ID

30595

Beschreibung

A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT00875979

Link

https://clinicaltrials.gov/show/NCT00875979

Stichworte

Versionen (1)
  1. 17.06.18 17.06.18 -
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See clinicaltrials.gov

Hochgeladen am

17. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00875979

Englisch

Eligibility Metastatic Breast Cancer NCT00875979

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented human epidermal growth factor receptor 2 (her2)-positive locally advanced or metastatic breast cancer.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Trastuzumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0728747
no prior trastuzumab emtansine (t-dm1) or pertuzumab therapy.
Beschreibung

Trastuzumab emtansine Absent | Pertuzumab Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2935436
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1328025
UMLS CUI [2,2]
C0332197
measurable disease.
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
for women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
life expectancy ≥ 90 days.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
less 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; palliative radiation therapy involving ≤ 25% of marrow-bearing bone if administered ≥ 14 days prior to first study treatment.
Beschreibung

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

Datentyp

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 that resulted in trastuzumab being permanently discontinued.
Beschreibung

Intolerance to Trastuzumab | Hypersensitivity Trastuzumab | Adverse event Relationship Trastuzumab

Datentyp

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
peripheral neuropathy of grade ≥ 2.
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of clinically significant cardiac dysfunction.
Beschreibung

Cardiac dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.
Beschreibung

Systemic disease Severe Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0025517
brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of the first study treatment.
Beschreibung

Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for

Datentyp

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
history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
Beschreibung

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Treatment outcome Similar Malignant Neoplasms

Datentyp

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]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0085415
UMLS CUI [4,3]
C2348205
UMLS CUI [4,4]
C0006826
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Ähnliche Modelle

Eligibility Metastatic Breast Cancer NCT00875979

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive
Item
histologically documented human epidermal growth factor receptor 2 (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
Item
prior trastuzumab in any line of therapy.
boolean
C0728747 (UMLS CUI [1])
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
Item
measurable disease.
boolean
C1513041 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
for women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy ≥ 90 days.
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
less 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; palliative radiation therapy involving ≤ 25% of marrow-bearing bone if administered ≥ 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
Item
history of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab 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])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy of grade ≥ 2.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cardiac dysfunction
Item
history of clinically significant cardiac dysfunction.
boolean
C3277906 (UMLS CUI [1])
Systemic disease Severe Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease
Item
current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for
Item
brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of 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])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma 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, non-melanoma skin carcinoma, 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])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0085415 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C0006826 (UMLS CUI [4,4])
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