Eligibility Postmenopausal Women With Advanced Breast Cancer NCT00237198

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StudyEvent: Eligibility
1. Eligibility Postmenopausal Women With Advanced Breast Cancer NCT00237198

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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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Eligibility Postmenopausal Women With Advanced Breast Cancer NCT00237198