ID

38121

Beskrivning

AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL); ODM derived from: https://clinicaltrials.gov/show/NCT01791985

Länk

https://clinicaltrials.gov/show/NCT01791985

Nyckelord

Versioner (1)
  1. 2019-09-19 2019-09-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01791985

Engelsk

Eligibility Breast Cancer NCT01791985

1 Formulär  
Criteria
Beskrivning

Criteria

written informed consent and ability to comply with study protocol
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
aged ≥ 25 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
post menopausal women with histological confirmation of breast cancer with documented positive oestrogen receptor status (er+) of primary or metastatic tumour tissue
Beskrivning

Postmenopausal state | Breast Carcinoma | Tissue sample Primary tumor Estrogen receptor positive | Tissue sample Neoplasm Metastasis Estrogen receptor positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C0475358
UMLS CUI [3,2]
C0677930
UMLS CUI [3,3]
C0279754
UMLS CUI [4,1]
C0475358
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C0279754
ecog performance status 0-1 and minimum life expectancy of 12 weeks
Beskrivning

ECOG performance status | Life Expectancy Minimum

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C1524031
fulfils criteria for previous treatment of breast cancer:
Beskrivning

Prior Therapy Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
safety run-in: relapse during a single regimen of adjuvant endocrine therapy with either anastrozole or letrozole or
Beskrivning

Safety Run-in | Relapse | Hormone Therapy Adjuvant | anastrozole | letrozole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C3274438
UMLS CUI [2]
C0035020
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C1522673
UMLS CUI [4]
C0290883
UMLS CUI [5]
C0246421
progression during first line endocrine therapy with anastrozole or letrozole for advanced breast cancer phase iia: progressing or progression at some point during breast cancer treatment on endocrine therapy with a non-steroidal ai*
Beskrivning

Disease Progression | First line Hormone Therapy Advanced breast cancer | anastrozole | letrozole | Breast Cancer Therapeutic Procedure | Hormone Therapy | Non-Steroidal Aromatase Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C3495917
UMLS CUI [3]
C0290883
UMLS CUI [4]
C0246421
UMLS CUI [5]
C1511300
UMLS CUI [6]
C0279025
UMLS CUI [7]
C1518386
co-administration of a targeted agent with the non-steroidal ai is permitted providing all toxicities have recovered to ctcae grade 1 or below.
Beskrivning

Targeted Therapy Non-Steroidal Aromatase Inhibitor | Toxicity Recovery CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C1518386
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C1516728
prior chemotherapy in the advanced and adjuvant setting is permitted.
Beskrivning

Prior Chemotherapy Advanced disease | Prior Chemotherapy Adjuvant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0679246
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1522673
prior treatment with exemestane with or without everolimus is permitted.
Beskrivning

Prior Therapy | exemestane | everolimus | Everolimus Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0851344
UMLS CUI [3]
C0541315
UMLS CUI [4,1]
C0541315
UMLS CUI [4,2]
C0332197
*anastrozole or letrozole does not have to be the most recent therapy
Beskrivning

Prior Therapy | anastrozole | letrozole

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0290883
UMLS CUI [3]
C0246421
safety run-in: at least 1 lesion (measurable/non measurable) that can be accurately assessed by ct/mri/plain x-ray at baseline and follow-up phase iia: at least 1 measurable lesion ≥ 10mm in longest diameter (or ≥ 15mm in the short axis for nodal disease) at baseline that can be accurately assessed by ct/mri at baseline and follow up. patients with bone only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by ct or mri.
Beskrivning

Safety Run-in | Measurable lesion Quantity CT | Non-Measurable Lesion Quantity CT | Measurable lesion Quantity MRI | Non-Measurable Lesion Quantity MRI | Measurable lesion Quantity Plain x-ray | Non-Measurable Lesion Quantity Plain x-ray | Follow-up | Measurable lesion Quantity Longest Diameter | Measurable lesion Short axis Disorder of lymph node | Secondary malignant neoplasm of bone | Lytic lesion CT | Lytic lesion MRI | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C3274438
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C1334988
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C1334988
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0024485
UMLS CUI [6,1]
C1513041
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C1306645
UMLS CUI [7,1]
C1334988
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C1306645
UMLS CUI [8]
C3274571
UMLS CUI [9,1]
C1513041
UMLS CUI [9,2]
C1265611
UMLS CUI [9,3]
C0552406
UMLS CUI [10,1]
C1513041
UMLS CUI [10,2]
C0522488
UMLS CUI [10,3]
C0272394
UMLS CUI [11]
C0153690
UMLS CUI [12,1]
C0221204
UMLS CUI [12,2]
C0040405
UMLS CUI [13,1]
C0221204
UMLS CUI [13,2]
C0024485
UMLS CUI [14]
C3846158
adequate haematological, hepatic and renal function
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
phase iia: mandatory provision of tumour biopsy for assessment of oncology biomarkers
Beskrivning

Tumor Biopsy | Assessment Tumor Biomarkers

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0041366
safety run-in: study entry must be preceded by a minimum of 21 days of anastrozole or letrozole treatment
Beskrivning

Safety Run-in | Pre treatment | anastrozole | letrozole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C3274438
UMLS CUI [2]
C2709094
UMLS CUI [3]
C0290883
UMLS CUI [4]
C0246421
phase iia: no restriction to duration of anastrozole or letrozole treatment prior to study entry.
Beskrivning

Duration of treatment Without Restriction | anastrozole | letrozole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0443288
UMLS CUI [2]
C0290883
UMLS CUI [3]
C0246421
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Similar models

Eligibility Breast Cancer NCT01791985

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Informed Consent | Protocol Compliance
Item
written informed consent and ability to comply with study protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Age
Item
aged ≥ 25 years of age
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Breast Carcinoma | Tissue sample Primary tumor Estrogen receptor positive | Tissue sample Neoplasm Metastasis Estrogen receptor positive
Item
post menopausal women with histological confirmation of breast cancer with documented positive oestrogen receptor status (er+) of primary or metastatic tumour tissue
boolean
C0232970 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0475358 (UMLS CUI [3,1])
C0677930 (UMLS CUI [3,2])
C0279754 (UMLS CUI [3,3])
C0475358 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0279754 (UMLS CUI [4,3])
ECOG performance status | Life Expectancy Minimum
Item
ecog performance status 0-1 and minimum life expectancy of 12 weeks
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Prior Therapy Breast Carcinoma
Item
fulfils criteria for previous treatment of breast cancer:
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Safety Run-in | Relapse | Hormone Therapy Adjuvant | anastrozole | letrozole
Item
safety run-in: relapse during a single regimen of adjuvant endocrine therapy with either anastrozole or letrozole or
boolean
C0036043 (UMLS CUI [1,1])
C3274438 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C0290883 (UMLS CUI [4])
C0246421 (UMLS CUI [5])
Disease Progression | First line Hormone Therapy Advanced breast cancer | anastrozole | letrozole | Breast Cancer Therapeutic Procedure | Hormone Therapy | Non-Steroidal Aromatase Inhibitor
Item
progression during first line endocrine therapy with anastrozole or letrozole for advanced breast cancer phase iia: progressing or progression at some point during breast cancer treatment on endocrine therapy with a non-steroidal ai*
boolean
C0242656 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C3495917 (UMLS CUI [2,3])
C0290883 (UMLS CUI [3])
C0246421 (UMLS CUI [4])
C1511300 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C1518386 (UMLS CUI [7])
Targeted Therapy Non-Steroidal Aromatase Inhibitor | Toxicity Recovery CTCAE Grades
Item
co-administration of a targeted agent with the non-steroidal ai is permitted providing all toxicities have recovered to ctcae grade 1 or below.
boolean
C2985566 (UMLS CUI [1,1])
C1518386 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Prior Chemotherapy Advanced disease | Prior Chemotherapy Adjuvant
Item
prior chemotherapy in the advanced and adjuvant setting is permitted.
boolean
C1514457 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
Prior Therapy | exemestane | everolimus | Everolimus Absent
Item
prior treatment with exemestane with or without everolimus is permitted.
boolean
C1514463 (UMLS CUI [1])
C0851344 (UMLS CUI [2])
C0541315 (UMLS CUI [3])
C0541315 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Prior Therapy | anastrozole | letrozole
Item
*anastrozole or letrozole does not have to be the most recent therapy
boolean
C1514463 (UMLS CUI [1])
C0290883 (UMLS CUI [2])
C0246421 (UMLS CUI [3])
Safety Run-in | Measurable lesion Quantity CT | Non-Measurable Lesion Quantity CT | Measurable lesion Quantity MRI | Non-Measurable Lesion Quantity MRI | Measurable lesion Quantity Plain x-ray | Non-Measurable Lesion Quantity Plain x-ray | Follow-up | Measurable lesion Quantity Longest Diameter | Measurable lesion Short axis Disorder of lymph node | Secondary malignant neoplasm of bone | Lytic lesion CT | Lytic lesion MRI | Other Coding
Item
safety run-in: at least 1 lesion (measurable/non measurable) that can be accurately assessed by ct/mri/plain x-ray at baseline and follow-up phase iia: at least 1 measurable lesion ≥ 10mm in longest diameter (or ≥ 15mm in the short axis for nodal disease) at baseline that can be accurately assessed by ct/mri at baseline and follow up. patients with bone only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by ct or mri.
boolean
C0036043 (UMLS CUI [1,1])
C3274438 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C1334988 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C1334988 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C1513041 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C1306645 (UMLS CUI [6,3])
C1334988 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C1306645 (UMLS CUI [7,3])
C3274571 (UMLS CUI [8])
C1513041 (UMLS CUI [9,1])
C1265611 (UMLS CUI [9,2])
C0552406 (UMLS CUI [9,3])
C1513041 (UMLS CUI [10,1])
C0522488 (UMLS CUI [10,2])
C0272394 (UMLS CUI [10,3])
C0153690 (UMLS CUI [11])
C0221204 (UMLS CUI [12,1])
C0040405 (UMLS CUI [12,2])
C0221204 (UMLS CUI [13,1])
C0024485 (UMLS CUI [13,2])
C3846158 (UMLS CUI [14])
Hematologic function | Liver function | Renal function
Item
adequate haematological, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Tumor Biopsy | Assessment Tumor Biomarkers
Item
phase iia: mandatory provision of tumour biopsy for assessment of oncology biomarkers
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C0041366 (UMLS CUI [2,2])
Safety Run-in | Pre treatment | anastrozole | letrozole
Item
safety run-in: study entry must be preceded by a minimum of 21 days of anastrozole or letrozole treatment
boolean
C0036043 (UMLS CUI [1,1])
C3274438 (UMLS CUI [1,2])
C2709094 (UMLS CUI [2])
C0290883 (UMLS CUI [3])
C0246421 (UMLS CUI [4])
Duration of treatment Without Restriction | anastrozole | letrozole
Item
phase iia: no restriction to duration of anastrozole or letrozole treatment prior to study entry.
boolean
C0444921 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
C0290883 (UMLS CUI [2])
C0246421 (UMLS CUI [3])
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