ID

37842

Description

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE); ODM derived from: https://clinicaltrials.gov/show/NCT01120184

Link

https://clinicaltrials.gov/show/NCT01120184

Keywords

Versions (1)
  1. 8/27/19 8/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01120184

English

Eligibility Breast Cancer NCT01120184

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
her2-positive breast cancer
Description

HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C1960398
histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
Description

Breast adenocarcinoma recurrent Locally | Breast adenocarcinoma metastatic | Patients Appropriate Chemotherapy | Recurrent disease Advanced Locally | Progressive Disease Advanced Locally | Excision Curative intent Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0861355
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C1697918
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0392920
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0205179
UMLS CUI [4,3]
C1517927
UMLS CUI [5,1]
C1335499
UMLS CUI [5,2]
C0205179
UMLS CUI [5,3]
C1517927
UMLS CUI [6,1]
C0728940
UMLS CUI [6,2]
C1276305
UMLS CUI [6,3]
C1272705
patients must have measurable and/or non-measurable disease which must be evaluable per recist 1.1
Description

Measurable Disease | Non-Measurable Lesion | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
UMLS CUI [3]
C1516986
ecog performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function as determined by laboratory results
Description

Organ function Laboratory Results

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C1254595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
Description

Prior Chemotherapy Secondary malignant neoplasm of female breast | Chemotherapy Secondary malignant neoplasm of female breast | Prior Chemotherapy Recurrent disease Advanced Locally | Chemotherapy Recurrent disease Advanced Locally

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0346993
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0277556
UMLS CUI [3,3]
C0205179
UMLS CUI [3,4]
C1517927
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0277556
UMLS CUI [4,3]
C0205179
UMLS CUI [4,4]
C1517927
an interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
Description

Vinca Alkaloid Cytotoxic Chemotherapy | Taxane Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0042672
UMLS CUI [1,2]
C0677881
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C0677881
hormone therapy <7 days prior to randomization
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
Description

Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C1506770
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C1506770
UMLS CUI [4,2]
C0677850
prior trastuzumab emtansine or pertuzumab therapy
Description

trastuzumab emtansine | pertuzumab

Data type

boolean

Alias
UMLS CUI [1]
C2935436
UMLS CUI [2]
C1328025
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Similar models

Eligibility Breast Cancer NCT01120184

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])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Breast adenocarcinoma recurrent Locally | Breast adenocarcinoma metastatic | Patients Appropriate Chemotherapy | Recurrent disease Advanced Locally | Progressive Disease Advanced Locally | Excision Curative intent Unsuccessful
Item
histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
boolean
C0861355 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C1697918 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C1335499 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1517927 (UMLS CUI [5,3])
C0728940 (UMLS CUI [6,1])
C1276305 (UMLS CUI [6,2])
C1272705 (UMLS CUI [6,3])
Measurable Disease | Non-Measurable Lesion | Evaluable Disease
Item
patients must have measurable and/or non-measurable disease which must be evaluable per recist 1.1
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
C1516986 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function Laboratory Results
Item
adequate organ function as determined by laboratory results
boolean
C0678852 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Secondary malignant neoplasm of female breast | Chemotherapy Secondary malignant neoplasm of female breast | Prior Chemotherapy Recurrent disease Advanced Locally | Chemotherapy Recurrent disease Advanced Locally
Item
history of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
boolean
C1514457 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C1517927 (UMLS CUI [3,4])
C0392920 (UMLS CUI [4,1])
C0277556 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
Vinca Alkaloid Cytotoxic Chemotherapy | Taxane Cytotoxic Chemotherapy
Item
an interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
boolean
C0042672 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
Hormone Therapy
Item
hormone therapy <7 days prior to randomization
boolean
C0279025 (UMLS CUI [1])
Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy
Item
trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
boolean
C0728747 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C1506770 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C1506770 (UMLS CUI [4,1])
C0677850 (UMLS CUI [4,2])
trastuzumab emtansine | pertuzumab
Item
prior trastuzumab emtansine or pertuzumab therapy
boolean
C2935436 (UMLS CUI [1])
C1328025 (UMLS CUI [2])
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