ID

20422

Beschreibung

Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00897702

Link

https://clinicaltrials.gov/show/NCT00897702

Stichworte

Versionen (1)
  1. 22.02.17 22.02.17 -
Hochgeladen am

22. Februar 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00897702

Englisch

Eligibility Breast Cancer NCT00897702

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients:
Beschreibung

ID.1

Datentyp

boolean

diagnosed with progressive, recurrent or metastatic her2+ or er+ breast cancer.
Beschreibung

HER2-positive carcinoma of breast; Estrogen receptor positive; Recurrent disease; Progressive Disease; Metastatic Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0277556
UMLS CUI [1,4]
C1335499
UMLS CUI [1,5]
C2939420
cohort 1
Beschreibung

ID.3

Datentyp

boolean

patients who previously received treatment with anti-her2 therapy (including trastuzumab, pertuzumab, tdm1, or lapatinib) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-her2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
Beschreibung

Prior Chemotherapy; Adjuvant therapy; trastuzumab; pertuzumab; lapatinib; ado-trastuzumab emtansine | Progressive Disease; Recurrent disease; Metastatic Neoplasm; Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0677850
UMLS CUI [1,3]
C0728747
UMLS CUI [1,4]
C1328025
UMLS CUI [1,5]
C1506770
UMLS CUI [1,6]
C2935436
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C2939420
UMLS CUI [2,4]
C0678222
evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by recist criteria or new metastasis).
Beschreibung

disease progression or recurrence after prior therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0679254
UMLS CUI [3]
C1514463
prior tumor biopsy (may be original) defined as her2+ by amplification by fish (>1.9 gene copy number) or ihc 3+.
Beschreibung

biopsy of breast showed her2 positive carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C4031572
cohort 2
Beschreibung

ID.7

Datentyp

boolean

patients who previously received treatment with hormonal therapy (including tamoxifen, toremifene, raloxifene, anastrozole, letrozole, exemestane, fulvestrant, arn-810) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
Beschreibung

Prior Hormone Therapy; Adjuvant therapy | Tamoxifen; Toremifene; Raloxifene; anastrozole; letrozole; exemestane; fulvestrant; Selective Estrogen Receptor Degrader ARN-810 | Progressive Disease; Recurrent disease; Metastatic Neoplasm; Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C0076836
UMLS CUI [2,3]
C0244404
UMLS CUI [2,4]
C0290883
UMLS CUI [2,5]
C0246421
UMLS CUI [2,6]
C0851344
UMLS CUI [2,7]
C0935916
UMLS CUI [2,8]
C3827161
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C0277556
UMLS CUI [3,3]
C2939420
UMLS CUI [3,4]
C0678222
cohort 3
Beschreibung

ID.9

Datentyp

boolean

patients not eligible for cohorts 1 or 2, but previously received treatment of any other kind for breast cancer.
Beschreibung

received therapy for breast cancer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332154
UMLS CUI [1,2]
C0678222
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are unable to consent to a biopsy.
Beschreibung

informed consent, biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0677862
patients for whom a repeat biopsy would be medically unsafe
Beschreibung

Repeat; Biopsy; Medical contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C1301624
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Ähnliche Modelle

Eligibility Breast Cancer NCT00897702

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
all patients:
boolean
HER2-positive carcinoma of breast; Estrogen receptor positive; Recurrent disease; Progressive Disease; Metastatic Neoplasm
Item
diagnosed with progressive, recurrent or metastatic her2+ or er+ breast cancer.
boolean
C1960398 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1335499 (UMLS CUI [1,4])
C2939420 (UMLS CUI [1,5])
ID.3
Item
cohort 1
boolean
Prior Chemotherapy; Adjuvant therapy; trastuzumab; pertuzumab; lapatinib; ado-trastuzumab emtansine | Progressive Disease; Recurrent disease; Metastatic Neoplasm; Breast Carcinoma
Item
patients who previously received treatment with anti-her2 therapy (including trastuzumab, pertuzumab, tdm1, or lapatinib) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-her2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
boolean
C1514457 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
C1328025 (UMLS CUI [1,4])
C1506770 (UMLS CUI [1,5])
C2935436 (UMLS CUI [1,6])
C1335499 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C2939420 (UMLS CUI [2,3])
C0678222 (UMLS CUI [2,4])
disease progression or recurrence after prior therapy
Item
evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by recist criteria or new metastasis).
boolean
C0242656 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
biopsy of breast showed her2 positive carcinoma
Item
prior tumor biopsy (may be original) defined as her2+ by amplification by fish (>1.9 gene copy number) or ihc 3+.
boolean
C4031572 (UMLS CUI [1])
ID.7
Item
cohort 2
boolean
Prior Hormone Therapy; Adjuvant therapy | Tamoxifen; Toremifene; Raloxifene; anastrozole; letrozole; exemestane; fulvestrant; Selective Estrogen Receptor Degrader ARN-810 | Progressive Disease; Recurrent disease; Metastatic Neoplasm; Breast Carcinoma
Item
patients who previously received treatment with hormonal therapy (including tamoxifen, toremifene, raloxifene, anastrozole, letrozole, exemestane, fulvestrant, arn-810) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
boolean
C1514460 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2,1])
C0076836 (UMLS CUI [2,2])
C0244404 (UMLS CUI [2,3])
C0290883 (UMLS CUI [2,4])
C0246421 (UMLS CUI [2,5])
C0851344 (UMLS CUI [2,6])
C0935916 (UMLS CUI [2,7])
C3827161 (UMLS CUI [2,8])
C1335499 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C2939420 (UMLS CUI [3,3])
C0678222 (UMLS CUI [3,4])
ID.9
Item
cohort 3
boolean
received therapy for breast cancer
Item
patients not eligible for cohorts 1 or 2, but previously received treatment of any other kind for breast cancer.
boolean
C0332154 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
informed consent, biopsy
Item
patients who are unable to consent to a biopsy.
boolean
C0021430 (UMLS CUI [1,1])
C0677862 (UMLS CUI [1,2])
Repeat; Biopsy; Medical contraindication
Item
patients for whom a repeat biopsy would be medically unsafe
boolean
C0205341 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
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