ID

18860

Description

Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00237198

Link

https://clinicaltrials.gov/show/NCT00237198

Keywords

Versions (1)
  1. 11/23/16 11/23/16 -
Uploaded on

November 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Postmenopausal Women With Advanced Breast Cancer NCT00237198

English

Eligibility Postmenopausal Women With Advanced Breast Cancer NCT00237198

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically or cytologically documented breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)
Description

Breast Carcinoma Progressive | Advanced breast cancer | Breast cancer recurrent Local-Regional Inoperable | Breast Carcinoma Metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205329
UMLS CUI [2]
C3495917
UMLS CUI [3,1]
C0278493
UMLS CUI [3,2]
C1947913
UMLS CUI [3,3]
C0205187
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0036525
patients with hormone receptor (er and/or pgr) positive or both unknown.
Description

Hormone Receptor Positive | Estrogen receptor positive | progesterone receptor positive | estrogen receptor status unknown | progesterone receptor status unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4]
C0279758
UMLS CUI [5]
C0279768
postmenopausal patients between ages 20 and 79 years, inclusive
Description

Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens
Description

Adjuvant therapy | Antioestrogen therapy Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2,1]
C0854638
UMLS CUI [2,2]
C3495917
patients with documented measurable or evaluable lesions.
Description

Measurable lesion | Lesion Evaluable

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1516986
patients with sufficient organ function to evaluate the safety
Description

Organ function Sufficient Evaluation Safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0036043
patients whose performance status (ps) is 0～2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with diffuse lymphangitis carcinomatosa of the lung or cns involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer
Description

Lymphangitis carcinomatosa Diffuse Lung | Central Nervous System Involvement | Secondary malignant neoplasm of liver Extent | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0238258
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0024109
UMLS CUI [2]
C4050309
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0439792
UMLS CUI [4]
C0278601
patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin)
Description

Malignant Neoplasms | Contralateral breast cancer | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1096616
UMLS CUI [3]
C0851140
UMLS CUI [4,1]
C0007117
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0553723
UMLS CUI [5,2]
C1522326
patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites
Description

hilar enlargement | Pleural effusion | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C0744903
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions
Description

Osteoblastic bone metastases Site | Osteolytic bone metastases Site | Measurable lesion | Lesion Evaluable

Data type

boolean

Alias
UMLS CUI [1,1]
C3854652
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C1515974
UMLS CUI [3]
C1513041
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1516986
patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease)
Description

Disease Serious | Heart Disease Uncontrolled | Diabetic - poor control | Heart Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0421258
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205404
patients with adrenal insufficiency (treated or untreated) or cushing's syndrome
Description

Adrenal gland hypofunction | Adrenal gland hypofunction Treated | Cushing Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0001623
UMLS CUI [2,1]
C0001623
UMLS CUI [2,2]
C1522326
UMLS CUI [3]
C0010481
patients with any of the following previous treatments
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
1. chemotherapy for metastatic and/or locoregional recurrent disease
Description

Chemotherapy Neoplasm Metastasis | Chemotherapy Recurrent disease Local-Regional

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C1947913
2. previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, lh-rh analogues or radiation castration
Description

prior adjuvant endocrine/hormonal therapy | Ovariectomy | Estrogen Antagonists | Luteinizing Hormone-releasing Hormone Agonist | Radiation castration

Data type

boolean

Alias
UMLS CUI [1]
C0281266
UMLS CUI [2]
C0029936
UMLS CUI [3]
C0014930
UMLS CUI [4]
C1518041
UMLS CUI [5]
C0877129
3. previous first-line endocrine therapy (e.g., aromatase inhibitors and gastagens) for the treatment of metastatic and/or locoregional recurrent breast cancer other than anti-estrogen or lh-rh analogues treatment
Description

hormones first line of treatment Breast Carcinoma Metastatic | hormones first line of treatment Breast cancer recurrent Local-Regional | Aromatase Inhibitors | Progestins | Estrogen Antagonists | Luteinizing Hormone-releasing Hormone Agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C2046986
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0036525
UMLS CUI [2,1]
C2046986
UMLS CUI [2,2]
C0278493
UMLS CUI [2,3]
C1947913
UMLS CUI [3]
C0593802
UMLS CUI [4]
C0033306
UMLS CUI [5]
C0014930
UMLS CUI [6]
C1518041
4. patients who have not recovered from toxicity caused by previous therapy
Description

Toxic effect caused by Prior Therapy | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
5. for patients on investigational drugs, adequate wash-out periods of at least 7 days in the case of topical investigational drugs and at least 30 days in the case of systemic
Description

Investigational New Drugs | Washout Period Duration | Investigational New Drugs Topical | Investigational New Drugs Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1710439
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0205373
6. previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions
Description

Diphosphonates | Measurable lesion | Lesion Evaluable

Data type

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1516986
7. patients who have not stopped treatment with other anti-estrogen or anti-cancer drugs (other than bisphosphonates) before starting the trial medication
Description

Estrogen Antagonists Discontinued | Antineoplastic Agents Discontinued | Diphosphonates

Data type

boolean

Alias
UMLS CUI [1,1]
C0014930
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1444662
UMLS CUI [3]
C0012544
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 Postmenopausal Women With Advanced Breast Cancer NCT00237198

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
patients with histologically or cytologically documented breast cancer
boolean
C0678222 (UMLS CUI [1])
Breast Carcinoma Progressive | Advanced breast cancer | Breast cancer recurrent Local-Regional Inoperable | Breast Carcinoma Metastatic
Item
patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)
boolean
C0678222 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C3495917 (UMLS CUI [2])
C0278493 (UMLS CUI [3,1])
C1947913 (UMLS CUI [3,2])
C0205187 (UMLS CUI [3,3])
C0678222 (UMLS CUI [4,1])
C0036525 (UMLS CUI [4,2])
Hormone Receptor Positive | Estrogen receptor positive | progesterone receptor positive | estrogen receptor status unknown | progesterone receptor status unknown
Item
patients with hormone receptor (er and/or pgr) positive or both unknown.
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C0279758 (UMLS CUI [4])
C0279768 (UMLS CUI [5])
Postmenopausal state | Age
Item
postmenopausal patients between ages 20 and 79 years, inclusive
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adjuvant therapy | Antioestrogen therapy Advanced breast cancer
Item
patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens
boolean
C0677850 (UMLS CUI [1])
C0854638 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
Measurable lesion | Lesion Evaluable
Item
patients with documented measurable or evaluable lesions.
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
Organ function Sufficient Evaluation Safety
Item
patients with sufficient organ function to evaluate the safety
boolean
C0678852 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
performance status
Item
patients whose performance status (ps) is 0～2
boolean
C1518965 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphangitis carcinomatosa Diffuse Lung | Central Nervous System Involvement | Secondary malignant neoplasm of liver Extent | Inflammatory Breast Carcinoma
Item
patients with diffuse lymphangitis carcinomatosa of the lung or cns involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer
boolean
C0238258 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,3])
C4050309 (UMLS CUI [2])
C0494165 (UMLS CUI [3,1])
C0439792 (UMLS CUI [3,2])
C0278601 (UMLS CUI [4])
Malignant Neoplasms | Contralateral breast cancer | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
C1096616 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0007117 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0553723 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
hilar enlargement | Pleural effusion | Ascites
Item
patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites
boolean
C0744903 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Osteoblastic bone metastases Site | Osteolytic bone metastases Site | Measurable lesion | Lesion Evaluable
Item
patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions
boolean
C3854652 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3])
C0221198 (UMLS CUI [4,1])
C1516986 (UMLS CUI [4,2])
Disease Serious | Heart Disease Uncontrolled | Diabetic - poor control | Heart Disease Serious
Item
patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease)
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0421258 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Adrenal gland hypofunction | Adrenal gland hypofunction Treated | Cushing Syndrome
Item
patients with adrenal insufficiency (treated or untreated) or cushing's syndrome
boolean
C0001623 (UMLS CUI [1])
C0001623 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0010481 (UMLS CUI [3])
Prior Therapy
Item
patients with any of the following previous treatments
boolean
C1514463 (UMLS CUI [1])
Chemotherapy Neoplasm Metastasis | Chemotherapy Recurrent disease Local-Regional
Item
1. chemotherapy for metastatic and/or locoregional recurrent disease
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C1947913 (UMLS CUI [2,3])
prior adjuvant endocrine/hormonal therapy | Ovariectomy | Estrogen Antagonists | Luteinizing Hormone-releasing Hormone Agonist | Radiation castration
Item
2. previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, lh-rh analogues or radiation castration
boolean
C0281266 (UMLS CUI [1])
C0029936 (UMLS CUI [2])
C0014930 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
C0877129 (UMLS CUI [5])
hormones first line of treatment Breast Carcinoma Metastatic | hormones first line of treatment Breast cancer recurrent Local-Regional | Aromatase Inhibitors | Progestins | Estrogen Antagonists | Luteinizing Hormone-releasing Hormone Agonist
Item
3. previous first-line endocrine therapy (e.g., aromatase inhibitors and gastagens) for the treatment of metastatic and/or locoregional recurrent breast cancer other than anti-estrogen or lh-rh analogues treatment
boolean
C2046986 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,3])
C2046986 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C1947913 (UMLS CUI [2,3])
C0593802 (UMLS CUI [3])
C0033306 (UMLS CUI [4])
C0014930 (UMLS CUI [5])
C1518041 (UMLS CUI [6])
Toxic effect caused by Prior Therapy | Patient Recovered
Item
4. patients who have not recovered from toxicity caused by previous therapy
boolean
C0600688 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Investigational New Drugs | Washout Period Duration | Investigational New Drugs Topical | Investigational New Drugs Systemic
Item
5. for patients on investigational drugs, adequate wash-out periods of at least 7 days in the case of topical investigational drugs and at least 30 days in the case of systemic
boolean
C0013230 (UMLS CUI [1])
C1710661 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1710439 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
Diphosphonates | Measurable lesion | Lesion Evaluable
Item
6. previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions
boolean
C0012544 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C1516986 (UMLS CUI [3,2])
Estrogen Antagonists Discontinued | Antineoplastic Agents Discontinued | Diphosphonates
Item
7. patients who have not stopped treatment with other anti-estrogen or anti-cancer drugs (other than bisphosphonates) before starting the trial medication
boolean
C0014930 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0012544 (UMLS CUI [3])
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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