ID

34915

Description

Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT02010021

Link

https://clinicaltrials.gov/show/NCT02010021

Keywords

Versions (1)
  1. 2/4/19 2/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02010021

English

Eligibility Breast Cancer NCT02010021

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic documentation of invasive breast cancer by core needle or incisional biopsy. excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.
Description

Invasive carcinoma of breast Core needle biopsy | Invasive carcinoma of breast Incisional biopsy | Tumor tissue sample Micron Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0184922
UMLS CUI [3,1]
C0475358
UMLS CUI [3,2]
C0439201
UMLS CUI [3,3]
C0700320
the invasive cancer must be estrogen receptor alpha (er)-positive, with er staining present in greater than 50% staining of invasive cancer cells by ihc.
Description

Invasive carcinoma of breast Estrogen Receptor alpha Positive | Estrogen Receptor Staining Method | Invasive carcinoma of breast Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0665341
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C4055053
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0021044
the invasive cancer must be her2 (human epidermal growth factor receptor 2) negative (ihc 0-1+, or with a fish ratio of <1.8 if ihc is 2+ or if ihc has not been done).
Description

Invasive carcinoma of breast HER2 Negative Immunohistochemistry | Invasive carcinoma of breast HER2 Negative FISH

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C0162789
clinical stage i-iii invasive breast cancer with the intent to treat with surgical resection of the primary tumor. tumor must be ≥ 2cm to provide adequate tissue.
Description

Invasive carcinoma of breast TNM Breast tumor staging | Intent Excision Primary tumor | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1283828
UMLS CUI [2,2]
C0728940
UMLS CUI [2,3]
C0677930
UMLS CUI [3]
C0475440
patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. samples from all available tumors are requested for research purposes.
Description

Disease Multicentric | Bilateral Disease | Target Lesion Eligibility criteria Fulfill | Tumor tissue sample Requested Research

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439743
UMLS CUI [2]
C1511113
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C1512693
UMLS CUI [3,3]
C1550543
UMLS CUI [4,1]
C0475358
UMLS CUI [4,2]
C1272683
UMLS CUI [4,3]
C0035168
women ≥ age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.
Description

Gender | Age | Indication Aromatase Inhibitors Adjuvant therapy | Postmenopausal state | Premenopausal state Associated with Ovariectomy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0593802
UMLS CUI [3,3]
C0677850
UMLS CUI [4]
C0232970
UMLS CUI [5,1]
C0232969
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0029936
patients must meet the following clinical laboratory criteria:
Description

Laboratory Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
absolute neutrophil count (anc)≥ 1000/mm3 and platelet count ≥ 75,000/mm3. total bilirubin
Description

Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
≤ 1.5 x the upper limit of normal range (uln). alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 x uln.
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
ability to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior endocrine therapy for any histologically confirmed cancer is not allowed. prior endocrine therapy that was administered ≥ 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.
Description

Hormone Therapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0006826
systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.
Description

Pharmacotherapy Systemic Inducing Ovarian suppression | Relationship Premenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205263
UMLS CUI [1,4]
C0677922
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0232969
any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides letrozole (10-21)days before surgical resection of the primary tumor).
Description

Neoadjuvant Therapy Breast Carcinoma | Antineoplastic Agents | Exception Letrozole

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0003392
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0246421
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Similar models

Eligibility Breast Cancer NCT02010021

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Core needle biopsy | Invasive carcinoma of breast Incisional biopsy | Tumor tissue sample Micron Section
Item
histologic documentation of invasive breast cancer by core needle or incisional biopsy. excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0184922 (UMLS CUI [2,2])
C0475358 (UMLS CUI [3,1])
C0439201 (UMLS CUI [3,2])
C0700320 (UMLS CUI [3,3])
Invasive carcinoma of breast Estrogen Receptor alpha Positive | Estrogen Receptor Staining Method | Invasive carcinoma of breast Immunohistochemistry
Item
the invasive cancer must be estrogen receptor alpha (er)-positive, with er staining present in greater than 50% staining of invasive cancer cells by ihc.
boolean
C0853879 (UMLS CUI [1,1])
C0665341 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C4055053 (UMLS CUI [2])
C0853879 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
Invasive carcinoma of breast HER2 Negative Immunohistochemistry | Invasive carcinoma of breast HER2 Negative FISH
Item
the invasive cancer must be her2 (human epidermal growth factor receptor 2) negative (ihc 0-1+, or with a fish ratio of <1.8 if ihc is 2+ or if ihc has not been done).
boolean
C0853879 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
Invasive carcinoma of breast TNM Breast tumor staging | Intent Excision Primary tumor | Tumor size
Item
clinical stage i-iii invasive breast cancer with the intent to treat with surgical resection of the primary tumor. tumor must be ≥ 2cm to provide adequate tissue.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1283828 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C0677930 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3])
Disease Multicentric | Bilateral Disease | Target Lesion Eligibility criteria Fulfill | Tumor tissue sample Requested Research
Item
patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. samples from all available tumors are requested for research purposes.
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C1511113 (UMLS CUI [2])
C2986546 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
C0475358 (UMLS CUI [4,1])
C1272683 (UMLS CUI [4,2])
C0035168 (UMLS CUI [4,3])
Gender | Age | Indication Aromatase Inhibitors Adjuvant therapy | Postmenopausal state | Premenopausal state Associated with Ovariectomy
Item
women ≥ age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0593802 (UMLS CUI [3,2])
C0677850 (UMLS CUI [3,3])
C0232970 (UMLS CUI [4])
C0232969 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0029936 (UMLS CUI [5,3])
Laboratory Criteria Fulfill
Item
patients must meet the following clinical laboratory criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement
Item
absolute neutrophil count (anc)≥ 1000/mm3 and platelet count ≥ 75,000/mm3. total bilirubin
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
≤ 1.5 x the upper limit of normal range (uln). alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 x uln.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Informed Consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Malignant Neoplasms
Item
prior endocrine therapy for any histologically confirmed cancer is not allowed. prior endocrine therapy that was administered ≥ 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.
boolean
C0279025 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Pharmacotherapy Systemic Inducing Ovarian suppression | Relationship Premenopausal state
Item
systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.
boolean
C0013216 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
C0677922 (UMLS CUI [1,4])
C0439849 (UMLS CUI [2,1])
C0232969 (UMLS CUI [2,2])
Neoadjuvant Therapy Breast Carcinoma | Antineoplastic Agents | Exception Letrozole
Item
any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides letrozole (10-21)days before surgical resection of the primary tumor).
boolean
C0600558 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0246421 (UMLS CUI [3,2])
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