ID

38121

Description

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

Lien

https://clinicaltrials.gov/show/NCT01791985

Mots-clés

Versions (1)
  1. 19/09/2019 19/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 septembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Breast Cancer NCT01791985

Anglais

Eligibility Breast Cancer NCT01791985

1 Formulaires  
Criteria
Description

Criteria

written informed consent and ability to comply with study protocol
Description

Informed Consent | Protocol Compliance

Type de données

boolean

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

Age

Type de données

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
Description

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

Type de données

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
Description

ECOG performance status | Life Expectancy Minimum

Type de données

boolean

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

Prior Therapy Breast Carcinoma

Type de données

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
Description

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

Type de données

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*
Description

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

Type de données

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.
Description

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

Type de données

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.
Description

Prior Chemotherapy Advanced disease | Prior Chemotherapy Adjuvant

Type de données

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.
Description

Prior Therapy | exemestane | everolimus | Everolimus Absent

Type de données

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
Description

Prior Therapy | anastrozole | letrozole

Type de données

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.
Description

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

Type de données

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
Description

Hematologic function | Liver function | Renal function

Type de données

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
Description

Tumor Biopsy | Assessment Tumor Biomarkers

Type de données

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
Description

Safety Run-in | Pre treatment | anastrozole | letrozole

Type de données

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.
Description

Duration of treatment Without Restriction | anastrozole | letrozole

Type de données

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
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT01791985

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial