ID

38068

Description

A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With LCL161 in Patients With Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01617668

Link

https://clinicaltrials.gov/show/NCT01617668

Keywords

Versions (1)
  1. 9/15/19 9/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01617668

English

Eligibility Breast Cancer NCT01617668

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of invasive triple negative breast cancer
Description

Triple Negative Breast Neoplasm Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C0205281
known status for the lcl161 predictive gene expression signature as determined during molecular pre-screening
Description

LCL161 | Gene Expression Signature predictive

Data type

boolean

Alias
UMLS CUI [1]
C2984020
UMLS CUI [2,1]
C0017262
UMLS CUI [2,2]
C1708225
UMLS CUI [2,3]
C0681890
candidates for mastectomy or breast-conserving surgery
Description

Patients Appropriate Mastectomy | Patients Appropriate Breast-Conserving Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0024881
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0917927
primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous amendment #3 was tumor size greater than 10 mm)
Description

Primary tumor Diameter Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0011923
regional nodes n0-n2
Description

Regional lymph nodes TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1179441
UMLS CUI [1,2]
C3258246
absence of distant metastatic disease
Description

Distant metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function
Description

Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
adequate liver function and serum transaminases
Description

Liver function | Transaminase Assay

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0919834
adequate renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral or inflammatory breast cancer (bilateral mammography is required during screening/baseline); locally recurrent breast cancer
Description

Bilateral breast cancer | Inflammatory Breast Carcinoma | Bilateral mammography Required | Breast cancer recurrent Locally

Data type

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0278601
UMLS CUI [3,1]
C0203027
UMLS CUI [3,2]
C1514873
UMLS CUI [4,1]
C0278493
UMLS CUI [4,2]
C1517927
patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months
Description

Systemic therapy Cancer Other | Systemic therapy Recent Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C0006826
uncontrolled cardiac disease
Description

Heart Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
Description

Adrenal Cortex Hormones Dose per day chronic | Prednisone Dose | Glucocorticoids Equivalent | Inhaled steroids allowed | Topical steroids allowed | Therapeutic immunosuppression chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439505
UMLS CUI [1,4]
C0205191
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C2065041
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C2064827
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0021079
UMLS CUI [6,2]
C0205191
impaired gi function that may affect the absorption of lcl161
Description

Abnormal digestive tract function Affecting Absorption LCL161

Data type

boolean

Alias
UMLS CUI [1,1]
C0232459
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C2984020
pregnant or breast feeding (lactating) women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment
Description

Childbearing Potential | Exception Use of Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT01617668

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Triple Negative Breast Neoplasm Invasive
Item
histologically confirmed diagnosis of invasive triple negative breast cancer
boolean
C3539878 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
LCL161 | Gene Expression Signature predictive
Item
known status for the lcl161 predictive gene expression signature as determined during molecular pre-screening
boolean
C2984020 (UMLS CUI [1])
C0017262 (UMLS CUI [2,1])
C1708225 (UMLS CUI [2,2])
C0681890 (UMLS CUI [2,3])
Patients Appropriate Mastectomy | Patients Appropriate Breast-Conserving Surgery
Item
candidates for mastectomy or breast-conserving surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0024881 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0917927 (UMLS CUI [2,3])
Primary tumor Diameter Imaging
Item
primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous amendment #3 was tumor size greater than 10 mm)
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Regional lymph nodes TNM clinical staging
Item
regional nodes n0-n2
boolean
C1179441 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Distant metastasis Absent
Item
absence of distant metastatic disease
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function
Item
adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Liver function | Transaminase Assay
Item
adequate liver function and serum transaminases
boolean
C0232741 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bilateral breast cancer | Inflammatory Breast Carcinoma | Bilateral mammography Required | Breast cancer recurrent Locally
Item
bilateral or inflammatory breast cancer (bilateral mammography is required during screening/baseline); locally recurrent breast cancer
boolean
C0281267 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C0203027 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0278493 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
Systemic therapy Cancer Other | Systemic therapy Recent Malignant Neoplasm
Item
patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months
boolean
C1515119 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Heart Disease Uncontrolled
Item
uncontrolled cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Adrenal Cortex Hormones Dose per day chronic | Prednisone Dose | Glucocorticoids Equivalent | Inhaled steroids allowed | Topical steroids allowed | Therapeutic immunosuppression chronic
Item
patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0021079 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
Abnormal digestive tract function Affecting Absorption LCL161
Item
impaired gi function that may affect the absorption of lcl161
boolean
C0232459 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C2984020 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Use of Contraceptive methods
Item
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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