ID

30610

Beskrivning

A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00951665

Länk

https://clinicaltrials.gov/show/NCT00951665

Nyckelord

Versioner (1)
  1. 2018-06-18 2018-06-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00951665

Engelsk

Eligibility Metastatic Breast Cancer NCT00951665

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented her2-positive locally advanced or metastatic breast cancer
Beskrivning

Locally advanced breast cancer HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C2348909
tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory her2 status testing and other exploratory assessments
Beskrivning

Tumor tissue sample Blocks | Unstained Specimen Quantity | HER2 Status Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1533157
UMLS CUI [2,1]
C1883469
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1512413
UMLS CUI [3,2]
C0039593
prior trastuzumab in any line of therapy (phase ib patients only)
Beskrivning

Trastuzumab Line of Therapy Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C4524693
UMLS CUI [1,3]
C1552551
no prior trastuzumab emtansine (t-dm1) or pertuzumab therapy
Beskrivning

Trastuzumab emtansine Absent | Pertuzumab Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2935436
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1328025
UMLS CUI [2,2]
C0332197
measurable or evaluable disease
Beskrivning

Measurable Disease | Evaluable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
cardiac ejection fraction >=50% by either echo or muga scan
Beskrivning

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Multiple gated acquisition scanning

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
life expectancy >= 90 days as assessed by the investigator
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving <=25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment
Beskrivning

Cancer treatment Recent Breast Carcinoma | Chemotherapy | Biological treatment | Therapy, Investigational | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Exception Hormone replacement therapy | Exception Oral Contraceptives | Exception Palliative Radiation Therapy Bone Marrow Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0949266
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0279025
UMLS CUI [7]
C1522449
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0282402
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0009905
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C3898008
UMLS CUI [10,3]
C0005953
UMLS CUI [10,4]
C0439165
history of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued
Beskrivning

Intolerance to Trastuzumab | Hypersensitivity Trastuzumab | Adverse event Relationship Trastuzumab | Intolerance to Murine protein | Hypersensitivity Murine protein | Intolerance to Murine protein Excipient | Hypersensitivity Murine protein Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0728747
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0728747
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1699668
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1699668
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C1699668
UMLS CUI [6,3]
C0015237
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C1699668
UMLS CUI [7,3]
C0015237
peripheral neuropathy of grade >= 2 per nci ctcae, version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (phase ib patients)
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
peripheral neuropathy of grade >/=1 per nci ctcae, version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (phase iia patients)
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of exposure to the following cumulative doses of anthracyclines: doxorubicin > 500 mg/m^2; liposomal doxorubicin > 900 mg/m^2; epirubicin > 720 mg/m^2
Beskrivning

Exposure to Anthracyclines Cumulative Dose | Doxorubicin Dosage | Doxorubicin liposome Dosage | Epirubicin Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C2986497
UMLS CUI [2,1]
C0013089
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0717726
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0014582
UMLS CUI [4,2]
C0178602
history of clinically significant cardiac dysfunction
Beskrivning

Cardiac dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C3277906
brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment.
Beskrivning

Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for | Therapeutic radiology procedure | Operative Surgical Procedures | Steroids | Symptom control Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0038317
UMLS CUI [7,1]
C1274136
UMLS CUI [7,2]
C0220650
history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent her2-positive breast cancer or other malignancy with a similar expected curative outcome
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception HER2-positive carcinoma of breast Treated | Exception Treatment outcome Similar Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1960398
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0085415
UMLS CUI [5,3]
C2348205
UMLS CUI [5,4]
C0006826
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Similar models

Eligibility Metastatic Breast Cancer NCT00951665

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive
Item
histologically documented her2-positive locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Tumor tissue sample Blocks | Unstained Specimen Quantity | HER2 Status Testing
Item
tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory her2 status testing and other exploratory assessments
boolean
C0475358 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C1883469 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1512413 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Trastuzumab Line of Therapy Any
Item
prior trastuzumab in any line of therapy (phase ib patients only)
boolean
C0728747 (UMLS CUI [1,1])
C4524693 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Trastuzumab emtansine Absent | Pertuzumab Absent
Item
no prior trastuzumab emtansine (t-dm1) or pertuzumab therapy
boolean
C2935436 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1328025 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Multiple gated acquisition scanning
Item
cardiac ejection fraction >=50% by either echo or muga scan
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy >= 90 days as assessed by the investigator
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Recent Breast Carcinoma | Chemotherapy | Biological treatment | Therapy, Investigational | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Exception Hormone replacement therapy | Exception Oral Contraceptives | Exception Palliative Radiation Therapy Bone Marrow Percentage
Item
fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving <=25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment
boolean
C0920425 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C1522449 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0282402 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0009905 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C3898008 (UMLS CUI [10,2])
C0005953 (UMLS CUI [10,3])
C0439165 (UMLS CUI [10,4])
Intolerance to Trastuzumab | Hypersensitivity Trastuzumab | Adverse event Relationship Trastuzumab | Intolerance to Murine protein | Hypersensitivity Murine protein | Intolerance to Murine protein Excipient | Hypersensitivity Murine protein Excipient
Item
history of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued
boolean
C1744706 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0728747 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C1699668 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1699668 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C1699668 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
C0020517 (UMLS CUI [7,1])
C1699668 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy of grade >= 2 per nci ctcae, version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (phase ib patients)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy of grade >/=1 per nci ctcae, version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (phase iia patients)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Exposure to Anthracyclines Cumulative Dose | Doxorubicin Dosage | Doxorubicin liposome Dosage | Epirubicin Dosage
Item
history of exposure to the following cumulative doses of anthracyclines: doxorubicin > 500 mg/m^2; liposomal doxorubicin > 900 mg/m^2; epirubicin > 720 mg/m^2
boolean
C0332157 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
C0013089 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0717726 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0014582 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
Cardiac dysfunction
Item
history of clinically significant cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for | Therapeutic radiology procedure | Operative Surgical Procedures | Steroids | Symptom control Metastatic malignant neoplasm to brain
Item
brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0038317 (UMLS CUI [6])
C1274136 (UMLS CUI [7,1])
C0220650 (UMLS CUI [7,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception HER2-positive carcinoma of breast Treated | Exception Treatment outcome Similar Malignant Neoplasms
Item
history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent her2-positive breast cancer or other malignancy with a similar expected curative outcome
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1960398 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0085415 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
C0006826 (UMLS CUI [5,4])
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