ID

38026

Description

A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Patients With Hormone Receptor-Positive, Metastatic HER2-positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01491737

Link

https://clinicaltrials.gov/show/NCT01491737

Keywords

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

See clinicaltrials.gov

Uploaded on

September 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01491737

English

Eligibility Breast Cancer NCT01491737

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Gender | Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0001779
patients with her2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C2348909
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C0019929
UMLS CUI [2,4]
C1514241
UMLS CUI [3,1]
C3495949
UMLS CUI [3,2]
C2348909
UMLS CUI [4,1]
C3495949
UMLS CUI [4,2]
C0019929
UMLS CUI [4,3]
C1514241
post-menopausal status over 1 year
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
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
hormone-receptor positive defined as er-positive and/or pgr-positive
Description

Hormone Receptor Positive Definition | Estrogen receptor positive | Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1704788
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
at least one measurable lesion and/or non-measurable disease according to response evaluation criteria in solid tumors (recist)
Description

Measurable lesion Quantity | Non-Measurable Lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1334988
UMLS CUI [2,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with anti-her2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
Description

Prior Therapy Breast Carcinoma | HER2 Receptor Antagonist | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C2267079
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0728747
UMLS CUI [3,3]
C0600558
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1506770
UMLS CUI [4,3]
C0600558
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0728747
UMLS CUI [5,3]
C0677850
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1506770
UMLS CUI [6,3]
C0677850
disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
Description

Disease Progression During Adjuvant therapy | trastuzumab | lapatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0677850
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1506770
disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
Description

Interval Disease Free | Completion Systemic therapy Adjuvant | Exception Hormone Therapy | Completion Neoadjuvant Systemic therapy | Disease recurrence

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]
C1705847
UMLS CUI [3,2]
C0279025
UMLS CUI [4,1]
C0205197
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C1515119
UMLS CUI [5]
C0679254
other malignancies in </= 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
clinical or radiographic evidence of central nervous system (cns) metastases or significant cv disease
Description

CNS metastases | Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0007222
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Similar models

Eligibility Breast Cancer NCT01491737

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Adult | Age
Item
female adult patients, >/=18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Secondary malignant neoplasm of female breast Advanced HER2 Positive | Secondary malignant neoplasm of female breast Advanced Hormone Receptor Positive | Locally advanced breast cancer HER2 Positive | Locally advanced breast cancer Hormone Receptor Positive
Item
patients with her2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2348909 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0019929 (UMLS CUI [2,3])
C1514241 (UMLS CUI [2,4])
C3495949 (UMLS CUI [3,1])
C2348909 (UMLS CUI [3,2])
C3495949 (UMLS CUI [4,1])
C0019929 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
Postmenopausal state
Item
post-menopausal status over 1 year
boolean
C0232970 (UMLS CUI [1])
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])
Hormone Receptor Positive Definition | Estrogen receptor positive | Progesterone receptor positive
Item
hormone-receptor positive defined as er-positive and/or pgr-positive
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
Measurable lesion Quantity | Non-Measurable Lesion Quantity
Item
at least one measurable lesion and/or non-measurable disease according to response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Breast Carcinoma | HER2 Receptor Antagonist | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy
Item
previous treatment with anti-her2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C2267079 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1506770 (UMLS CUI [4,2])
C0600558 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0728747 (UMLS CUI [5,2])
C0677850 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1506770 (UMLS CUI [6,2])
C0677850 (UMLS CUI [6,3])
Disease Progression During Adjuvant therapy | trastuzumab | lapatinib
Item
disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
boolean
C0242656 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
Interval Disease Free | Completion Systemic therapy Adjuvant | Exception Hormone Therapy | Completion Neoadjuvant Systemic therapy | Disease recurrence
Item
disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 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])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C0205197 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1515119 (UMLS CUI [4,3])
C0679254 (UMLS CUI [5])
Cancer Other
Item
other malignancies in </= 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
boolean
C1707251 (UMLS CUI [1])
CNS metastases | Cardiovascular Disease
Item
clinical or radiographic evidence of central nervous system (cns) metastases or significant cv disease
boolean
C0686377 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
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