Secondary malignant neoplasm of female breast Progressive
Item
participants with histologically proven diagnosis of progressive metastatic breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Measurable Disease
Item
participants with measurable disease as per the response evaluation criteria in solid tumors (recist) guidelines
boolean
C1513041 (UMLS CUI [1])
Secondary malignant neoplasm of bone | Diphosphonates Palliative Care | Measurable Disease Site
Item
participants with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present
boolean
C0153690 (UMLS CUI [1])
C0012544 (UMLS CUI [2,1])
C0030231 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
ECOG performance status | Toxicity Due to Prior Therapy | Patient recovered
Item
participants with eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 and adequately recovered from the acute toxicity of any prior treatment
boolean
C1520224 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
participants with serum creatinine less than or equal to 1.5 milligram per deciliter (mg/dl) or creatinine clearance greater than or equal to 30 milliliter per minute (ml/min)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Exposure to trabectedin
Item
participants with previous exposure to trabectedin
boolean
C0332157 (UMLS CUI [1,1])
C1311070 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity Neoplasm Metastasis | Hypersensitivity Component Trabectedin Intravenous | Dexamethasone allergy
Item
participants with more than 3 previous chemotherapy regimens for metastatic disease and known hypersensitivity to components of trabectedin intravenous formulation or dexamethasone
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C1311070 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0571611 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women or any women of childbearing potential who is not employing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Prior Therapy Completion | Therapeutic radiology procedure | Hormone Therapy | Biological treatment | Chemotherapy
Item
completion of previous therapy : less than 2 weeks from radiation therapy or last dose of hormonal therapy, less than 3 weeks from previous biological therapy or chemotherapy
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
Leptomeningeal disease | Illness Serious | Congestive heart failure | Angina Pectoris | Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia | Communicable Diseases | Mental disorders | Viral hepatitis
Item
participants with known leptomeningeal disease and other serious illnesses like congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrolment; uncontrolled arterial hypertension or arrhythmias or active infection or psychiatric disorder or active viral hepatitis
boolean
C0751297 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0042721 (UMLS CUI [10])