ID

22319

Descripción

Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Disease History Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Palabras clave

Versiones (1)
  1. 29/5/17 29/5/17 -
Subido en

29 de mayo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

Inglés

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

1 formularios  
Disease History Screening
Descripción

Disease History Screening

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1710477
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of first diagnosis of breast cancer
Descripción

Date of first diagnosis of breast cancer

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0678222
Date of first diagnosis of metastatic breast cancer
Descripción

Date of first diagnosis of metastatic breast cancer

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0678222
Histology at first diagnosis, check one:
Descripción

Histology at first diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
Estrogen Receptor Status
Descripción

Estrogen Receptor Status

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1719706
UMLS CUI [1,2]
C1719707
Progesterone Receptor Status
Descripción

Progesterone Receptor Status

Tipo de datos

text

Alias
UMLS CUI [1]
C1514471
Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
Descripción

HER2/neu overexpression status

Tipo de datos

text

Alias
UMLS CUI [1]
C1512413
Stage of disease at first diagnosis, check one:
Descripción

Stage of disease at first diagnosis

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C3172269
UMLS CUI [1,3]
C0678222
Current stage of disease, check one:
Descripción

Current stage of disease

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0678222
Current site of disease, check one:
Descripción

Site of disease

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0678222
For subjects who have had surgery: Is there local recurrence of the original disease?
Descripción

local recurrence of the original disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Abdomen/viscera
Descripción

metastatic disease site Abdomen/viscera

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Adrenals
Descripción

metastatic disease site Adrenals

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001625
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Bone
Descripción

metastatic disease site Bone

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Bone marrow
Descripción

metastatic disease site Bone marrow

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Breast
Descripción

metastatic disease site Breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Chest Wall
Descripción

metastatic disease site Chest Wall

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205076
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: CNS
Descripción

metastatic disease site CNS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Heart
Descripción

metastatic disease site Heart

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Liver
Descripción

metastatic disease site Liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Lung
Descripción

metastatic disease site Lung

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Lymph nodes
Descripción

metastatic disease site Lymph nodes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Pancreas
Descripción

metastatic disease site Pancreas

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030274
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Peritoneum
Descripción

metastatic disease site Peritoneum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031153
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Pleura
Descripción

metastatic disease site Pleura

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032225
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Skin
Descripción

metastatic disease site Skin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Stomach
Descripción

metastatic disease site Stomach

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038351
UMLS CUI [1,2]
C0036525
UMLS CUI [2]
C0678222
Is (are) there any current known metastatic disease site(s) in the: Other, specify
Descripción

metastatic disease site

Tipo de datos

text

Alias
UMLS CUI [1]
C0036525
UMLS CUI [2]
C0678222
Prior Anti-Cancer Surgery Screening
Descripción

Prior Anti-Cancer Surgery Screening

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0920425
Has this subject received surgery for the cancer under study?
Descripción

received surgery for the cancer

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0920425
Date of surgery
Descripción

If YES, record in chronological order below:

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0543467
Procedure
Descripción

Procedure

Tipo de datos

text

Alias
UMLS CUI [1]
C0184661
Prior Anti-Cancer Systemic Therapy Screening
Descripción

Prior Anti-Cancer Systemic Therapy Screening

Alias
UMLS CUI-1
C1515119
UMLS CUI-2
C0920425
Has this subject received prior anti-cancer systemic therapy for the cancer under study?
Descripción

prior anti-cancer systemic therapy for the cancer

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0920425
Regimen no
Descripción

If NO, leave remainder of page blank. If YES, record, in chronological order, all prior therapies for the cancer under study.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0237753
Therapy
Descripción

Therapy

Tipo de datos

text

Alias
UMLS CUI [1]
C1515119
Intent
Descripción

Intent

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C1515119
No. of cycles
Descripción

No. of cycles

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0750480
Total cumulative dose of Anthracycline (mg/m2)
Descripción

Total cumulative dose of Anthracycline

Tipo de datos

float

Unidades de medida
  • mg/m2
Alias
UMLS CUI [1,1]
C0003234
UMLS CUI [1,2]
C3174092
UMLS CUI [2]
C1515119
mg/m2
Date started
Descripción

Date started

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1515119
Date stopped
Descripción

Date stopped

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1515119
Best response
Descripción

Best response

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986560
UMLS CUI [1,2]
C1515119
Date of progression
Descripción

Date of progression

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C1515119
Prior Anti-Cancer Radiotherapy Screening
Descripción

Prior Anti-Cancer Radiotherapy Screening

Alias
UMLS CUI-1
C1522449
UMLS CUI-2
C0920425
Has this subject received prior radiotherapy for the cancer under study?
Descripción

prior radiotherapy for the cancer

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
Site
Descripción

If YES, record in chronological order below.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C1522449
Date started
Descripción

Date started

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1522449
Date stopped
Descripción

Date stopped

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522449
Estimated total dose: amount
Descripción

Estimated total dose amount

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1265611
Estimated total dose: units
Descripción

Estimated total dose units

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1519795
Best response
Descripción

Best response

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986560
UMLS CUI [1,2]
C1522449
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Similar models

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Disease History Screening
C0262926 (UMLS CUI-1)
C1710477 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of first diagnosis of breast cancer
Item
Date of first diagnosis of breast cancer
date
C2316983 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Date of first diagnosis of metastatic breast cancer
Item
Date of first diagnosis of metastatic breast cancer
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Item
Histology at first diagnosis, check one:
text
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Histology at first diagnosis
Code List
Histology at first diagnosis, check one:
CL Item
Infiltrating Duct NOS (IDN)
CL Item
Medullary (M)
CL Item
Lobular Invasive (LI)
CL Item
Mucinous (MU)
CL Item
Tubular (T)
CL Item
Adenocystic (A)
CL Item
Papillary (P)
CL Item
Carcinosarcoma (CA)
CL Item
Other, specify (X)
Item
Estrogen Receptor Status
text
C1719706 (UMLS CUI [1,1])
C1719707 (UMLS CUI [1,2])
Estrogen Receptor Status
Code List
Estrogen Receptor Status
CL Item
ER Positive (EP)
CL Item
ER Negative (EN)
CL Item
ER Status Not Available (EO)
Item
Progesterone Receptor Status
text
C1514471 (UMLS CUI [1])
Progesterone Receptor Status
Code List
Progesterone Receptor Status
CL Item
PR Positive (PP)
CL Item
PR Negative (PN)
CL Item
PR Status Not Available (PO)
Item
Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
text
C1512413 (UMLS CUI [1])
HER2/neu overexpression status
Code List
Archived Tumor Tissue: HER2/neu overexpression status (defined as +3 by IHC or +2 by IHC and FISH+.)
CL Item
Overexpression (OE)
CL Item
Non-overexpression (NE)
Item
Stage of disease at first diagnosis, check one:
integer
C1300072 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Stage of disease at first diagnosis
Code List
Stage of disease at first diagnosis, check one:
CL Item
Stage I (1)
CL Item
Stage II (2)
CL Item
Stage III (3)
CL Item
Stage IV (4)
Item
Current stage of disease, check one:
integer
C1300072 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Current stage of disease
Code List
Current stage of disease, check one:
CL Item
Stage IIIb or Stage IIIc with T4 lesion (1)
CL Item
Stage IV (2)
Item
Current site of disease, check one:
text
C0450429 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Site of disease
Code List
Current site of disease, check one:
CL Item
Visceral (V)
CL Item
Non-Visceral (NV)
local recurrence of the original disease
Item
For subjects who have had surgery: Is there local recurrence of the original disease?
boolean
C0034897 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
metastatic disease site Abdomen/viscera
Item
Is (are) there any current known metastatic disease site(s) in the: Abdomen/viscera
boolean
C0000726 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Adrenals
Item
Is (are) there any current known metastatic disease site(s) in the: Adrenals
boolean
C0001625 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Bone
Item
Is (are) there any current known metastatic disease site(s) in the: Bone
boolean
C0262950 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Bone marrow
Item
Is (are) there any current known metastatic disease site(s) in the: Bone marrow
boolean
C0005953 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Breast
Item
Is (are) there any current known metastatic disease site(s) in the: Breast
boolean
C0006141 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Chest Wall
Item
Is (are) there any current known metastatic disease site(s) in the: Chest Wall
boolean
C0205076 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site CNS
Item
Is (are) there any current known metastatic disease site(s) in the: CNS
boolean
C0686377 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
metastatic disease site Heart
Item
Is (are) there any current known metastatic disease site(s) in the: Heart
boolean
C0018787 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Liver
Item
Is (are) there any current known metastatic disease site(s) in the: Liver
boolean
C0023884 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Lung
Item
Is (are) there any current known metastatic disease site(s) in the: Lung
boolean
C0024109 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Lymph nodes
Item
Is (are) there any current known metastatic disease site(s) in the: Lymph nodes
boolean
C0024204 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Pancreas
Item
Is (are) there any current known metastatic disease site(s) in the: Pancreas
boolean
C0030274 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Peritoneum
Item
Is (are) there any current known metastatic disease site(s) in the: Peritoneum
boolean
C0031153 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Pleura
Item
Is (are) there any current known metastatic disease site(s) in the: Pleura
boolean
C0032225 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Skin
Item
Is (are) there any current known metastatic disease site(s) in the: Skin
boolean
C1123023 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site Stomach
Item
Is (are) there any current known metastatic disease site(s) in the: Stomach
boolean
C0038351 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
metastatic disease site
Item
Is (are) there any current known metastatic disease site(s) in the: Other, specify
text
C0036525 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Item Group
Prior Anti-Cancer Surgery Screening
C0543467 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
Item
Has this subject received surgery for the cancer under study?
text
C0543467 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
received surgery for the cancer
Code List
Has this subject received surgery for the cancer under study?
CL Item
Yes (Y)
CL Item
No (N)
Date of surgery
Item
Date of surgery
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Procedure
Item
Procedure
text
C0184661 (UMLS CUI [1])
Item Group
Prior Anti-Cancer Systemic Therapy Screening
C1515119 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
Item
Has this subject received prior anti-cancer systemic therapy for the cancer under study?
text
C1515119 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
received surgery for the cancer
Code List
Has this subject received prior anti-cancer systemic therapy for the cancer under study?
CL Item
Yes (Y)
CL Item
No (N)
Regimen no
Item
Regimen no
text
C0040808 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Therapy
Item
Therapy
text
C1515119 (UMLS CUI [1])
Item
Intent
text
C1283828 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Intent
Code List
Intent
CL Item
Neo-adjuvant (N )
CL Item
Adjuvant (A )
CL Item
Advanced or metastatic  (M )
CL Item
Not applicable (NA )
No. of cycles
Item
No. of cycles
text
C1515119 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Total cumulative dose of Anthracycline
Item
Total cumulative dose of Anthracycline (mg/m2)
float
C0003234 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Item
Best response
text
C2986560 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Best response
Code List
Best response
CL Item
Complete response (CR )
CL Item
Partial response (PR )
CL Item
Stable disease (SD )
CL Item
Progressive disease (PD )
CL Item
Unknown (UNK )
CL Item
Not applicable (e.g., adjuvant therapy) (NA )
Date of progression
Item
Date of progression
date
C0011008 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Item Group
Prior Anti-Cancer Radiotherapy Screening
C1522449 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
Item
Has this subject received prior radiotherapy for the cancer under study?
text
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
received surgery for the cancer
Code List
Has this subject received prior radiotherapy for the cancer under study?
CL Item
Yes (Y)
CL Item
No (N)
Site
Item
Site
text
C1515974 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Date started
Item
Date started
date
C0808070 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Date stopped
Item
Date stopped
date
C0806020 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Estimated total dose amount
Item
Estimated total dose: amount
float
C1522449 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Estimated total dose units
Item
Estimated total dose: units
text
C1522449 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Item
Best response
text
C2986560 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Best response
Code List
Best response
CL Item
Complete response (CR )
CL Item
Partial response (PR )
CL Item
Stable disease (SD )
CL Item
Progressive disease (PD )
CL Item
Unknown (UNK )
CL Item
Not applicable (e.g., adjuvant therapy) (NA )
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