Breast Carcinoma unresectable | Carcinoma breast stage IV de novo
Item
1. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease.
boolean
C0678222 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0278488 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
Triple-Negative Breast Cancer Finding | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Immunohistochemistry | Human epidermal growth factor 2 negative carcinoma of breast | Human epidermal growth factor 2 gene amplification negative | Fluorescent in Situ Hybridization
Item
2. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er <1%, pr <1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator.
boolean
C2348819 (UMLS CUI [1])
C2919271 (UMLS CUI [2])
C2919590 (UMLS CUI [3])
C0069515 (UMLS CUI [4])
C0021044 (UMLS CUI [5])
C2316304 (UMLS CUI [6])
C3874302 (UMLS CUI [7])
C0162789 (UMLS CUI [8])
Prior Chemotherapy Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy
Item
3. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
boolean
C1514457 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
Measurable Disease Response Evaluation Criteria in Solid Tumors
Item
4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
ECOG performance status
Item
5. performance status no more than 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
6. all patients enrolled are required to have adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Life Expectancy
Item
7. life expectancy longer than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Heart Diseases | Lung diseases | Liver diseases | Kidney Diseases
Item
8. no serious medical history of heart, lung, liver and kidney
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Comprehension Study Protocol Informed Consent
Item
9. be able to understand the study procedures and sign informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Compliance behavior Good
Item
10. patients with good compliance
boolean
C1321605 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Ultrasonics (sound)
Item
1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C1456803 (UMLS CUI [3,3])
Childbearing Potential | Unwilling Contraceptive methods
Item
2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
boolean
C3831118 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Therapeutic radiology procedure Entire axial skeleton | Toxic effect Prior radiation therapy
Item
3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C1321508 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
Therapeutic procedure Investigational New Drugs
Item
4. treatment with an investigational product within 4 weeks before the first treatment
boolean
C0087111 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
CNS metastases | Metastatic malignant neoplasm to brain | Cranial Irradiation | Measurable Disease | Therapeutic radiology procedure
Item
5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C0079172 (UMLS CUI [3])
C1513041 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Malignant Neoplasms | Hematologic Neoplasms | Skin carcinoma | Cervical Intraepithelial Neoplasia
Item
6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
boolean
C0006826 (UMLS CUI [1])
C0376545 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0206708 (UMLS CUI [4])
Cardiovascular Diseases | Liver diseases | Respiration Disorders | Kidney Diseases | Abnormality of blood and blood-forming tissues | Abnormality of the endocrine system | nervous system disorder | Mental disorders
Item
7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0850715 (UMLS CUI [5])
C4025823 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
Communicable Diseases Uncontrolled
Item
8. uncontrolled serious infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])