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])
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])