ID

37732

Beschreibung

Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01204125

Link

https://clinicaltrials.gov/show/NCT01204125

Stichworte

Versionen (1)
  1. 20.08.19 20.08.19 -
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See clinicaltrials.gov

Hochgeladen am

20. August 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer Female NCT01204125

Englisch

Eligibility Breast Cancer Female NCT01204125

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed stage ii-iiia invasive breast cancer eligible for definitive surgery and estrogen receptor (er)-negative, progesterone receptor (pgr)-negative and human epidermal growth factor receptor 2 (her2) non-overexpressing by immunohistochemistry (ihc) (0+, 1+) or fluorescence in situ hybridization (fish negative, ratio <1.8) or ihc (2+, 3+) /fish-negative.
Beschreibung

Invasive carcinoma of breast TNM Breast tumor staging | Eligibility Operative Surgical Procedure | Estrogen receptor negative | Progesterone receptor negative | HER2 Protein Overexpression Absent Immunohistochemistry | HER2 Protein Overexpression Absent FISH | FISH Negative | Ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C0279756
UMLS CUI [4]
C0279766
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 [7,1]
C0162789
UMLS CUI [7,2]
C1513916
UMLS CUI [8]
C1261161
the primary tumor must be > 2cm in diameter measured by physical examination and mammography (mandatory) plus either echography or magnetic resonance imaging (mri)
Beschreibung

Primary tumor Diameter Physical Examination | Primary tumor Diameter Mammography | Primary tumor Diameter Echography | Primary tumor Diameter MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0024671
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0041618
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0024485
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow reserve
Beschreibung

Bone Marrow Mature Neutrophils Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
adequate liver and renal function.
Beschreibung

Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
age > or = 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior treatment for primary breast cancer.
Beschreibung

Prior Therapy Breast Carcinoma Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205225
bilateral or multicentric breast cancer.
Beschreibung

Bilateral breast cancer | Multicentric Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C2986664
other primary tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Beschreibung

Cancer Other | Exception Basal cell carcinoma Limited Controlled | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C2911690
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
pre-existing peripheral neuropathy grade > or = 2 as per national cancer institute common toxicity criteria for adverse event (nci ctcae) at randomization.
Beschreibung

Peripheral Neuropathy Pre-existing CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
any history of medical (e.g., cardiovascular, uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results
Beschreibung

Dysfunction Cardiovascular | Pulmonary Dysfunction Uncontrolled | Renal dysfunction | Liver Dysfunction | Communicable Disease Uncontrolled | Mental condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental condition Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Mental condition Interferes with Interpretation Research results | Laboratory test result abnormal Interferes with Interpretation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3887504
UMLS CUI [1,2]
C3887460
UMLS CUI [2,1]
C1709770
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C3279454
UMLS CUI [4]
C0086565
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C0438215
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0013230
UMLS CUI [8,3]
C1444641
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C0013230
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C3840291
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0459471
UMLS CUI [10,4]
C0683954
UMLS CUI [11,1]
C0438215
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
pregnancy or breastfeeding women.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential (<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug.
Beschreibung

Childbearing Potential Contraceptive methods Absent | Contraceptive methods Except Hormonal contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2985296
requirement for radiation therapy concurrent with study anticancer treatment. patients who require breast or chest wall radiation therapy after surgery are eligible.
Beschreibung

Therapeutic radiology procedure Required | In addition to Cancer treatment Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0332287
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C1517586
known hypersensitivity to any of the study drugs or excipients
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status | Considerations Additional

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Ähnliche Modelle

Eligibility Breast Cancer Female NCT01204125

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast TNM Breast tumor staging | Eligibility Operative Surgical Procedure | Estrogen receptor negative | Progesterone receptor negative | HER2 Protein Overexpression Absent Immunohistochemistry | HER2 Protein Overexpression Absent FISH | FISH Negative | Ratio measurement
Item
histologically confirmed stage ii-iiia invasive breast cancer eligible for definitive surgery and estrogen receptor (er)-negative, progesterone receptor (pgr)-negative and human epidermal growth factor receptor 2 (her2) non-overexpressing by immunohistochemistry (ihc) (0+, 1+) or fluorescence in situ hybridization (fish negative, ratio <1.8) or ihc (2+, 3+) /fish-negative.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0279756 (UMLS CUI [3])
C0279766 (UMLS CUI [4])
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])
C0162789 (UMLS CUI [7,1])
C1513916 (UMLS CUI [7,2])
C1261161 (UMLS CUI [8])
Primary tumor Diameter Physical Examination | Primary tumor Diameter Mammography | Primary tumor Diameter Echography | Primary tumor Diameter MRI
Item
the primary tumor must be > 2cm in diameter measured by physical examination and mammography (mandatory) plus either echography or magnetic resonance imaging (mri)
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0024671 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
C0677930 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Mature Neutrophils Present
Item
adequate bone marrow reserve
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
Liver function | Renal function
Item
adequate liver and renal function.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Age
Item
age > or = 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Breast Carcinoma Primary
Item
any prior treatment for primary breast cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Bilateral breast cancer | Multicentric Breast Carcinoma
Item
bilateral or multicentric breast cancer.
boolean
C0281267 (UMLS CUI [1])
C2986664 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Limited Controlled | Exception Carcinoma in situ of uterine cervix
Item
other primary tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C2911690 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
pre-existing peripheral neuropathy grade > or = 2 as per national cancer institute common toxicity criteria for adverse event (nci ctcae) at randomization.
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Dysfunction Cardiovascular | Pulmonary Dysfunction Uncontrolled | Renal dysfunction | Liver Dysfunction | Communicable Disease Uncontrolled | Mental condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental condition Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Mental condition Interferes with Interpretation Research results | Laboratory test result abnormal Interferes with Interpretation Research results
Item
any history of medical (e.g., cardiovascular, uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results
boolean
C3887504 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C1709770 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C3279454 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C3840291 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0438215 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0438215 (UMLS CUI [9,1])
C0013230 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C3840291 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0459471 (UMLS CUI [10,3])
C0683954 (UMLS CUI [10,4])
C0438215 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Contraceptive methods Except Hormonal contraception
Item
women of childbearing potential (<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0700589 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2985296 (UMLS CUI [2,3])
Therapeutic radiology procedure Required | In addition to Cancer treatment Investigational
Item
requirement for radiation therapy concurrent with study anticancer treatment. patients who require breast or chest wall radiation therapy after surgery are eligible.
boolean
C1522449 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0332287 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients
Item
known hypersensitivity to any of the study drugs or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
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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