ID

20423

Description

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

Keywords

Versions (1)
  1. 2/22/17 2/22/17 -
Uploaded on

February 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00897702

English

Eligibility Breast Cancer NCT00897702

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients:
Description

ID.1

Data type

boolean

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

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

Data type

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
Description

ID.3

Data type

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.
Description

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

Data type

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).
Description

disease progression or recurrence after prior therapy

Data type

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+.
Description

biopsy of breast showed her2 positive carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C4031572
cohort 2
Description

ID.7

Data type

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.
Description

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

Data type

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
Description

ID.9

Data type

boolean

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

received therapy for breast cancer

Data type

boolean

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

Exclusion Criteria

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

informed consent, biopsy

Data type

boolean

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

Repeat; Biopsy; Medical contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C1301624
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Similar models

Eligibility Breast Cancer NCT00897702

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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