Confirmed invasive breast cancer
Item
Does the participant have a pathologically confirmed diagnosis of invasive breast cancer?
boolean
C0030664 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
C0853879 (UMLS CUI [1,3])
Stage IV disease
Item
Does the participant have stage IV disease?
boolean
C0278488 (UMLS CUI [1])
HER2 and hormone receptor status
Item
Does the participant have documented her2 and hormonal receptor status per protocol, er/pr+ patients must be refractory to at least one prior hormonal treatment.
boolean
C0175636 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C3824899 (UMLS CUI [1,3])
C0019929 (UMLS CUI [1,4])
C4745239 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
ECOG performance status
Item
Does the participant have a ecog performance status 0-1?
boolean
C1520224 (UMLS CUI [1])
Recist measurable disease
Item
Does the participant have measurable disease per recist (1.1)?
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
Adequate hematological function
Item
Does the participant have a adequate hematological function per protocol?
boolean
C0205411 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
C0442711 (UMLS CUI [1,4])
Adequate hepatic function
Item
Does the participant have an adequate hepatic function per protocol?
boolean
C0205411 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0442711 (UMLS CUI [1,4])
Adequate renal function
Item
Does the participant have an adequate renal function per protocol.
boolean
C0205411 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,3])
C0442711 (UMLS CUI [1,4])
Negative serum pregnancy test
Item
Does the participant have a negative serum pregnancy test at study entry for patients of childbearing potential?
boolean
C0430061 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Informed Consent
Item
Does the participant have the ability to understand and sign written consent and to comply with the study protocol?
boolean
C1273101 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1519316 (UMLS CUI [2,2])
C0009797 (UMLS CUI [2,3])
C0582783 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
CNS metastases
Item
Does the participant have presence of active or untreated cns metastases as determined by mri/ct scan performed during screening?
boolean
C0205177 (UMLS CUI [1,1])
C0686377 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0332155 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0220908 (UMLS CUI [2,4])
Other active malignancies
Item
Does the participant have active malignancies other than mbc within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin?
boolean
C0205177 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C0007874 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Only bone metastases
Item
Does the participant have bone as the only site of metastatic disease from breast cancer?
boolean
C0027627 (UMLS CUI [1,1])
C4698125 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0153690 (UMLS CUI [1,4])
Prior Radiotherapy
Item
Does the participant have prior radiotherapy to the only area of measurable disease?
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
Pregnancy or lactation
Item
Does the participant have pregnancy or lactation?
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
Serious cardiac illness
Item
Does the participant have a known serious cardiac illness?
boolean
C0205404 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
Uncontrolled intercurrent illness
Item
Does the participant have uncontrolled intercurrent illness per protocol?
boolean
C0205318 (UMLS CUI [1,1])
C3640977 (UMLS CUI [1,2])
Medical condition interfering with study aspects
Item
Does the participant have other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study?
boolean
C0205082 (UMLS CUI [1,1])
C4745084 (UMLS CUI [1,2])
C4699158 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0205191 (UMLS CUI [2,1])
C4745084 (UMLS CUI [2,2])
C4699158 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0205082 (UMLS CUI [3,1])
C4745084 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0459471 (UMLS CUI [3,4])
C0683954 (UMLS CUI [3,5])
C0205191 (UMLS CUI [4,1])
C4745084 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0459471 (UMLS CUI [4,4])
C0683954 (UMLS CUI [4,5])
C0205082 (UMLS CUI [5,1])
C4745084 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C1548788 (UMLS CUI [5,4])
C0205191 (UMLS CUI [6,1])
C4745084 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C1548788 (UMLS CUI [6,4])