
C1882413 (UMLS CUI [4])
Secondary malignant neoplasm of bone | Disease Location only | Exception Soft tissue Component Measurable
Item
bone metastasis as only disease location (except for bone metastasis with measurable soft tissue component);
boolean
C0153690 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0225317 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C1513040 (UMLS CUI [3,4])
Medical condition Major Affecting Study Subject Participation Status | Pulmonary Dysfunction Uncontrolled | Renal dysfunction Uncontrolled | Liver Dysfunction Uncontrolled | Communicable Disease Uncontrolled | Heart Disease Uncontrolled
Item
major medical conditions that might affect study participation e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease.
boolean
C3843040 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1709770 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C3279454 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0086565 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0018799 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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