ID

38053

Description

A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in First Line in Patients With Metastatic or Locally Advanced HER2-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01565083

Link

https://clinicaltrials.gov/show/NCT01565083

Keywords

Versions (1)
  1. 9/12/19 9/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01565083

English

Eligibility Breast Cancer NCT01565083

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
Description

Breast adenocarcinoma | Neoplasm Metastasis | Advanced disease Locally | Excision Curative Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0679246
UMLS CUI [3,2]
C1517927
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C1276305
UMLS CUI [4,3]
C1272705
her2-positive as assessed by local laboratory on primary or metastatic tumor
Description

Primary tumor HER2 Positive | Neoplasm Metastasis HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C2348909
at least one measurable lesion and/or non-measurable disease evaluable according to recist version 1.1 criteria
Description

Measurable Disease Evaluable Quantity | Non-Measurable Lesion Evaluable Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1516986
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1334988
UMLS CUI [2,2]
C1516986
UMLS CUI [2,3]
C1265611
eastern cooperative oncology group (ecog) performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction (lvef) of at least 55%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
life expectancy of at least 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced setting
Description

Cancer treatment Systemic | Exception Hormone Therapy | Neoplasm Metastasis | Advanced disease Locally

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
UMLS CUI [3]
C0027627
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C1517927
previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Description

HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational | Therapeutic procedure Breast Carcinoma | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C2267079
UMLS CUI [2,1]
C2267079
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C0677850
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1506770
UMLS CUI [5,3]
C0677850
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0728747
UMLS CUI [6,3]
C0600558
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1506770
UMLS CUI [7,3]
C0600558
disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Description

Disease Progression | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C1506770
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0600558
UMLS CUI [5,1]
C1506770
UMLS CUI [5,2]
C0600558
disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
Description

Interval Disease Free | Completion Systemic therapy Adjuvant | Completion Neoadjuvant systemic therapy | Exception Hormone Therapy | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C1522673
UMLS CUI [3,1]
C0205197
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C1515119
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279025
UMLS CUI [5]
C0277556
history of persistent grade 2 or higher (nci-ctc version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Description

Toxicity Hematological Persistent CTCAE Grades | Toxicity Due to Adjuvant therapy | Toxicity Due to Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0205322
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0677850
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0600558
radiographic evidence of central nervous system (cns) metastases
Description

CNS metastases Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0034571
current peripheral neuropathy of grade 3 or greater
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the patients at high risk for treatment -related complications
Description

Comorbidity Serious Uncontrolled | Medical contraindication Investigational New Drugs | High risk Complications of treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0679861
inadequate hematologic, liver or renal function
Description

Hematologic function Inadequate | Renal function Inadequate | Liver function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205412
uncontrolled hypertension or clinically significant cardiovascular disease
Description

Uncontrolled hypertension | Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0007222
hepatitis b, hepatitis c or hiv infection
Description

Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
Description

Adrenal Cortex Hormones daily chronic | Methylprednisolone U/day | Equivalent | Exception Inhaled steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0025815
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2065041
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Similar models

Eligibility Breast Cancer NCT01565083

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma | Neoplasm Metastasis | Advanced disease Locally | Excision Curative Unsuccessful
Item
histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
boolean
C0858252 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0679246 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0728940 (UMLS CUI [4,1])
C1276305 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
Primary tumor HER2 Positive | Neoplasm Metastasis HER2 Positive
Item
her2-positive as assessed by local laboratory on primary or metastatic tumor
boolean
C0677930 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Measurable Disease Evaluable Quantity | Non-Measurable Lesion Evaluable Quantity
Item
at least one measurable lesion and/or non-measurable disease evaluable according to recist version 1.1 criteria
boolean
C1513041 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1334988 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of at least 55%
boolean
C0428772 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic | Exception Hormone Therapy | Neoplasm Metastasis | Advanced disease Locally
Item
previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced setting
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
C0679246 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational | Therapeutic procedure Breast Carcinoma | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy
Item
previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
boolean
C2267079 (UMLS CUI [1])
C2267079 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C0677850 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1506770 (UMLS CUI [5,2])
C0677850 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
C0600558 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1506770 (UMLS CUI [7,2])
C0600558 (UMLS CUI [7,3])
Disease Progression | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy
Item
disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1506770 (UMLS CUI [5,1])
C0600558 (UMLS CUI [5,2])
Interval Disease Free | Completion Systemic therapy Adjuvant | Completion Neoadjuvant systemic therapy | Exception Hormone Therapy | Recurrent disease
Item
disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
boolean
C1272706 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0205197 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C1522673 (UMLS CUI [2,3])
C0205197 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C1515119 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5])
Toxicity Hematological Persistent CTCAE Grades | Toxicity Due to Adjuvant therapy | Toxicity Due to Neoadjuvant Therapy
Item
history of persistent grade 2 or higher (nci-ctc version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
boolean
C0600688 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0677850 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
CNS metastases Radiography
Item
radiographic evidence of central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades
Item
current peripheral neuropathy of grade 3 or greater
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
history of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Comorbidity Serious Uncontrolled | Medical contraindication Investigational New Drugs | High risk Complications of treatment
Item
serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the patients at high risk for treatment -related complications
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0679861 (UMLS CUI [3,2])
Hematologic function Inadequate | Renal function Inadequate | Liver function Inadequate
Item
inadequate hematologic, liver or renal function
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Uncontrolled hypertension | Cardiovascular Disease
Item
uncontrolled hypertension or clinically significant cardiovascular disease
boolean
C1868885 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Hepatitis B | Hepatitis C | HIV Infection
Item
hepatitis b, hepatitis c or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Adrenal Cortex Hormones daily chronic | Methylprednisolone U/day | Equivalent | Exception Inhaled steroids
Item
current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
boolean
C0001617 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0025815 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C2065041 (UMLS CUI [4,2])
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