ID

38157

Description

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01872260

Link

https://clinicaltrials.gov/show/NCT01872260

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01872260

English

Eligibility Breast Cancer NCT01872260

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal, estrogen-receptor positive breast cancer
Description

Postmenopausal state | Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C2938924
phase ib dose escalation only: any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
Description

Dose Escalation | Hormone Therapy Quantity | Cytotoxic Chemotherapy Neoplasm Metastasis Advanced | Cytotoxic Chemotherapy Locally Advanced Disease Setting

Data type

boolean

Alias
UMLS CUI [1]
C3816728
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0677881
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0205179
UMLS CUI [4,1]
C0677881
UMLS CUI [4,2]
C4086552
phase ib dose expansions: no prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
Description

Dose Expansion | Systemic therapy Absent | Neoplasm Metastasis Advanced | Locally Advanced Disease Setting | Exception Letrozole

Data type

boolean

Alias
UMLS CUI [1]
C4521283
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0205179
UMLS CUI [4]
C4086552
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0246421
phase ii: no prior systemic treatment in the advanced (metastatic or locally advanced) setting.
Description

Systemic therapy Absent | Neoplasm Metastasis Advanced | Locally Advanced Disease Setting

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C4086552
phase ib dose expansions and phase ii: patients who received (neo)adjuvant therapy for breast cancer are eligible. prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease free interval is greater than 12 months from the completion of treatment.
Description

Dose Expansion | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | letrozole | anastrozole | Interval Disease Free

Data type

boolean

Alias
UMLS CUI [1]
C4521283
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C0678222
UMLS CUI [4]
C0246421
UMLS CUI [5]
C0290883
UMLS CUI [6,1]
C1272706
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2-overexpression in the patient's tumor tissue
Description

Tumor tissue sample HER2 Protein Overexpression

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1515560
patients with active cns or other brain metastases
Description

CNS metastases | Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
major surgery within 2 weeks
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
acute or chronic pancreatitis
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
bilateral diffuse lymphangitic carcinomatosis
Description

Lymphangitis carcinomatosa Diffuse Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0238258
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0238767
another malignancy within 3 years
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
receiving hormone replacement therapy that cannot be discontinued
Description

Hormone replacement therapy Discontinuation Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1272705
impaired cardiac function
Description

Decreased cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232166
patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dl / 7.0 mmol/l or hemoglobin a1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
Description

Diabetes Mellitus Treated | Sign or Symptom Diabetes Mellitus | Glucose measurement, fasting | Hemoglobin A1c measurement | Gestational Diabetes | Steroid-induced diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0011849
UMLS CUI [3]
C0202045
UMLS CUI [4]
C0474680
UMLS CUI [5]
C0085207
UMLS CUI [6]
C0342269
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial 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 NCT01872260

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Oestrogen receptor positive breast cancer
Item
postmenopausal, estrogen-receptor positive breast cancer
boolean
C0232970 (UMLS CUI [1])
C2938924 (UMLS CUI [2])
Dose Escalation | Hormone Therapy Quantity | Cytotoxic Chemotherapy Neoplasm Metastasis Advanced | Cytotoxic Chemotherapy Locally Advanced Disease Setting
Item
phase ib dose escalation only: any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
boolean
C3816728 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0677881 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C0677881 (UMLS CUI [4,1])
C4086552 (UMLS CUI [4,2])
Dose Expansion | Systemic therapy Absent | Neoplasm Metastasis Advanced | Locally Advanced Disease Setting | Exception Letrozole
Item
phase ib dose expansions: no prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
boolean
C4521283 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C4086552 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0246421 (UMLS CUI [5,2])
Systemic therapy Absent | Neoplasm Metastasis Advanced | Locally Advanced Disease Setting
Item
phase ii: no prior systemic treatment in the advanced (metastatic or locally advanced) setting.
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C4086552 (UMLS CUI [3])
Dose Expansion | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | letrozole | anastrozole | Interval Disease Free
Item
phase ib dose expansions and phase ii: patients who received (neo)adjuvant therapy for breast cancer are eligible. prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease free interval is greater than 12 months from the completion of treatment.
boolean
C4521283 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0246421 (UMLS CUI [4])
C0290883 (UMLS CUI [5])
C1272706 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Tumor tissue sample HER2 Protein Overexpression
Item
her2-overexpression in the patient's tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
CNS metastases | Metastatic malignant neoplasm to brain
Item
patients with active cns or other brain metastases
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Major surgery
Item
major surgery within 2 weeks
boolean
C0679637 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Lymphangitis carcinomatosa Diffuse Bilateral
Item
bilateral diffuse lymphangitic carcinomatosis
boolean
C0238258 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
Cancer Other
Item
another malignancy within 3 years
boolean
C1707251 (UMLS CUI [1])
Hormone replacement therapy Discontinuation Unsuccessful
Item
receiving hormone replacement therapy that cannot be discontinued
boolean
C0282402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Decreased cardiac function
Item
impaired cardiac function
boolean
C0232166 (UMLS CUI [1])
Diabetes Mellitus Treated | Sign or Symptom Diabetes Mellitus | Glucose measurement, fasting | Hemoglobin A1c measurement | Gestational Diabetes | Steroid-induced diabetes
Item
patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dl / 7.0 mmol/l or hemoglobin a1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
boolean
C0011849 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0202045 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
C0085207 (UMLS CUI [5])
C0342269 (UMLS CUI [6])
Clinical Trial 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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