ID

38239

Beskrivning

A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02131064

Länk

https://clinicaltrials.gov/show/NCT02131064

Nyckelord

Versioner (1)
  1. 2019-10-01 2019-10-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02131064

Engelsk

Eligibility Breast Cancer NCT02131064

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >/= 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed invasive breast cancer with a primary tumor size of > 2 cm
Beskrivning

Invasive carcinoma of breast | Primary tumor size

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0456389
her2-positive breast cancer
Beskrivning

HER2-positive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C1960398
patients with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) if all sampled lesions are centrally confirmed as her2-positive
Beskrivning

Multifocal tumor | Lesion All HER2 Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C1302461
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C2348909
stage at presentation: ct2-ct4, cn0-cn3, cm0
Beskrivning

TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0474926
known hormone receptor status of the primary tumor
Beskrivning

Primary tumor | Hormone Receptor Status Known

Datatyp

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0205309
patient agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
Beskrivning

Agreement Mastectomy | Agreement Breast-Conserving Surgery | Status post Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0024881
UMLS CUI [2,1]
C0680240
UMLS CUI [2,2]
C0917927
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0600558
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
baseline lvef >55% measured by echocardiogram (echo) or multiple-gated acquisition (muga)
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
effective contraception as defined by protocol
Beskrivning

Contraceptive methods | Definition Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C1704788
UMLS CUI [2,2]
C2348563
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage iv (metastatic) breast cancer
Beskrivning

Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
patients who have received prior anti-cancer therapy for breast cancer except those patients with a history of breast lobular carcinoma in situ (lcis) that was surgically managed or ductal carcinoma in situ (dcis) treated exclusively with mastectomy. in case of prior history of lcis/dcis, >5 years must have passed from surgery until diagnosis of current breast cancer
Beskrivning

Cancer treatment Breast Carcinoma | Exception Surgical Management Lobular carcinoma in situ of breast | Exception Mastectomy DCIS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1515089
UMLS CUI [2,3]
C0279563
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024881
UMLS CUI [3,3]
C0007124
patients with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
Beskrivning

Multicentric Breast Carcinoma | Bilateral breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C2986664
UMLS CUI [2]
C0281267
patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Beskrivning

Incisional biopsy Primary tumor | Excision biopsy Primary tumor | Incisional biopsy Axillary lymph nodes | Excision biopsy Axillary lymph nodes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184922
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0184921
UMLS CUI [2,2]
C0677930
UMLS CUI [3,1]
C0184922
UMLS CUI [3,2]
C0729594
UMLS CUI [4,1]
C0184921
UMLS CUI [4,2]
C0729594
axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy.
Beskrivning

Excision of axillary lymph nodes | Sentinel Lymph Node Positive | Status pre- Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0193867
UMLS CUI [2,1]
C1522495
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0600558
history of concurrent or previous non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. a patient with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years
Beskrivning

Malignant Neoplasms | Exception Breast Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Colon Carcinoma In situ Treated | Exception Carcinoma in situ of skin Treated | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007099
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699790
UMLS CUI [6,3]
C0444498
UMLS CUI [6,4]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0154073
UMLS CUI [7,3]
C1522326
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0012634
UMLS CUI [8,3]
C0332296
UMLS CUI [8,4]
C0449238
treatment with any investigational drug within 28 days prior to randomization
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
current national cancer institute common terminology criteria for adverse events (nci ctcae) v4.03 grade >/= 2 peripheral neuropathy
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study
Beskrivning

Medical condition At risk Patient safety | Medical condition compromises Completion of clinical trial | Surgery At risk Patient safety | Surgery compromises Completion of clinical trial | Findings At risk Patient safety | Findings compromise Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0038895
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0038895
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C2732579
UMLS CUI [5,1]
C2607943
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C2607943
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C2732579
pregnancy or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02131064

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast | Primary tumor size
Item
histologically confirmed invasive breast cancer with a primary tumor size of > 2 cm
boolean
C0853879 (UMLS CUI [1])
C0677930 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Multifocal tumor | Lesion All HER2 Positive
Item
patients with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) if all sampled lesions are centrally confirmed as her2-positive
boolean
C1302461 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C2348909 (UMLS CUI [2,3])
TNM Breast tumor staging
Item
stage at presentation: ct2-ct4, cn0-cn3, cm0
boolean
C0474926 (UMLS CUI [1])
Primary tumor | Hormone Receptor Status Known
Item
known hormone receptor status of the primary tumor
boolean
C0677930 (UMLS CUI [1])
C0019929 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Agreement Mastectomy | Agreement Breast-Conserving Surgery | Status post Neoadjuvant Therapy
Item
patient agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
boolean
C0680240 (UMLS CUI [1,1])
C0024881 (UMLS CUI [1,2])
C0680240 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
baseline lvef >55% measured by echocardiogram (echo) or multiple-gated acquisition (muga)
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Contraceptive methods | Definition Study Protocol
Item
effective contraception as defined by protocol
boolean
C0700589 (UMLS CUI [1])
C1704788 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
stage iv (metastatic) breast cancer
boolean
C0346993 (UMLS CUI [1])
Cancer treatment Breast Carcinoma | Exception Surgical Management Lobular carcinoma in situ of breast | Exception Mastectomy DCIS
Item
patients who have received prior anti-cancer therapy for breast cancer except those patients with a history of breast lobular carcinoma in situ (lcis) that was surgically managed or ductal carcinoma in situ (dcis) treated exclusively with mastectomy. in case of prior history of lcis/dcis, >5 years must have passed from surgery until diagnosis of current breast cancer
boolean
C0920425 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1515089 (UMLS CUI [2,2])
C0279563 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0024881 (UMLS CUI [3,2])
C0007124 (UMLS CUI [3,3])
Multicentric Breast Carcinoma | Bilateral breast cancer
Item
patients with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
boolean
C2986664 (UMLS CUI [1])
C0281267 (UMLS CUI [2])
Incisional biopsy Primary tumor | Excision biopsy Primary tumor | Incisional biopsy Axillary lymph nodes | Excision biopsy Axillary lymph nodes
Item
patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
boolean
C0184922 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0184921 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0184922 (UMLS CUI [3,1])
C0729594 (UMLS CUI [3,2])
C0184921 (UMLS CUI [4,1])
C0729594 (UMLS CUI [4,2])
Excision of axillary lymph nodes | Sentinel Lymph Node Positive | Status pre- Neoadjuvant Therapy
Item
axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy.
boolean
C0193867 (UMLS CUI [1])
C1522495 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Colon Carcinoma In situ Treated | Exception Carcinoma in situ of skin Treated | Exception Disease Free Duration
Item
history of concurrent or previous non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. a patient with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0699790 (UMLS CUI [6,2])
C0444498 (UMLS CUI [6,3])
C1522326 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0154073 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
C0332296 (UMLS CUI [8,3])
C0449238 (UMLS CUI [8,4])
Investigational New Drugs
Item
treatment with any investigational drug within 28 days prior to randomization
boolean
C0013230 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
current national cancer institute common terminology criteria for adverse events (nci ctcae) v4.03 grade >/= 2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Medical condition At risk Patient safety | Medical condition compromises Completion of clinical trial | Surgery At risk Patient safety | Surgery compromises Completion of clinical trial | Findings At risk Patient safety | Findings compromise Completion of clinical trial
Item
any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0038895 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0038895 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
C2607943 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C2607943 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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